Persons with HIV (PWH) can now achieve a near-normal life expectancy due to antiretroviral therapy (ART). Despite widespread availability of ART in the United States (US), many of the country’s approximate 1.1 million PWH are not achieving viral suppression due to poor ART adherence. Viral suppression rates are particularly low in Alabama  and New York City . There is mixed evidence on the efficacy of community health workers (CHW) and mHealth interventions for improving ART adherence and viral suppression in PWH thus, we sought to combine these interventions and test the efficacy for improving health outcomes in PWH.n = 150 in AL and 150 in NYC) over the course of 12 months. Participants are randomly assigned to CHAMPS (intervention) or a standard-of-care (control) arm. Participants in the intervention arm are given a CleverCap pill bottle that syncs to the WiseApp to track medication adherence, reminds users to take their medication at a set time, and enables communication with CHW. All participants complete baseline, 6-month, and 12-month follow-up visits where surveys are administered and, CD4 and HIV-1 viral load are obtained through blood draw.The CHAMPS study is a two-arm randomized controlled trial among 300 PWH with suboptimal primary care appointment adherence  on 9/24/20. Persons with HIV (PWH) now achieve near-normal life expectancy due to antiretroviral therapy (ART), which has transformed HIV from a terminal diagnosis to a manageable chronic condition –4. HowevThe Deep South, a colloquial term comprising nine US states, including AL, had the highest HIV diagnosis rates of any US region during the past decade . Poorer Progression of HIV disease and premature deaths among PWH have been attributed foremost to insufficient engagement in medical care and adherence to HIV treatment regimens . FollowiOur team conducted two prior studies to support the independent use of CHW and mHealth interventions as described. Firstly, the Birmingham Access to Care (BA2C) study (NCT02525146) was a single-site randomized controlled trial (RCT) funded by AIDS United and conducted between July 2013 and February 2016 in partnership with Birmingham AIDS Outreach (BAO), and the University of Alabama at Birmingham (UAB) 1917 HIV Outpatient Clinic. The study focused on re-engagement in care among PWH who had previously established care but were not engaged at the time of the study. The BA2C intervention was based on a CDC-recognized evidence-based intervention, Anti-Retroviral Treatment and Access to Services (ARTAS), which was the first RCT shown to significantly increase linkage to care among recently diagnosed PWH –36. The More so, our WiseApp study (NCT03205982) utilized a self-management app for PWH  with theBuilding on our preliminary work, the CHAMPS study aims to enable PWH in the two high priority settings of Birmingham, AL and NYC to self-manage their ART regimens supported by bidirectional communication via mHealth technology and CHW who monitor their ART adherence in real-time through the use of the WiseApp App and provide support in overcoming barriers to HIV care. Specifically, the study is an RCT that assesses the efficacy and sustainability of CHAMPS on viral suppression (primary outcome) and ART adherence (secondary outcome) compared to the standard of care (control group) over 6 and 12 months, as well as to identify mediators and moderators on study outcomes. This paper provides an overview of the CHAMPS protocol.All study procedures were reviewed and approved by the Western Institutional Review Board. Study participants will provide written informed consent and HIPAA authorization prior to enrollment. Researchers follow institutional policies on data collection and management procedures.n = 150 in AL and 150 in NYC) over 12 months. Participants are randomly assigned to CHAMPS (intervention) or a standard-of-care (control) arm. Comparison of study arms is illustrated in Table The study is a two-arm RCT among 300 PWH  Able to speak, read, and write in English or Spanish (NYC site only); 2) aged ≥ 18 years; 3) willing to participate in any assigned arm of the intervention; 4) diagnosed with HIV ≥ 6 months ago; 5) Have an HIV-1 RNA level ≥ 200 copies/mL, or at least one “no-show” visit, in the past 12 months, or report being virally unsuppressed in the past 12 months; 6) own a smartphone; and 7) ability and willingness to provide informed consent for study participation and consent for access to medical records. Participants are not eligible if they meet any exclusion criteria, including: 1) Reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment; 2) terminal illness with life expectancy < 6 months; 3) planning to move out of the area in the next 12 months; and/or participating in a study that targets viral suppression for PWH. The study team carefully considered including newly diagnosed participants (diagnosed < 6 months) and chose not to include this subset of PWH because newly diagnosed individuals are often treatment naïve; thus, their adherence behaviors are unknown and may change frequently as they begin their ART regimen.Participants are recruited using the following strategies (these approaches have been successfully used by our team in past studies –45): Flyn = 150 in each site) with a 1:1 random assignment to the intervention arm and the control arm . All power estimates are based on α = 0.05 and 2-sided tests and the following assumptions: (1) an 80% retention rate at each follow-up assessment for each study arm; (2) a correlation of 0.6 of outcome measure for participants at different time points of assessment; (3) an intra-cluster correlation (ICC) of 0.2 of participants of same study sites; and (4) 75% baseline viral suppression rate (based on preliminary data of the BA2C study). For the total sample (n = 300), we calculated power of at least 80% in order to detect a difference of 12% or greater in viral suppression. The 12% difference in viral suppression is equivalent to a small effect size (Cohen’s D of 0.31).The statistical power was calculated based on the primary outcome of viral suppression . 300 participants will be enrolled  between CHAMPS and standard of care. We will also compare decrease in viral load  between the two groups. Our secondary and related outcome is ART adherence measured in two ways: 1) a single-item, self-report, empirically validated measure (SRSI)  and 2) eThe primary hypothesis will be tested using a generalized linear mixed model (GLMM) with logit-link function for binary outcomes  or a linear mixed model (LMM) for continuous outcomes  to account for the non-independence of repeated measurements within individuals . The modMaintaining ART adherence has significant implications in HIV management and onward transmission . Thus, iThe guiding framework of the RCT is the conceptual model of supportive accountability, which is based on the premise that human support increases medication adherence through accountability to a coach—i.e., CHW—who is perceived as trustworthy, knowledgeable, and benevolent . The rapUtilizing mHealth technologies in CHAMPS may increase ART adherence . For insImportantly, the COVID-19 pandemic impacted healthcare approaches worldwide, prioritizing online care and restricting in-person access to healthcare providers, such as CHW . During


People living with HIV (PLHIV) have a greater risk of developing respiratory disorders. The problems are linked to poor socio-economic status, high viral load, low CD4 counts, and antiretroviral therapy. Despite the high prevalence of respiratory disorders, the association between HIV infection and pulmonary function status, as well as the associated factors, is not well established in resource-limited countries.A comparative cross-sectional study was conducted from September 24 to October 15 2020 at Jimma Medical Center among people living with HIV who were arranged into an age–sex-matched comparison group. Data were collected using a pretested structured questionnaire administered via face-to-face interviews. The collected data included socio-demographic, respiratory, HIV infection, and substance use variables. Pulmonary function tests were conducted using an SP10 spirometer. The collected data were entered and analyzed using SPSS version 26. Independent t-test and multiple linear regressions were carried out to identify factors associated with the pulmonary function status of the study participants.s (l) , and PEFR , with a significant lowering in the study group. Female sex, respiratory symptoms, duration of HIV, duration of treatment, and khat chewing were associated with lowered FEV1s (l) (p < 0.05) in HIV-positive respondents.A total of 96 PLHIV and 96 matched control individuals participated in the study. The mean of pulmonary function test parameters among the PLHIV respondents was FVC (l) , FEV1. As a result, health providers should screen HIV-positive patients with respiratory symptoms, prolonged duration of HIV infection, prolonged treatment, and khat chewing for non-infectious lung disorders while treating them.PLHIV had significantly lower mean lung function parameters than HIV-uninfected participants AIDS is a syndrome caused by HIV that predominantly targets and destroys a cluster of differentiation 4 T cells (CD4 cells) , 2. It iThe lung is a chief target organ for retroviral infection, rendering it vulnerable to an inclusive array of infectious and non-infectious complications . InnovatThe incidence of non-communicable diseases, particularly chronic non-infectious pulmonary diseases, dramatically increase in PLHIV after HAART . Obstrucα1-antitrypsin (AAT)  , and higin (AAT) .Socio-demographic factors , history of pulmonary tuberculosis, smoking, substance use, time of HAART initiation, CD4 count, viral load, and HAART have been crudely associated with pulmonary disease development and progression in PLHIV .Despite these facts, the screening, diagnosing, and managing of non-infectious chronic lung diseases by interpreting pulmonary function test indices have been under-emphasized in PLHIV . DespiteThis study was conducted at Jimma University Medical Centre (JUMC) from September 24 to October 15 2020. JUMC is located in Jimma city, 352 km southwest of Addis Ababa. It provides services for approximately 15,000 inpatients, 160,000 outpatient attendants, 11,000 emergency cases, and 4,500 deliveries a year for patients coming to the hospital from the catchment population of about 15 million people. Currently, 3,029 PLHIV are registered and receive service in the ART clinic.An institution-based comparative cross-sectional study design was used for this study.The source population for the study group was all PLHIV attending the ART clinic at JUMC. The comparison group was HIV uninfected and age- and sex-matched, and it included the caregivers of the attendees >18 years.The study population for the study group comprised all the selected PLHIV attending the ART clinic and the age- and sex-matched HIV-uninfected attendants of age >18 years during the study period. During the matching procedure, we established an age- and sex-matched comparison group for each study group. The age-matching procedure allowed for a two-age deviation.The inclusion criteria for the study group were all PLHIV who had begun HAART 6 months before the study period. The comparison group comprised HIV-uninfected and age- and sex-matched individuals, and the caregivers of these PLHIV attendees >18 years were included in the study.PLHIV who had been diagnosed with chronic co-morbidities , pregnancy, <6 months of HAART, severe illness, history of retinal detachment, abdominal surgery <3 months ago, chest/abdominal surgery <3 months ago, and presumed COVID -19 were excluded. Similar exclusion criteria were used for a comparison group. The study respondents were selected based on the inclusion and exclusion criteria of the study, as shown in the flow chart .The sample size was calculated using the double proportion population formula by taking the proportion of obstructive lung disease among PLHIV (P1 = 10%) and HIV-negative respondents (P2 = 3%) extracted from a study conducted in a rural part of South Africa . The conData were collected using an interviewer-administered structured questionnaire. It had five distinct parts: socio-demographic characteristics, a respiratory-related questionnaire, substance use, anthropometry, and spirometer measurements. HIV-related questionnaires were reviewed from the study participants' medical records. Respiratory-related questionnaires were adapted from the St. George's Respiratory Questionnaire .Consented respondents from the comparison group had HIV tests using a rapid HIV diagnostic kit. The procedure and result interpretation were based on the Ethiopian Health and Nutrition Research Institute . Weight 25%–75%), and peak expiratory flow rate in liter per seconds (PEFR (l/s).The pulmonary function tests (PFT) were measured using the SP10 digital spirometer . The PFT parameters measured by the spirometer were forced vital capacity in liter and percent predicted (FVC), forced expiratory volume in the first seconds in liter and percent predicted (FEV1s), FEV1s/FVC, forced expiratory flow at 25%–75% of FVC (FEF1 (l) must agree with 150 milliliters (ml).The procedure, precaution, acceptability, reproducibility, and interpretation of the spirometer output were based on the CDC-National Health and Nutrition Examination Survey of Respiratory Health and its research article . The criThe body of the spirometer and turbine was cleaned using 70% isopropyl alcohol at the end of each procedure. The data collectors were wearing N-95 facemasks and powder-free disposable gloves after demonstrating the maneuver for the study respondents. Each study participant had a mouthpiece with a bacterial–viral filter, which was discarded at the end of the procedure. In line with COVID-19 prevention, all preventive measures and recommendations from the World Health Organization were kept in place.The instrument's calibration was based on the SP-10 pocket spirometer user manual that the manufacturer prepared. Under the calibration interface, verification was checked for pre-calibration with a 3l syringe.Qualified personnel performed a spirometer examination in a quiet room in a sitting position. The procedure was conducted in the morning between 8:00 AM and 12:00 AM daily at room temperature. Each participants' ID, age, sex, weight, height, race, and smoking status were fed into the SP10 spirometer before the maneuver. A very explicit instruction was delivered to the study participants until a common understanding was grounded for the spirometer examination.Each study participant was sitting upright with their chin elevated and neck extended slightly, feet flat on the ground with an uncrossed leg, and holding their nostrils tightly by the left/right thumb and index fingers. They then took a big deep breath and filled their lungs with air. Holding the spirometer and placing the mouthpiece into their mouth above the tongue and between the teeth, the participant then blasted out the air as hard and as fast as possible and kept blowing out for the first 6 s to empty the lung. The procedure was repeated until three acceptable and reproducible measurements were obtained, with a maximum of eight attempts. The procedure was stopped and rescheduled if the participant could not produce an acceptable and repeatable spirometer output after eight attempts. Four BSc nurse professionals who had previous experience in data collection collected the data.Respiratory symptoms–a Saint George's respiratory questionnaire score >24 is considered a prevalent respiratory symptom.Alcohol taking–a male drinking ≥ 2 bottles of beer per drinking session and a female drinking ≥ 1 bottle of beer per drinking session over ≥ 3 sessions/week within one month before the study.Khat chewer–chewing ≥ 1 bundle of khat leaves per chewing session ≥ 3 days/week for one month before the study.The collected data were cleaned, coded, entered into epi-data manager (v.4.6.0.2) and epi-data entry client (v.4.6.0.2), and exported into SPSS version 26 for data analysis.Using SPSS, continuous variables were summarized as mean and standard deviation using descriptive statistics. Categorical variables were summarized as frequency and percentage using cross-tabulation.An Independent t-test was used to compare the mean of the pulmonary function test indices between the PLHIV and HIV-negative study respondents. The assumption of an independent sample t-test was checked using the Shapiro–Wilk and Levine's tests.s (l) in simple linear regression were entered into multiple linear regression (p < 0.25).Linear regression was used to investigate the factors that predict FEV1 (l) in PLHIV patients. Variables that were significant predictors of FEV1Multiple linear regression analysis was utilized to obtain the best-fit linear combination of sex, respiratory symptoms, history of pulmonary TB, duration of RVI, duration of treatment, treatment regimen, current CD4 cell count, and khat chewing, which were significant in simple linear regression.p-value of < 0.05 were said to be a significant predictor of FEV1s (l).The assumption of multiple linear regression  was checked and met. Normality was checked using histogram, P-P, and Q-Q plots. Multicollinearity was checked using the variance inflation factor (VIF), and VIF >5 shows an association between predictor variables. The recruited variables in multiple linear regression that had a Training for data collectors and supervisors was given by the principal investigator for two consecutive days on the purpose of the study, interview and measurement techniques, and ethical issues. The principal investigator checked for the completeness and clarity of the collected data.A total of 192 (96 PLHIV and 96 HIV-negative) were recruited for the study. The response rate of the study respondents was 100%. Among the total respondents, 65% were female. The mean ages of PLHIV and HIV-negative respondents were 37.56 years (SD = ±7.017) and 36.06 years (SD = ±7.20), respectively. Regarding the level of education, 6.3% of PLHIV respondents and 14.6% of HIV-negative respondents were unable to read and write , and 9.32) of PLHIV and HIV-negative respondents was 21.85 (SD = ±3.57) and 21.49 (SD = ±7.63), respectively. Moreover, 6.8% and 2.6% of PLHIV and HIV-negative respondents reported a history of TB.The mean height (meter) of PLHIV and HIV-negative respondents was 1.63 (SD = ±0.86) and 1.65 (SD = ±0.110), respectively. The mean weight (kilogram) of PLHIV and HIV-negative respondents was 59.4 (SD = ±11.81) and 56.91 (SD = ±9.88), respectively. Similarly, the mean BMI  and 247.32 copies/ml , respectively. Regarding the viral load status, 95.8% of PLHIV respondents had a suppressed viral load. Among the virally suppressed PLHIV respondents, 81.5% of them had an undetectable viral load. Using the Medication Adherence Rating Scale (MARS score), it was found that 33.3% of the RVI respondents had poor adherence (The mean duration of HIV infection was 7.98 years (SD ± 4.64), and the mean duration of treatment was 7.15 years (SD ± 4.63). The mean of the current CD4 counts and current viral loads was 659 cells/mmdherence .The current study showed that the mean of the predicted FVC was significantly lower in PLHIV respondents (67.35 ± 19.12) than in HIV-negative respondents . Similarly, it revealed that the percentage means of predicted FEV1  and PEFR  were significantly lower in PLHIV than in HIV-negative respondents.25–75 (l/s)  showed no significant difference between PLHIV respondents and HIV-negative respondents  and FEFpondents .s (l) of the PLHIV respondents. As a result, a simple linear regression model revealed a significant association (p < 0.25) between FEV1s (l) and sex , height, respiratory symptoms (SGRQ score <24 being used as a reference), history of pulmonary TB (no. being used as a reference), duration of HIV infection, duration of treatment, treatment regimen (another treatment regimen being used as a reference), current CD4 cell count, and khat chewing (no. being used as a reference).A simple linear regression was employed to determine the factors that predict the FEV1s (l) (p > 0.25) among the PLHIV patients .Multiple linear regression analysis was utilized to obtain the best fit linear combination of sex, height, respiratory symptoms, duration of HIV infection, duration of treatment with HAART, treatment regimen, current CD4 count, history of pulmonary tuberculosis, and khat chewing, which were significant in simple linear regression (s (l) (p < 0.05). Conversely, height, current CD4 count, and pulmonary tuberculosis were not significant predictors of FEV1s (l) (p > 0.05). Being a female meant having FEV1s (l) lower than 0.579 liters compared to being a male .As a result, sex, respiratory symptoms, duration of HIV infection, duration of treatment with HAART, treatment regimen, and khat chewing were significant predictors of FEV1s (l) by 0.461 liters compared to those devoid of respiratory symptoms . Similarly, respondents who reported chewing khat decreased their FEV1s (l) by 0.453 liters compared to non-chewer respondents .Respondents who reported respiratory symptoms decreased FEV1s  when the history of pulmonary tuberculosis held constant. A unit increment in the duration of treatment resulted in a 0.09-liter decline in FEV1s (l) . Similarly, respondents who were in the first-line treatment regimen had 0.324-liters higher FEV1s (l) than respondents in other treatment regimens  (A unit increment in the duration of HIV infection resulted in a 0.08-liter decline in FEV1 p0.035) .The mean percentage of the predicted FEV1 was significantly more reduced in the PLHIV participants than in the HIV-negative participants in the current study. This report is concordant with a study conducted in Copenhagen . This obOur findings revealed that the mean percentage of predicted FVC was significantly reduced in PLHIV participants than in HIV-negative respondents. This observation aligns with studies conducted in Cape Town, South Africa, and Amsterdam , 19. TheBeing male was a positive predictor of FEV1 (l) in the current study. This finding was consistent with a study carried out in the United States . Apart fThe current study also reported that the duration of HAART treatment was a negative predictor of FEV1 (l). This result is inconsistent with studies conducted in Minneapolis and Pittsburg, United States , 24. ThiThe present study also revealed that the duration of HIV infection is a negative predictor of FEV1. This observation is consistent with studies carried out in Zimbabwe and Denmark , 27. HowSimilarly, the present study showed that the presence of respiratory symptoms is a negative predictor of FEV1 (l). This finding agrees with studies carried out in Nigeria and Baltimore , 29. It Our findings also showed that khat chewing is a negative predictor of FEV1 (l). The association between khat chewing and pulmonary function impairment has not been elucidated very well. It is possible that the negative association between khat chewing and reduced pulmonary function test is probably because khat chewing could interfere with the drug adherence and feeding appetite (anorexia) of PLHIV.Finally, the known influential predictors of FEV1  had no significant association in the present study. It can be suggested that the PLHIV study respondents in our study had no big differences in terms of age, height, and weight that could possibly cause variation in FEV1 within the study group.As part of our strength, this article is the first to study the effect of HIV infection on pulmonary function and to compare it with age- and sex-matched non-HIV-positive respondents. We extensively explore the potential risk factors that affect pulmonary function, including khat and alcohol use, HIV characteristics, drug adherence, and respiratory symptoms. The current study contributes its part to the present understanding of PLHIV and its impact on pulmonary function. Similarly, the current study highlights possible predictors of pulmonary function in PLHIV patients.Pulmonary functions were significantly reduced in PLHIV respondents compared to age- and sex-matched HIV-negative respondents. Sex, duration of HIV, duration of HAART treatment, khat chewing, respiratory symptoms, and treatment regimen were significant predictors of FEV1 (l) in PLHIV patients. Height, current viral load, current CD4 count, history of PTB, alcohol consumption, and degree of adherence had no significant association with FEV1 (l) in PLHIV participants. Based on the current results of this study, health providers should screen PLHIV patients with respiratory symptoms, prolonged duration of HIV infection, prolonged duration of treatment, and khat chewing for non-infectious lung disorders while treating them.


Achieving the UNAIDS 95% sustained viral suppression (VS) rate requires considerable global efforts, particularly among adolescents living with HIV (ALHIV) who are often associated with high rates of virological failure (VF). In this study, we prospectively assessed the rate of VS, and the factors associated with VF in a cohort of adolescents followed up according to the WHO guidelines in Cameroon.A cross-sectional study was carried out in 2021 among adolescents (aged 10–19 years) receiving ART in the national program in Cameroon. Socio-demographic and clinical data were collected using patients’ medical files and a brief interview with the participant and/or his guardian. Thereafter, a first viral load test (VL1) was performed using the ABBOTT Platform. For adolescents with VL1 > 1000 copies/ml, adherence-enhancing interventions were routinely performed each month for 3 consecutive months, after which a second viral load (VL2) was measured. Adolescents with VL2 > 1000 copies/ml were considered in VF.Overall, 280 adolescents were enrolled, of whom 89.3% (250/280) acquired HIV infection via mother-to-child transmission. The median age was 16.0 (IQR: 13.0–18.0) years and the median duration on ART was 9.8 (IQR: 5.1–12.8) years. Females and males were almost equally represented, as 52.1% (146/280) were female, while 47.9% (134/280) were males (p = 0.47). The VS rate was 88.2% (CI: 83.8-91.7%) overall; 89.0% (CI: 82.0-93.1%) and 88.7% (CI: 81.2-93.0%) in females and males, respectively. Being on second or third-line ART, self-declared suboptimal adherence, and a history of past VF were independently associated with VF.The high rate of VS we report in this study is welcome in the era of the 95/95/95 UNAIDS goals, and indicates that improving treatment outcomes in this specific and fragile population that represent adolescents in Sub-Saharan Africa is achievable.https://clinicaltrials.gov/ct2/show/NCT04593979).20/10/2020 NCT04593979 ( In its 2021 report, the UNAIDS highlighted poor treatment outcomes among adolescents. Here, we report a virological suppression rate of 88.2% among adolescents. Our experience can guide future options to improve care and treatment in this key and fragile population.The human immunodeficiency virus (HIV) remains a major public health concern, which is amplified by the difficulties in accessing essential HIV prevention, testing, and treatment services due to the COVID-19 pandemic . BesidesIn 2014, the Joint United Nations Programme on HIV/AIDS (UNAIDS) adopted ambitious fast-track targets that is by 2020, 90% of people living with HIV know their HIV status, 90% of people who know their status receive treatment, and 90% of people on treatment have suppressed viral load (VL). Recently, this target was increased to 95% by 2025  and achiIn Cameroon, the HIV prevalence was estimated to be 3.4% in the general population . Based oIn this study, we prospectively assessed the rate of VS and the factors associated with virological failure (VF) in a cohort of adolescents living with HIV (ALHIV) on ART in Cameroon, followed up according to the WHO guidelines.The study was a cross-sectional assessment that we conducted from February to September 2021. Eligible participants were adolescents, aged 10 to 19 years, receiving antiretroviral therapy (ART), followed up and monitored at the HIV/AIDS treatment center of the Laquintinie Hospital of Douala (LHD), a urban hospital setting in Douala, Cameroon. This HIV treatment center is the second-largest HIV/AIDS treatment center in the country, where an estimated number of 6000 patients under ART are monitored, among which almost 400 are adolescents. As a public health care clinic, patients are followed up and monitored according to national recommendations, which are mostly based on WHO public health recommendations for resources limited settings . AccordiAll the study participants were recruited in this clinic, using the following inclusion criteria: being infected with HIV-1, aged 10–19 years, on ART for a minimum of six months regardless of the ART regimen, and providing parental informed consent and adolescent assent. Sociodemographic and clinical characteristics were collected in medical records using a standardized case report form. Information regarding the number of missed pills over the last five days and the educational level were obtained after interviewing the participant and/or his parent/guardian. Blood specimens were collected at the inclusion visit for the initial VL testing, called VL1. Participants with VL1 < 1000 copies/ml were considered as VL suppressed according to national and WHO guidelines. For those presenting VL1 ≥ 1000 copies/ml, actions were conducted to reinforce treatment adherence, including therapeutic education and enhanced adherence counseling, and a second VL testing (VL2) was performed three months later from the first testing. Participants with VL2 < 1000 copies/mL were considered virally suppressed, while those with VL2 ≥ 1000 copies/ml were considered in virological failure (VF) and were eligible for treatment line modification.m2000rt HIV-1 assay  and following the manufacturer’s instructions. To guarantee the quality of results, the Laquintinie Retrovirology Laboratory is part of an international program that supports and assesses molecular biology laboratories in Africa, the Opp-Era Program .Laboratory testing was performed according to routine VL testing procedures at the study site. Briefly, whole blood specimens were collected using Ethylenediaminetetraacetic acid tubes and transferred within an hour to the reference study laboratory, the Retrovirology Laboratory of the LHD. Upon reception, samples were processed by centrifugation and the recovered plasma specimens were stored at -80 °C for further utilization. HIV-1 VL testing was performed using the Abbott Adolescents’ characteristics at enrolment were described and compared between girls and boys, and between those infected via mother-to-child transmission of HIV and the others using a chi-2 test or Fisher exact test for categorical variables, and Wilcoxon non-parametric test for continuous variables. The primary outcome of this study was the proportion of adolescents achieving viral suppression (VS) in our study population. The proportions of VS and VF with the 95% confidence interval was computed and data were summarized using tables. Participants were considered in VF if they had two consecutive plasma HIV-1 VL ≥ 1000 copies/mL within a three months interval, following the WHO guidelines . On the This study was conducted in accordance with Declaration of Helsinki and written informed consent and assent was respectively obtained from parents/guardians and adolescents in accordance with the Declaration. In addition, the study was approved by the Cameroon National Ethics Committee for Research and Human Health (2020/09/1293/CE/CNERSH/SP) and the Ministry of Public Health under authorization (130–857/MINSANTE/SG/DROS/CRSPE/BBM). All necessary efforts were done to guarantee patients’ confidentiality throughout the study.Overall, we recruited 280 adolescents. Girls and boys were almost equally represented as 52.1% (146/280) were female (p = 0.47). The median age was 16.0 (IQR: 13.0–18.0) years, with almost no difference between girls and boys (p: 0.99). The majority of the participants had a secondary educational level, 75.7% (212/280), 21.8% were at primary school, and 2.5% reached the university level. Moreover, 89.3% (250/280) acquired HIV infection via vertical transmission by mother-to-child transmission (MTCT), and 10.7% (30/280) by other routes. As regards to the knowledge of their HIV status, 57.4% (160/280) knew their status, and the others were not fully informed  of the adolescents were on a first-line regimen, 46.8% (131/280) were on a second-line, and 2 children were receiving a third-line ART. Current ART regimens included Tenofovir/Abacavir + Lamivudine + Efavirenz for first-line treatment, and Tenofovir/Abacavir + Lamivudine + Lopinavir boosted by ritonavir for second-line regimens. One-half of the study participants were receiving ART for almost 10 years, with the median duration on ART significantly longer (p < 0.001) among perinatally-infected adolescents  years compared to the others  years. Regarding the routine access to virological monitoring, 72.5% (203/280) had at least one VL assessment conducted in the last 12 months before study initiation ; with no difference according to the gender, 89.0% (CI: 82.0-93.1%) for girls and 88.7% (CI: 81.2-93.0%) for boys.Factors independently and significantly associated with higher odds of VF were being on second or third-line ART (p = 0.07), self-declared suboptimal adherence (p = 0.043), and having received a previous VL result ≥ 1000 copies/mL in the last 12 months (p = 0.014). Conversely, gender, age groups, and duration on ART or infection route were not associated with failure. When defining failure on the 1st VL ≥ 1000 copies/mL only, results were very similar. Moreover, among adolescents with an initial detectable VL ≥ 1000 copies/mL, our results revealed that those receiving ART for 12 years or more are more likely to maintain a detectable VL ≥ 1000 copies/mL compared to those who have been treated for a shorter time  of VL suppression among HIV-infected adolescents followed up according to national and WHO recommendations in Cameroon, almost meeting the 2020 UNAIDS/WHO goal of 95% VS. These results support the achievability of this goal in challenging contexts as in Sub-Sharan Africa, provided that necessary actions are in place to improve access to ART and its routine monitoring in this population. However, because continuous access to optimized ART, VL testing, retention in care services and psychosocial support in resource-limited setting remains challenging in Cameroon and in other RLCs, we should still be cautioned on the high risks that virological failure and drug resistance represent in these settings. Particular attention should be given to adolescents with past history of VF, sub-optimal adherence or receiving second- or third-line regimens.


The objective of this study is to evaluate and compare clinical and virological characteristics of asymptomatic and mild symptomatic patients of severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) Omicron BA.2.2 variant infection and identify risk factors associated with the prolonged viral negative conversion duration.We conducted a retrospective observational study in a Shanghai (China) Fangcang shelter hospital from April 9 to May 17, 2022. The patient‐related demographic or clinical data were retrospectively recorded. Comparisons of demographic and clinical characteristics between asymptomatic and mild‐symptomatic patients were performed. Cox regression was performed to identify the risk factors of prolonged viral negative conversion duration.p = .943). Multivariate Cox analysis revealed that patients age ≥ 60 years had a significantly higher hazard ratio (HR) for prolonged viral NCD .A total of 551 patients confirmed with SARS‐CoV‐2 Omicron variant infection were enrolled in the study. Of these, 297 patients (53.9%) were asymptomatic and 254 patients (46.1%) had mild symptoms. When comparing the clinical and virological characteristics between the asymptomatic and mild symptomatic groups, several clinical parameters, including age, gender, time to viral clearance from the first positive swab, chronic comorbidities, and vaccination dose did not show statistically significant differences. In mild symptomatic patients, the median viral negative conversion duration (NCD) was 7 days (interquartile range [IQR]: 5–9), which was comparable to the median of 7 days (IQR: 5–10) in asymptomatic patients (Asymptomatic and symptomatic patients with non‐severe SARS‐CoV‐2 Omicron BA.2.2 variant infection have similar clinical features and virological courses. Old age was an independent risk factor for prolonged SARS‐CoV‐2 conversion time. Asymptomatic and symptomatic patients with nonsevere SARS‐CoV‐2 Omicron BA.2.2 variant infection have similar clinical features and virological courses. Old age was an independent risk factor for prolonged SARS‐CoV‐2 conversion time. In the waves of the COVID‐19 pandemic, the world is grappling with various variants of the virus, including Alpha, Beta, Gamma, Delta, and most recently, Omicron.Over time, the Omicron variant has acquired genetic mutations, resulting in several different sublineages that have been confirmed.The Omicron variant of SARS‐CoV‐2 has been reported to cause milder disease compared to previous predominant variants.22.1Retrospective data on patients with Omicron BA.2.2 infections, who were admitted to Wards B5 and C2 of the Fangcang Hospital at the National Exhibition and Convention Center in Shanghai, China, was gathered. Inclusion criteria included the following: (1) hospitalized patients infected with the SARS‐CoV‐2 virus; (2) asymptomatic or mild symptomatic patients defined by the consensus of Guidelines for diagnosis and treatment of novelcoronavirus (2019‐nCoV) infection of China . Patients with substantial missing data were excluded from this study. This retrospective observational study was approved by the Ethics Committee of the Fangcang shelter hospital. The register number was 2022YH‐1030‐1 . All subjects provided their informed consent.2.28.Before the initial surge of Omicron in 2022, Shanghai maintained a baseline level of intensive NPIs against potential outbreaks, which included stringent border control policies, symptom‐based surveillance, case isolation, tracing of close contacts (requires quarantine in separate facilities) and contacts of contacts, occupation‐based screening, targeted screening of individuals at high risk of infection, and a set of other social distancing measures such as travel restrictions and community confinement.2.3Ct) values. Higher viral loads were a result of the decreased Ct values. When one of the Ct values of the ORF1ab and N genes was <35, RT‐PCR was considered positive. Weak positive was defined as one of the ORF1ab and N genes having a Ct value between 35 and 40. Patients would be discharged from the Fangcang shelter hospital based on the latest coronavirus pneumonia diagnosis and treatment guidelines of China: nucleic acid test negative twice in a row; improved symptoms; average body temperature for three consecutive days or more; and two consecutive negative tests 24 h apart were achieved with Ct values of ORF1ab and N genes ≥ 35. The criterion of negative conversion was two consecutive negative viral PCRs in a minimum of 24 h intervals. The negative conversion duration was defined as the interval between the initial day of the positive nasopharyngeal swab and the date of negative conversion.Patients’ demographic and clinical information, such as gender, age, comorbidities, vaccine dose, diagnosis date, and admission date, were recorded on the day of admission. Pharyngeal swab specimens were acquired to detect SARS‐CoV‐2 nucleic acid daily during hospitalization. Open reading frame 1ab (ORF1ab) and nucleocapsid protein (N) were the two targeted genes of a real‐time polymerase chain reaction (RT‐PCR). The fluorescent signal counts were used to calculate cycle threshold Ct values.2.4χ2, Fisher's exact, t test, and Mann–Whitney U test when necessary. Kaplan–Meier curves were plotted to describe the cumulative probability of negative viral conversion and comparisons stratified by factors were performed by log‐rank test. A multivariate Cox regression model was then performed with the significant factors identified by univariate analysis (p < .1), to determine the independent predictors of prolonged RNA‐negative conversion. Statistical analyses were performed using SPSS V.25.0. A difference with p < .05 was considered significant.Categorical data were shown as frequencies and percentages. Continuous variables were presented as the mean and standard deviation or as the median and interquartile range (IQR). Comparisons of variables among subgroups were performed using 33.1A total of 551 confirmed infected patients were enrolled for study in Ward B5 and C2 of the temporal hospital at the National Exhibition and Convention Center from April 9 to May 17, 2022  patients were 60 years or older. Sixty‐four patients (11.6%) had comorbidity (Table 3.2p = .156). In terms of percentage, more symptomatic cases  than asymptomatic cases (9.4%) had at least one chronic comorbidity. Besides, there was no statistically significant difference in gender distribution, the median viral shedding time, and vaccination doses between the two groups . We also compared the Ct values of ORF1ab and N genes on the admission day . Regarding the Ct values of the N gene, a significant difference was also discovered (p = .044).We compared baseline demographic and clinical characteristics between asymptomatic and mild symptomatic patients. As shown in Table 3.3p = .943). Patients aged ≥ 60 years had a median time to RNA viral conversion of 9 days (IQR: 6–11 days), which was substantially longer than patients aged < 60 years, who had a median time of 7 days (IQR: 5–9)  was 7 days in all patients (IQR: 5–10 days). Kaplan–Meier curves showed the cumulative probability of negative viral conversion stratified by different subgroups. As shown in Figure ) Figure . Additio) Figure . Individ) Figure  and vacc) Figure .p = .0002) and chronic comorbidities  had prolonged negative conversion duration compared with those patients without the above factors. In multivariate Cox regression, only age ≥ 60 years ; p = .039) was identified as an independent risk factor for prolonged negative conversion duration of viral RNA in asymptomatic and mild symptomatic patients with Omicron BA.2.2 variant infection.As shown in Table 4The study enrolled a total of 551 cases infected with the SARS‐CoV‐2 Omicron BA.2.2 variant. Of these, 297 patients (53.9%) were asymptomatic and 254 patients (46.1%) were mild symptomatic. The results show that nonsevere patients infected with the Omicron BA.2.2 variant had a high proportion of asymptomatic infections. Compared to the proportion of asymptomatic infection in nonsevere COVID‐19 cases in 2020 (29.4%), there were more asymptomatic infections during the omicron BA.2.2 variant wave.Ct values than the asymptomatic patients in the study. Our finding of lower Ct values in symptomatic patients and longer duration of viral shedding in older patients is in line with observations of higher household transmission rates from symptomatic versus asymptomatic index cases and index patients older than 60 years compared with adults, adolescents, and children under the age of 12 years.Notably, among 254 symptomatic patients, 76.1% presented at least two symptoms. The most common symptom was cough (41.6%), followed by sore throat (25.0%). This observation is consistent with previous studies, which found that upper respiratory tract symptoms  were more common in patients with Omicron infection than those with delta variant infection..Based on our evaluation, the vaccination coverage rate was 77.9% for all included patients. However, the rate of booster doses was relatively low, at 42.0%. Reports from China also indicated that about the half of the population have received three doses of the vaccineIt was also worth noting that both the baseline demographics and the clinical characteristics were not significantly different between asymptomatic and mild symptomatic individuals. Further, Cox regression analysis confirmed that the symptomatic status was not a risk factor for prolonged duration of SARS‐CoV‐2 RNA‐negative conversion. Thus, our results suggested that symptomatic status was not associated with major clinical characteristics like the duration of viral shedding in non‐severe patients of Omicron BA.2.2 infection. We speculate that the above conclusion could be partially explained by the indistinguishable difference in viral dynamic between mild symptomatic and asymptomatic patients, which was also reported in previous study.In our study, univariate analysis results showed that chronic comorbidities were a risk factor for prolonged viral shedding duration, but no significant difference was found in the multivariate Cox analysis. In addition, it was demonstrated that old age is an independent risk factor associated with prolonged viral shedding duration, which was in line with previous studies.In the context of the vaccination strategy adopted until March 2022, it was estimated that the introduction of the Omicron variant would overwhelm the healthcare system with an estimated burden of 15.6 times the available intensive care unit capacity.Our study had some limitations. First, the variables included in our study are limited due to its retrospective nature. Some variables, such as body mass index, laboratory tests, imaging examinations, and some risk factors associated with respiratory tract infections were not included in the database. Therefore, our findings need to be confirmed in cohorts that have more detailed variables included. Second, the study only compared the characteristics of asymptomatic and mild symptomatic COVID‐19 patients. Previous study showed that significant differences were identified between mild and more severe patients.In conclusion, asymptomatic and symptomatic patients with nonsevere SARS‐CoV‐2 Omicron BA.2.2 variant infection have similar clinical features and virological courses. Symptomatic status was not associated with the clinical characteristics such as the duration of viral shedding in asymptomatic and mild symptomatic patients of Omicron BA.2.2 infection. Old age was identified as an independent risk factor for prolonged SARS‐CoV‐2 conversion time. A better understanding of the clinical and virological features of the Omicron BA.2.2 subvariant infected individuals using our data could provide valuable insights for dealing with the ongoing Omicron‐predominant COVID‐19 pandemic.Conception and design: Zhangqian Chen. Acquisition of data: Zhangqian Chen, Liangliang Wang, and Xiaoyu Kang. Analyses and interpretation of data: Lin Zhang, Xiaoyu Kang, Liangliang Wang, and Rui Yan. Critical revision of the manuscript for important intellectual content: Xiaoyu Kang and Yanglin Pan. Administrative and material support: Jiuping Wang. Final approval of the version submitted: all authors. All authors read and approved the final manuscript.The authors declare no conflict of interest.Supporting Information.Click here for additional data file.Supporting Information.Click here for additional data file.Supporting Information.Click here for additional data file.


The increased effectiveness of antiretroviral therapy (ART) in the last 30 years is a scientific landmark, and viral suppression is directly associated with treatment adherence. The aim of this study was to compare the results of ART adherence and viral load suppression with the evolution of the protocols and other associated factors, in people living with HIV. A panel analysis of three descriptive longitudinal studies investigating ART adherence and viral load suppression was conducted in people with HIV treated at a drug dispensing unit in the Federal District. The studies were carried out during periods of 2011, 2013, and 2017, coinciding with the three different recommended treatment schemes for the country. Adherence was assessed using drug dispensing records. Viral load data were obtained from the Ministry of Healthʼs Laboratory Examination Information System. Analysis of the data of 522 individuals in the three periods showed sociodemographic differences such as a decline in the percentage of women (from 33% in period 1 to 4% in period 3) and an increase in the percentage of young people. ART adherence was higher in period 2 (tenofovir/lamivudine/efavirenz scheme). Viral load suppression was greater in period 3 (tenofovir/lamivudine/dolutegravir scheme). The relative detectable viral load risk was nearly two-fold higher (RR 1.83) in people living with HIV with less than 80% adherence when compared to those above 80%. With respect to the different schemes recommended in Brazil during the periods studied, ART containing dolutegravir was the most effective in achieving viral load suppression. By contrast, there was better ART adherence in the daily combined fixed dose consisting of tenofovir/lamivudine/efavirenz in tablet form. Adherence to ART above 80% seemed to be enough to promote an effective treatment in therapeutic schemes including efavirenz or dolutegravir. Since 1996, Brazilian Ministry of Health Law 9.313/96  has guarOn average, 40,000 new HIV/AIDS cases have been recorded every year since 2011. In the Federal District (DF), 10,735 cases  were reported between the first notification of the disease in 1985 and December 2017. In 2017 alone 645 new cases were recorded, a significant increase compared to previous years .The increase in ART effectiveness against HIV infection in the last 30 years is a landmark for global science, transforming a highly lethal acute disease into a chronic condition, with a reduction in viral transmission both congenitally and through sexual contact, over a short time period. The success of ART in suppressing viral replication, however, is directly associated with patient adherence to treatment .Treatment adherence is a dynamic multifactorial process involving the behavior of PLHIV, according to the treatment indicated by the health professional, using the drugs at specified doses and times, undergoing laboratory tests and periodically accessing specialized health services . The extStudies demonstrate that there is no statistically significant difference in the likelihood of virological failure between PLHIV who achieve 95%–100% adherence and those with 80%–95%, suggesting that even the latter can suppress viral replication and not develop ART resistance .The aim of the present study was to compare treatment adherence and viral load (VL) suppression with the evolution of the protocols and other associated factors in PLHIV who received ART at a DDU in the DF and participated in longitudinal studies conducted in three different guideline periods for the care of adults infected by HIV.This is a panel analysis of three descriptive longitudinal studies carried out at different times at the Teaching Pharmacy of the Hospital Universitário de Brasilia (TP-HUB), a DDU specialized in treating PLHIV in the DF .The three databases used in the study sample were classified according to the recommendation or protocol in effect at the time of the research .+ count < 200 cel/mm³, but treatment for asymptomatic cases and CD4+ between 350 and 200 cel/mm³ could also be considered. The first-line drugs were zidovudine, lamivudine and efavirenz (AZT/3TC + EFZ), dispensed in separate “2 in 1” + 1 tablets , the presence of neoplasia or high-risk cardiovascular diseases, but already recommended the early application of ART  for Managing HIV Infection in Adults of 2013 established ART for people with CD4n of ART . First-l+ levels or other clinical conditions based on evidence of treatment as prevention (TasP)  .It is important to describe the characteristics of each treatment for adults with HIV/AIDS at the different times in Brazil:The common inclusion criteria in the three studies were PLHIV aged 18 years or older, treated at the HUB outpatient clinic and who underwent ART at TP-HUB. The exclusion criteria in the periods studied were pregnant women, <18 years old, people who used ART as prophylaxis, PLHIV who died before 60 days of treatment, stopped taking medication before 60 days of treatment, had initiated treatment less than 60 days before, whose medical records were not found and duplicate records. In the period 2 and 3 studies, patients at the onset of treatment were selected. Period 1 included PLHIV undergoing treatment initiated at any time. Participants are exclusive to each study and do not take part in the others.In order to measure adherence, all the studies used drug dispensing records obtained from the Logistics Drug Control System (SICLOM) in the operational mode. This information system is part of the Ministry of Health’s strategies for managing HIV/AIDS in the country, in conjunction with the Laboratory Examination Control System (SISCEL), where viral load (VL) data were obtained.The calculation and classification of the dependent variable ART adherence, for periods 1, 2, and 3, were redone for standardization purposes. Adherence was calculated using the pharmacy dispensing records, which have been used by several authors to assess adherence over 12 months or 12 dispensations .Based on these data, adherence was classified, according to the literature, as optimal , good (between 80 and less than 95%) and low (less than 80%) . For purThe dependent variable final VL was extracted from the SISCEL after 6 months (± 30 days) of treatment and stratified as not detectable (ND) for those with fewer than 50; 50 to 1,000; 1,000 to 100,000; and >100,000 copies/mL. For purposes of the statistical analysis of relative risk, the final VL was dichotomized and categorized as ND (<50 copies/mL) or detectable (≥ 50 copies/mL).The common independent variables in the three periods were sex, age (in years during each period), initial ART therapeutic scheme, treatment time (days), and number of treatment changes . Initially, all the database variables were analyzed by descriptive statistics . The continuous variables were subsequently categorized into ranges and categorical variables described as frequencies and percentages.For the continuous independent variable initial VL, the same stratification as final VL was used. There were no diagnostic data records for 28% of PLHIV, on either medical charts or the SISCEL database.p-values less than 5% (p < 0.05) were considered significant. The databases were structured in the Microsoft Excel® program. Statistical analyses were carried out using the SPSS® program , IBM, version 20.0.After normal distribution asymmetry and homogeneity in only two variables  was determined in each database , Pearson’s chi-squared and Fisher’s Exact tests were conducted to analyze factors associated with the variables of interest. Analyses included relative risk and its respective confidence intervals (95% CI). The Mann-Whitney test was applied to identify the correlated variables. The composition of the three databases used in the study is presented in The 522 PLHIV included a majority (75.1%) of men, with an average age of 40.6 years (standard deviation of 10.8 years), as shown in The highest percentage of VL suppression (88.9%) occurred in period 3 . This vap = 0.031). There was greater adherence in women, but lower for those aged between 18 and 29 and 40–49 years  and higher in those with initial VR values less than 100,000 copies/mL (p = 0.01) and individuals with optimal (>95%) and good (80%–95%) treatment adherence (p= <0.001). It is important to note that PLHIV with low adherence (<80%) exhibited a nearly two-fold higher risk of not suppressing VL  compared to those with optimal and good adherence (above 80%). The 18-29-year age group exhibited a higher percentage of detectable final VL . This change in the profile of new PLHIV is attracting attention in HIV/AIDS treatment adherence studies, especially in adolescents and young people in peripheral areas, due to the risks that these age groups are exposed to, such as social vulnerability, injectable drug sharing, and unprotected sex, among others . In addiOver time, there has been a change in the clinical profile of PLHIV who use ART in Brazil, according to each new guideline adopted by the Ministry of Health. In terms of therapeutic schemes, in periods 2 and 3, the preferential scheme was the inclusion criteria, as determined by PCDT-2013 and its update in 2017. In period 1, in addition to PLHIV in previous treatment, the 2008 recommendation did not mandate ART as the recommended scheme or justify ART changes on the Drug Request Form, as occurred after PCDT-2013, which explains the low percentage of the preferential scheme during this period .There was better ART adherence in period 2 (92.4%) than in the other periods. Our results demonstrated that introducing a combined fixed dose, such as tenofovir, lamivudine and efavirenz (TDF/3TC/EFZ), administered once a day, improved adherence. As reported in the literature, simpler dosing schemes, with fewer administrations and unique dosage forms favor adherence . FurtherViral load suppression was higher in period 3 (88.9%), despite its lower adherence rate in relation to the other periods. One of the main changes in PCDT-2017 was replacing EFZ with dolutegravir (DTG) in the preferential scheme for initial treatment of PLHIV or in cases of people with EFZ-related adverse reactions . The resAlso significant was the relation between viral suppression for PLHIV and initial VL up to 100,000 copies and treatment adherence. PCDT-2017 recommended that ART be prescribed as soon as HIV is diagnosed. This recommendation was based on evidence that viral suppression is faster with early treatment . The “noStudy limitations include the fact that around 30% of participating PLHIV had no VL registered in SISCEL, after the onset of ART, which may have produced biased results. Some of the individuals may have undergone examinations in private laboratories and these data were not included in SISCEL, which may compromise future research on strategic public health measures for PLHIV . AdherenAdherence is an important factor in achieving effective treatment for chronic conditions, such as HIV/AIDS. Simplified therapeutic schemes consisting of a combined fixed single tablet dose, such as in the TDF/3TC/EFZ scheme used in the second period of the study, favor treatment adherence. However, despite the lower adherence (>80%), treatments containing dolutegravir seem to promote and maintain viral suppression in around 90% of PLHIV. Based on these results, adherence above 80% achieves effective viral suppression in therapeutic schemes involving efavirenz and dolutegravir.


Antiretroviral therapy (ART) prolongs lifespan and decreases mortality of HIV infected patients. However, many patients do not achieve optimal immune reconstitution. The influence of non-optimal immune recovery on non-AIDS related diseases is not well defined in aged HIV-infected patients receiving ART.A retrospective study was conducted at Tianjin Second People’s Hospital, China to evaluate the association of an inadequate immunological response and non-AIDS diseases in HIV infected patients ≥60 years of age and virally suppressed for at least 2 years by ART.n = 666) who initiated ART between August 2009 and December 2020. The prevalence of patients with an inadequate immunological response was 29.6%. The percentage of non-AIDS diseases such as hypertension, cardiovascular disease (CVD), diabetes, tumor, and chronic kidney disease (CKD) was 32.9, 9.9, 31, 4.1, and 13%, respectively. In addition to baseline CD4+ T cell counts, CVD and tumor were associated with poor immune reconstitution in aged Chinese HIV-1 infected patients. The adjusted odds ratios  were AOR 2.45 (95% CI: 1.22–4.93) and 3.06 . Inadequate immunological response was associated with greater mortality  in this cohort.The study included patients (These results tend to demonstrate appropriate drug selection at ART initiation and prevention of non-AIDS complications during ART decreased mortality of and an inadequate immunological response in aged HIV infected patients. Antiretroviral therapy (ART) effectively controls HIV replication, increasing CD4+ T counts, and decreasing mortality. However, 9–40% of patients living with HIV (PLWH) fail to achieve CD4+ T cell count normalization and are referred to as “inadequate immunological responders,” (INRs) . AlthougART has improved patient lifespan and changed HIV from a life-threatening illness to a chronic one. As a result, the number of aged HIV infected patients has increased. Aged HIV infected patients receiving ART have a reduced immune response , 7. At s. However, UNAIDS records PLWH aged 50 or over need provide appropriate prevention and demand age-appropriate health services , loss to follow-up (30), ART time less than 2 years (92), and virologic failure (8). Data for 507 PLWH comprised the final study group. Of the 507 individuals, 150 patients had CD4 + T cell counts less than 350 cells/ml. A flow chart of patient characteristics and selection is presented in 2); tumor ; diabetes (history of diabetes); hypertension (history of hypertension), INRs . Immunological responders . HIV virologic failure was defined as two consecutive measurements with HIV RNA > 200 copies/ml after 6 months of ART.CVD ; chronic renal disease, CKD  were investigated as risk factors. A p value <0.05 was considered statistically significant.Statistical analysis was performed using SPSS 25.0 software  and GraphPad 8 . Because of skewed statistical distributions, numerical data are presented as medians with interquartile ranges (IQR); categorical variables are presented as percentages. Differences between two groups were analyzed using the Mann–Whitney U test (nonparametric). Logistic regression and Cox proportional regression models were used to evaluate risk factors associated with poor immune reconstitution after 2 years of ART, and mortality. Kaplan–Meier curves were computed for this cohort. Log-rank testing was carried out to evaluate differences in cumulative death in HIV-infected patients, with or without INR. Demographic variables  and clinical/laboratory characteristics , greater percentage of CVD , and a greater death ratio (13.1% vs. 4.2%). All descriptive statistics for study variables are presented in A total of 507 aged PLWH were included in the analysis. Of these 150 (29.6%) had poor CD4 + T cell recovery (INR). The median age was 63 , and the male to female ratio was 8.45:1. Twenty-three (4.5%) were co-infected with HBV, six (1.2%) were co-infected with HCV. The median BMI was 23.4 , the median CD4 T+ cell count at baseline was 188  cells/μl. The percentages of non-AIDS associated diseases are shown in p = 0.01), tumor , baseline CD4+ T cell counts 50–199 cells/μl , and CD4+ T cells counts <50 cells/μl . Associations with decreased probability of poor CD4+ T cell recovery were protease inhibitor (PI) based  and integrase strand transfer inhibitor (INSTI) based , The multivariate logistic regression model found the following associations with poor immune reconstitution in elderly Chinese HIV-1 infected patients. These were; CVD (adjusted odds ratio (AOR): 2.45, 95% confidence interval (CI): 1.22–4.93, n = 1, anal cancer n = 2, lung cancer n = 2, stomach cancer n = 2, pancreatic cancer n = 1, leukemia n = 1, cholangiocarcinoma n = 1, and unidentified cancer n = 2), CVD (n = 11), opportunistic infections (OIs) (n = 7) . Among these, OIs were only found in the INR group. Log-rank testing showed a significant difference between patients with and without CVD (p < 0.001), INR (p < 0.001), and tumor (p < 0.001).Thirty-eight (7.6%) patients died during 3,547 person-years of follow-up. The main causes of death were; tumor (12) , tumor , INR , and older age . Change in ART drugs during ART  was associated with decreased mortality  aged PLWH were INR, which is consistent with a previous study . Aged INAlthough ART has reduced worldwide HIV related mortality and morbidity, INR patients with virologic suppression still have a greater probability of poor outcomes and no obvious CD4+ T cell recovery. Baseline CD4+ T cell counts, advanced age, co-infection with HCV, thymic dysfunction, immune activation, and genetic factors contribute to poor immune recovery , 14. By Persistent inflammation and immune activation exacerbate tissue damage in PLWH, increasing the risk for non-AIDS-related co-morbidities that are commonly observed in PLWH and advanced age . FurtherHypertension was found in 33.1% of all patients in this study, which is greater (33.1% vs. 30.3%) than rates reported for the IPEC/FIOCRUZ cohort. In this study, there was a greater prevalence of diabetes among elderly patients (31% vs. 4.6%) compared to the IPEC/FIOCRUZ cohort, which was also greater than rates observed for the Chinese general population  . GeneticIn a previous study the main risks for death in patients receiving ART have changed from OIS to non-AIDS-defining malignancies and CVD , 19. ForPrevious studies found that death risk for patients receiving continuous ART with CD4+ T cell counts >500 cells/μl was similar to patients with full immune recovery. INRs have twice the number fatal and non-fatal non-AIDS diseases compared to IRs , 21. In Treatment option at ART initiation for INR patients are still debated. INSTI-based was confirmed a faster viral load suppression and immune recovery than PI-based regimens after ART in early HIV infection . AnotherThere are limitations to this study. First, the inherent bias of a retrospectively designed study is a limitation. Second, the initiation and diagnosis of non-AIDS related diseases was not adequately recorded in the patients’ medical records. Third, data were only derived from the Tianjin HIV tertiary health center. Future studies should examine the effects of non-AIDS diseases on immune recovery of patients similar to those investigated by this study.In conclusion, this study identifies the risk factors for poor immune recovery of aged HIV infected patients. Baseline CD4+ T cell counts, CVD, tumor, and initial ART drug are strongly associated with poor immune recovery. Greater mortality and a greater risk for INR in an aged population argues for close monitoring of ART treatment effects and non-AIDS complication during ART. Switching ART drugs during treatment was associated with lower mortality rates, therefore, the initial treatment selection might affect mortality rates. Immune reconstitution differences after ART drug initiation demonstrate drug selection to be important for aged patients. Further research is needed to determine whether alterations in ART drug selection would improve immune reconstitution and better clinical outcomes.The original contributions presented in the study are included in the article/The studies involving humans were approved by Medical Ethics committee of Tianjin Second People’s Hospital Approval certificate of Ethical Review [2020]49. The studies were conducted in accordance with the local legislation and institutional requirements. The participants provided their written informed consent to participate in this study.LF: Data curation, Formal analysis, Methodology, Writing – original draft. PL: Data curation, Validation, Formal analysis, Investigation, Writing – original draft. AY: Data curation, Investigation, Supervision, Writing – original draft. DL: Data curation, Methodology, Writing – original draft. ZW: Data curation, Writing – original draft. YW: Data curation, Writing – original draft. DZ: Data curation, Writing – original draft. MZ: Writing – original draft, Supervision, Validation. PM: Writing – original draft, Funding acquisition, Project administration.


Any patient with a VL of > 50 copies/mm3 requires enhanced adherence support with VL monitoring. When a patient has met the criteria for virological failure, defined as two consecutive VLs > 1000 copies/mm3, resistance testing is recommended, under specific conditions.8 These conditions include: previous confirmed ART regimen failure ; at least two years on TLD; and adherence of > 80% by objective measurement. If a client is on TLD with no record of ART failure (known as TLD1), resistance testing is only indicated in special circumstances.8Several studies have shown that even with pre-existing nucleoside reverse transcriptase inhibitor (NRTI) resistance, switching to DTG, while maintaining the same NRTI backbone, achieves viral suppression rates of over 90%.9 A recent article also described South Africa’s first published case of DTG resistance, in a treatment-experienced, integrase strand inhibitor (InSTI)-naïve adolescent.10However, within programmatic settings, reports of DTG resistance are emerging, including a 5.8% rate of DTG-resistant mutations among adolescents and young adults in a Tanzanian national survey.11 Between 2010 and 2022, implementation of VTP has led to a dramatic 58% decline in new HIV infections among children under five years of age.12 In South Africa, the most recent vertical transmission rate at 18 months of age is 4.3%.11 The roll-out of DTG has offered hope for further reducing vertical transmission, since the time to viral suppression is approximately halved by DTG when compared to the previously preferred first-line antiretroviral, efavirenz (EFV).13 Emerging DTG resistance will pose challenges to effective VTP. With increased frequency of resistance, there is increased risk for adverse maternal outcomes and vertical transmission of resistant HIV. Managing infants who acquire a resistant virus can be especially difficult given limited access to more tolerable and effective ART options for paediatric populations.The use of antiretroviral drugs that rapidly and safely achieve and sustain maternal viral suppression during pregnancy and breastfeeding is essential for vertical transmission prevention (VTP).To our knowledge, this is the first clinical case series describing confirmed DTG resistance in PBFW in a programmatic setting.Each patient included in this case series was managed directly by two of the authors, Fourie and Davies, within advanced clinical care or higher risk pregnancy clinics. The patients provided written consent to be included in the case series. A full file review, extensive search of the National Health Laboratory Services (NHLS) test results database, review of pharmacy ART pick-ups, and in-depth interviews with each woman were conducted.3, she developed first-line virological failure and was switched to lamivudine/abacavir/lopinavir/ritonavir. She experienced poor adherence and a seven-month treatment interruption between January 2020 and July 2020, following a bereavement and subsequent depression. After re-engaging in August 2020, she did not achieve viral suppression. In September 2021, with a VL of 91 600 copies/mm3  and HIV in 2012. In 2018, with a CD4 count of 6 cells/mm3 (log 5.2). Throughout the pregnancy, she reported improved adherence, with no missed doses, vomiting, or drug-drug interactions. Despite this, repeat VLs remained > 1000 copies/mm3. At 22 weeks’ gestation, after 17 months on a DTG-based regimen, HIV drug resistance testing confirmed high-level DTG resistance (3 (log 2.2). She was advised to exclusively formula feed and lamivudine/zidovudine/nevirapine infant prophylaxis was provided for six weeks. Both birth and 10-week infant HIV polymerase chain reaction (PCR) tests were HIV–negative.In November 2022, at nine weeks’ gestation, she attended her first antenatal care (ANC) visit for an unplanned pregnancy and had a VL of 169 000 copies/mmsistance . At 27 w3 .In February 2020, Case 2, a 34-year-old woman, presented with an unplanned pregnancy at 22 weeks’ gestation and was newly diagnosed, by self-report, with HIV. She delivered before ART initiation in May 2020, with a VL of 223 000 copies/mmlog 5.4; . The inf3 (log 5.4). In September 2022, a second unplanned pregnancy was confirmed at 23 weeks’ gestation. Responding to the unsuppressed VL of 43 500 copies/mm3 (log 4.7), she was switched to zidovudine/lamivudine/DTG. She was then referred to an advanced clinical care clinic where multiple adherence issues were identified and addressed, and she was switched to TLD.The next VL in February 2022, was 225 000 copies/mmThroughout this pregnancy, and beyond delivery, despite improved adherence of > 80% based on regular clinic attendance, pharmacy refills, and an adequate DTG blood level of 0.979 µg/mL, VLs remained unsuppressed.3 (log 5.1), she was advised to wean her infant; zidovudine/nevirapine infant prophylaxis was restarted, and resistance testing confirmed high-level DTG resistance .Only after receiving resistance results did Case 2 disclose additional ART experience prior to 2020, with low adherence and multiple treatment interruptions. A retrospective search of the NHLS database at this point confirmed the prior history. Case 2 reported being initiated on a single daily pill which, based on guidelines from that time, would have most likely been tenofovir/emtricitabine/efavirenz (TEE). Between 2015 and 2020 she reported multiple interruptions but no change in regimen, and VLs from that period were never suppressed. She was switched to tenofovir/emtricitabine/darunavir/ritonavir in June 2023. A repeat VL in September 2023 was < 20 copies/mm3. As well as TB, she had active cytomegalovirus (CMV) infection and herpes simplex virus (HSV)-1 and -2 serology was positive. The authors did not have access to the admission record to confirm whether she received treatment for these two conditions. During TB treatment, DTG was prescribed once-daily, in contradiction to guidelines requiring boosted DTG through 12-hourly dosing to compensate for rifampicin-DTG drug-drug interaction.In December 2020, Case 3, a 35-year-old woman, was admitted with newly diagnosed TB and HIV. Her new HIV diagnosis was confirmed through a thorough search of the NHLS database, as well as a blood donor card indicating her last recorded donation in late 2018. TLD was initiated two weeks after TB treatment. She was critically ill, with a CD4 count of 2 cells/mm3 (log 3.1) and 190 335 copies/mm3 (log 5.3) (3 (log 2.4).Despite being ART naïve, with > 80% adherence (confirmed through regular clinic attendance and pharmacy refills) her VLs remained between 1300 copies/mmlog 5.3) , from Ju3 (log 3.4), and CD4 count 318 cells/mm3. During her pregnancy she vomited most mornings but continued taking TLD at night. Resistance testing was ordered at 27 weeks’ gestation and DTG resistance was confirmed at 29 weeks (3 (log 1.7) and at delivery was 25 copies/mm3 (log 1.4). The infant had a negative HIV PCR at birth, was exclusively breastfed, and was provided with zidovudine/nevirapine infant prophylaxis cover.In May 2023, she attended ANC with an unplanned pregnancy at 26 weeks’ gestation. Her VL was 2 790 copies/mm29 weeks , promptiWe have described the first reported cases of DTG resistance in PBFW in the South African ART programme. In all cases, there were intensified clinical support during antenatal and postnatal care, and vertical transmission of HIV was prevented.14 One possible reason for Case 3 developing DTG resistance may have been her very high rate of viral replication at ART initiation, with a baseline VL of 5 040 000 copies/mm3 (log 6.7), in combination with a very low CD4 count.15 Furthermore it is possible that, although she had good support following discharge from hospital, she had suboptimal adherence due to being very unwell and having a significant pill burden.In Cases 1 and 2, suboptimal adherence, failure to screen, diagnose and refer for mental health support, poor clinical management of high VLs over prolonged periods, as well as previous ART exposure were likely driving factors for resistance. In Case 3, the lack of DTG boosting during TB treatment is the only identified cause. This is an important observation considering the RADIANT-TB  trial reported no significant difference in viral suppression or resistance when DTG was ‘unboosted’ during TB treatment.16 One survey among pregnant women in South Africa in 2019 showed a 51.5% prevalence of unintended pregnancies in women living with HIV and engaged in care.17 It is important to note that all three cases presented with unplanned pregnancies, with Case 2 having two unplanned pregnancies within two years, highlighting an ongoing failure of the South African ART programme to effectively integrate contraceptive services into HIV services for women of reproductive age. Effective integration of reproductive health services with HIV services is particularly important for women experiencing advanced HIV disease and/or unsuppressed VLs because vertical transmission risks are elevated in the context of suboptimal maternal health.One of the cornerstones of comprehensive VTP programmes is avoiding unintended pregnancies in women living with HIV.19 Two of the three cases reported longstanding mental health and psychosocial challenges that persistently undermined their ability to adhere well to their ART regimens and remained unaddressed during years of routine care. This emphasises the importance of integrating psychosocial and mental health support into HIV services. In particular, better integration into antenatal and postnatal care remains a key component of supporting PBFW to achieve and maintain viral suppression during their VTP journey.Several key factors influencing ART adherence and VL suppression are well documented in the literature, including medication side effects and pill burden, substance use, presence or lack of social support, comorbid mental health conditions, and duration on treatment.20 It is noteworthy that Case 2 re-engaged with each pregnancy, a common pattern of re-engagement among female patients.21 Unfortunately, with increasing reports of DTG resistance,10 clinicians in South Africa need to be aware that, although DTG is robust, resistance remains a possibility in a small proportion of individuals. This case series adds to the evidence raising concerns that in programmatic settings, DTG resistance may be more frequent than predicted, particularly in contexts where inadequate adherence support and VL monitoring result in prolonged periods of viral non-suppression.These cases demonstrate the difficulties encountered in high-HIV-burden settings, even with supportive clinical and counselling relationships, in achieving full, open discussions about prior ART history, adherence patterns, and other medication use. In the South African public healthcare setting, some information required to satisfy resistance testing criteria can also be complicated to ascertain. Reasons include gaps in the health information systems, including the lack of a universal unique patient identifier. Persons living with HIV also fear stigmatisation upon disclosing treatment interruption. Consequently, patients, like Case 2, often preferentially re-engage as new patients via repeat HIV testing.Because DTG has a high resistance barrier, the current South African ART guidelines focus on addressing adherence issues in unsuppressed individuals and provide strict resistance testing criteria. The managing clinicians in these cases, although fully aware of the current guidelines, had specific concerns related to the risk of vertical transmission and used clinical judgement to proceed with drug resistance testing, despite the cases not meeting all the criteria. Strict adherence to the time on ART and previous ART failure (classified as TLD2) criteria for resistance testing, would have delayed identification of resistance, potentially leading to vertical transmission.Acknowledging the limitations of a case series, including anecdotal fallacy and lack of generalisability, the authors recommend the following:15 All our cases had at least one VL above 100 000 copies/mm3 and CD4 < 200 cells/mm3 at some point during treatment. Criteria may need to be reviewed for individuals with CD4 < 200 cells/mm3 or VLs above 100 000 copies/mm3.Resistance testing criteria may need to be more flexible, particularly for pregnant and breastfeeding patients. Poor treatment adherence, low CD4 count and high VL at DTG initiation or switch, and drug-drug interactions, are all risk factors for integrase resistance.22Enhanced programmatic DTG resistance surveillance, considering the high number of individuals in the South African ART programme with suboptimal adherence, low CD4 counts and/or high VL at DTG initiation or switch, or with drug-drug interactions.23A thorough review of evidence including programmatic data regarding the use of boosted DTG during TB treatment is needed before any future updates are made to clinical guidelines, including antiretroviral and TB guidelines, based on the findings of the RADIANT-TB trial. We agree with Catteano & Gervasoni that the dose of DTG should be doubled when used with rifampicin, particularly in patients with high VLs.Improved integration of contraceptive services within the ART programme, with a particular focus on women with unsuppressed VLs and/or advanced HIV disease.Inclusion of mental health screening and support for all patients with adherence challenges or treatment interruptions.While InSTI resistance occurred rarely in clinical trials, it may become more prevalent than anticipated in programmatic settings, especially where adherence and retention support is insufficient. These cases highlight that despite DTG’s high resistance barrier, individuals will still experience resistance. Clinicians should remain alert to the possibility of DTG resistance and programmatic surveillance should be strengthened.


Managing multidrug-resistant (MDR) HIV infections in children is particularly challenging due to the lack of experience with new drugs in the pediatric setting. Second-line albuvirtide (ABT) with an optimized antiretroviral background therapy was approved for adults and adolescents after first-line treatment failure. This paper describes the treatment outcomes and adverse effects of an ABT-based dual-active antiretroviral treatment regimen in a child with MDR HIV strains.A 13 year-old Chinese female patient infected with MDR HIV strains showed a decrease in viral load (from 4.48 log10 to 1.73 log10) and an increase in CD4 + T cells (from 15 to 308 cells/µl) after 12 months of treatment with an ABT-based antiretroviral regimen. The child showed no relevant drug-related adverse reactions.The case reported here could suggest that an ABT-based antiretroviral therapy might be beneficial and without relevant toxicity in children with MDR HIV. Infectiologists specializing in managing HIV should be prepared to manage an increasing number of children with MDR HIV. ABT might be a new treatment option for MDR HIV infection in children. HIV/AIDS is a major public health concern, with 38.0 million people living with HIV infection in 2020, including 2.78 million children (< 19 years of age) [Children with HIV will require life-long and long-term therapy, increasing the risk of developing HIV drug resistance (HIVDR) due to inadequate drug compliance, the lack of evidence-based data regarding specific ART dosing in different age groups, and suboptimal regimens or plasma drug levels. Children have higher rates of HIVDR than adults with heterosexually transmitted HIV and have a 2.2-fold higher risk of virological failure (VF) than adults after 5 years of ART .Albuvirtide (ABT) is a long-acting injectable ART approved by the Chinese National Medical Products Administration (NMPA) in 2018 and has broad-spectrum anti-HIV-1 activity in vitro, with a half-maximal inhibitory concentration (IC50) of 0.5-5.0 nmol/l.Herein, we report a 13-year-old Chinese female child with AIDS and MDR and the treatment effect and adverse effects of an ABT-based active antiretroviral treatment regimen that is the first case report in the world.A 13 year-old female child with HIV progressed to AIDS despite treatments and was admitted to the First Hospital in Changsha in June 2020. She was infected through MTCT, and her parents both died of AIDS. At admission, her legal guardians reported persistent cough with white sputum, nausea, vomiting, and weight loss for 4 months.The patient was infected with HIV at birth, and her parents died of AIDS many years ago. She was diagnosed with HIV infection at 1 year of age but started ART at 6 years old. The initial ART regimen was unclear before 2016, till she started the 3TC/ABC/LPV/r regimen.Pneumocystis pneumonia (PCP), and fluconazole was given as an empirical antifungal treatment. She continued the previous ART regimen of 3TC/ABC/LPV/r. The patient recovered and was discharged after 20 days of treatment.At admission, the viral load and CD4 + T-cell counts were 6.16 log10 copies/mL and 2 cells/µl, respectively. AIDS, along with an opportunistic infection, was diagnosed. Sulfanilamide was given against In August 2020, the viral load and CD4 + T cell counts were 4.48 log10 copies/mL and 15 cells/µl, respectively, and an MDR test (Sanger sequencing) detected 15 point mutations in the reverse transcriptase  and protease  (Table In July 2021, the HIV viral load was decreased to 1.73 log10 copies/mL, and the CD4 + T-cell count was increased to 308 cells/µl (Fig. The patient ultimately developed classical Hodgkin lymphoma in January 2022. Unfortunately, due to the foster family’s economic condition, poor family care, medication non-compliance, and a low desire for life, the patient died on March 5, 2022. The main cause of death was Hodgkin lymphoma.Children infected with HIV via vertical transmission will eventually develop significant HIV MDR due to low doses of non-suppressive regimens and/or inadequate ART adherence . Data frThe patient reported here was infected through MTCT, and her parents died of AIDS. She had an incomplete adherence to ART, and the viral load was very high with low CD4 + T cell counts. Therefore, the likelihood of developing MDR was high.ABT is a long-acting HIV fusion inhibitor used in patients > 16 years of age. It is active against 28 different clinical isolates of HIV-1 in China, with IC50 values ranging from 1.3 to 18.1 nmol/L [Since DTG is effective in children > 4 weeks of age and weighing > 3 kg, the WHO recommends the ABC + 3TC + DTG combination as the preferred first-line regimen for children. Nevertheless, DTG monotherapy was associated with an increased risk of virological failure and DTG resistance in adults. Furthermore, the case reported here showed MDR to protease inhibitors, NRTIs, and NNRTIs. Therefore, a combination of ABT and DTG was used, the viral load was decreased, and the CD4 + T cells count was increased after 4 weeks. After 1 year, the viral load was maintained at low levels. Before switching to an ABT-based regimen, the child demonstrated a depletion of CD4 + T cells, but CD4 + T-cell recovery to 308 cells/µl was observed after ABT + DTG treatment. A sufficient CD4 + response with ART was evidenced as 50–150 cells/µl .In the patient reported here, the HIV RNA was 54 copies/mL but did not achieve < 20 copies/mL virologic suppression. High pre-treatment HIV-RNA levels are an independent predictor of delayed virological suppression and increased risk of virological failure , 9. UnfoIn conclusion, this is the first reported case of the use of ABT in a child with virological failure. Furthermore, it provided information on the use of ABT in a child with MDR HIV and showed good effectiveness and safety for nearly 1 year.


Background: In India, following the implementation of the dolutegravir (DTG) based regimen, only a few studies compared the outcomes of DTG and efavirenz (EFV) based regimens. Therefore, this study aimed to assess virological suppression and gain in CD4+ counts of DTG and EFV-based antiretroviral therapy (ART) regimens.Methods: A retrospective study was conducted and the entire sample (n=140) was divided into two major classes as DTG group (n=70) and EFV group (n=70) further classified as tenofovir/lamivudine/dolutegravir (TLD) and tenofovir/lamivudine/efavirenz (TLE) regimen. Data was collected on socio-demographic characteristics, laboratory measures, and clinical and drug-related variables. For quantitative and qualitative data analysis, respectively, the T-tests and Chi-square tests were applied.Results: The mean CD4+ gain was comparable in both regimens after six months of ART but significant after 12 months of ART in the TLD group. Viral load suppression was achieved in 55.71% of clients in the TLE group after six months of ART while in the TLD group, 88.57% of clients achieved virologic suppression which was highly significant. Clients who remained on the DTG-based regimen gained significantly more weight at 12 months (mean +6.15 kg) as compared to the EFV-based regimen (mean +1.85 kg). After 12 months of ART, the majority of laboratory variables were unaffected by either regimen with the exception of serum creatinine and random blood sugar (RBS) in the TLD group.Conclusions: Our study provides real-life evidence of better outcomes of therapy with DTG over EFV in terms of viral load suppression but immunologic recovery is equivalent in EFV-based regimens after six months of treatment. We recommend the use of DTG only in clients with a high baseline viral load as it costs approximately twice as much as EFV when cost-effectiveness is taken into account. Human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) is a public health problem that has claimed more than 38 million life until 2021 globally ,5. The EBy 2019, the WHO recommended transitioning to DTG-based first-line regimens as 12 out of 18 countries surveyed by the WHO reported pre-treatment drug resistance to EFV exceeding the recommended threshold of 10% . In settTwo primary goals of anti-HIV therapy are to suppress viral HIV RNA plasma replication and preserve and restore the number of circulating CD4+ T cells, the immune cells attacked by HIV. Therefore, this study is aimed to assess virological suppression and gain in CD4+ counts of DTG and EFV-based ART regimens to better understand the long-term outcomes of these combination treatment regimens.A retrospective hospital-based study was carried out at an ART center of a tertiary care hospital. Approval of the research project was obtained from Institutional Human Ethics Committee (No. MCV/IHEC/381). Additionally, approval has been obtained from the respective state AIDS Control Society. The confidentiality of reviewed patient information was maintained throughout the coding of individual patient data.Study population and study durationThe study was conducted on adult people living with HIV (PLHIV) who were on DTG and EFV-based ART regimens between October 2018 and September 2021 that fulfilled the inclusion criteria.A total of 140 client files (n=140) were eligible and reviewed. The entire sample was divided into two major classes as DTG group and the EFV group which was further classified as tenofovir/lamivudine/dolutegravir (TLD) and tenofovir/lamivudine/efavirenz (TLE) regimen. A ratio of 1:1 was applied whereby 70 clients on TLD (n=70) and 70 clients on TLE (n=70) were recruited by a simple convenient sampling method. The study was conducted for two months whereby information was extracted using a case record form (CRF).HIV-positive people who were substituted for DTG-based ART regimen from EFV-based regimen were also noted and the reasons for substitution were evaluated. Additionally, the number of clients who switched to a second-line regimen from DTG and EFV-based first-line regimens was noted.Selection criteria of people living with HIVAll treatment-naïve adult HIV-positive people (age >18 years) of either sex on DTG and EFV-based first-line regimens for at least six months, who had CD4+ counts done at baseline, six months and at one year (if done) and viral load at six months and at one year (if done), whose records were legible and complete were included in the study. Those that were transferred out/died within less than six months of follow-up and pregnant women were excluded from the study.Outcome variablesThe primary outcome was the proportion of HIV-positive people with a mean increase in CD4+ cell count from baseline to six months and one year. Virological suppression at six months and a year was the secondary endpoint.Data collectionThe CRF consisting of three parts was used in data collection. It was validated before the commencement of the study. The first part of CRF included demographic information such as sex, age, gender, weight, education, marital status, and past/personal and medical history. The second part of CRF included laboratory data, and the third part consisted of details of antiretroviral treatment which included information regarding the type of regimen initiated, the substitution of regimen (within first-line ART), switching of regimen to second-line ART, WHO clinical stage, functional status (W/A/B), CD4+ cell count, viral load, side effects, prophylaxis, and adherence rate (assessed as pill count).Statistical analysisData from the CRF was entered in the Excel sheet. A descriptive statistical study was performed and results were presented by text, tables, and charts. For quantitative and qualitative data, respectively, the T-test (paired and unpaired) and Chi-square tests were applied. The results were considered having statistical significance when P <0.05 and highly significant when P < 0.001.In our study, the mean+/-SD age of the study population was 37.56+/-11 and most of the population was within the age group of 34-45 years. The majority of the people living with HIV (PLHIV) were male (93%). Seventy percent of the PLHIV were married, and 51% had HIV-positive spouses. Only 12% of HIV-positive people were homosexual, with 76% being heterosexual, 24.29% of PLHIV had only completed primary school, and 22.14% of PLHIV were illiterate. Tuberculosis was detected in 25% of PLHIV. Alcohol, smoking, and tobacco chewing history were present in 13.57%, 9.29%, and 10.71% of PLHIV, respectively, but this information was not readily available in the majority of client files. The results are presented in Table According to the NACO recommendations, most HIV-positive people who were receiving EFV had switched to a regimen based on DTG by July 2020. There were no clients switched from the first to the second line of treatment in either regimen. The majority of the clients in our study were in a working-functional state (95.71% at baseline and 98.57% at 12 months) for both regimens.As shown in Table Viral load suppression was achieved in 55.71 % of PLHIV in the TLE group after six months of ART while in the TLD group, 88.57% of PLHIV achieved virologic suppression which was highly significant. The findings were consistent at 12 months and 95.71% of PLHIV had achieved viral load suppression as compared to 80% in the TLE group Table .Figure People living with HIV who remained on a DTG-based regimen gained significantly more weight at 12 months (mean +6.154 kg) as compared to an EFV-based regimen (mean +1.857 kg) and the difference was statistically significant. The rate of weight gain slowed in the TLE group from 6-12 months of ART treatment. The results are presented in Table The majority of laboratory parameters were unaffected by either regimen after 12 months of treatment. But after 12 months of treatment, serum creatinine value in the TLD group increased from 0.89 to 1.08 , which is likewise statistically significant. Similarly, random blood sugar (RBS) was also affected in TLD-treated PLHIV though it was within the normal range Table .In our study, a significant increase in mean CD4+ count gain was observed after 12 months of treatment in a TLD-based regimen than a TLE-based regimen. This result is in harmony with a meta-analysis done by Sonya et al. who reported that treatment with DTG resulted in a significantly greater increase in mean CD4+ cell count from baseline at week 48 than EFV . WHO conHowever, we observed that the mean CD4+ counts gained after six months in the TLE group were comparable to the TLD group. Our results suggest that although DTG produced a significantly greater increase in CD4+ T cell count than EFV, additional studies are necessary to better understand the impact of these findings. The increase in mean CD4+ count was rapid during the first six months of treatment in both regimens followed by a slight gain as people living with HIV (PLHIV) were stabilized with the therapy. A similar trend was observed in a study done in Tanzania .We found that virological suppression was significantly higher in DTG-based regimens as compared to EFV-based regimens which are supported by previous studies ,12. RuthWe observed that DTG based regimen gained significantly more weight compared to EFV based regimen across all time periods. Similar findings were observed in a study done in Tennessee, US in which DTG gained 6.0 kg weight compared to 2.6 kg for NNRTIs at 12 months (P< 0.05) . SimilarWe found that most of the laboratory parameters were not altered significantly in both ART regimens. But the rise in serum creatinine in the TLD-based ART regimen raised concern. Lianfeng Lu et al. found that DTG containing regimen presented with higher serum creatinine elevation and decreased eGFRcr . AccordiLimitations of the studyThis study was based on secondary data (data extracted from case record files) and information on adverse drug reactions and height was not available. We could not evaluate opportunistic infections as clients were directly transferred to the relevant departments depending upon the infection. P value for hemoglobin could not be assessed as prophylactic modalities, counseling, and blood transfusion (if required) was provided in case of low Hb (<9 gm/dL). It would be better if the prospective, multicentric study could be conducted in the future to confirm our findings.Our study provides real-life evidence of the superiority of DTG over EFV in terms of virological suppression in treatment-naïve PLHIV. These results further support the current WHO recommendations to initiate ART with a DTG-based regimen. According to our findings, immunologic recovery is equivalent in EFV-based regimens after six months of therapy, despite the fact that DTG produced a significantly greater increase in CD4+ count after 12 months of ART. We recommend the use of DTG only in HIV-positive with high baseline viral loads as it costs approximately twice as much as EFV when cost-effectiveness is taken into account. The change in blood glucose, serum creatinine level, and weight gain in a DTG-based regimen need to be explored further. Additional studies on a larger scale are needed to better comprehend and validate our findings.