To characterize the epidemiological profile of patients aged 50 years or older diagnosed as HIV/AIDS, in a Specialized Service of the Public Health System. A retrospective cohort study using secondary data from medical records in the period 2014 to 2018. Sociodemographic and clinical characteristics, and features related to treatment adherence were organized in a database. Quantitative variables were expressed as mean (or median) ± standard deviation (or interquartile range), and categorical variables expressed as number and percentage of patients. The Kaplan-Meier method was applied to assess the probability of overall specific survival. Of the 241 initially eligible patients, 149 patients were evaluated, registering 19 deaths in the studied period. There was a predominance of males aged 50-59 years, with severe immunodeficiency upon admission (29.7%), and with a CD4+ T lymphocyte count below 200 cells in 62 (46.3%) of patients. Elderly people aged 61 or over were more adherent. There was an increase in the CD4+ T lymphocyte count by an average of 139.63 in the first 6 months, and 50.51 from the first 6 months to 12 months of follow-up, with an average increase in the first 12 months of 157.63 cells. Specific overall survival in the period was 85%. Patients older than 50 years had an immune response and no viral load detection in the 12-month period, deserving further studies to improve survival. Instituto Brasileiro de Geografia e Estatística (IBGE) suggest the elderly population in Brazil amounts to 28 million people or about 13% of total population. Aging is associated with increased adverse health risks, particularly in groups of people living with the same disease, such as infection by the human immunodeficiency virus (HIV).Population aging is occurring rapidly all over the world and, following this trend, data from the In the 1980´s, HIV infection was considered a disease of young individuals. However, the epidemiological data changed, the virus spread significantly among the elderly, with an increasing number of older people (50-year-old and over) living with the virus. This change was due to the longer survival achieved after the advent of highly active antiretroviral therapy, turning the focus to chronic disease management. Chronologically, the WHO definition of elderly patients in developing countries is people aged 60 and over.The World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) estimate that, of the 40 million people living with HIV/AIDS in the world, approximately 7.5 million are aged 50 and over and, in the context of HIV infection, these people are considered to be elderly. This is due to characteristics of this group, usually similar to those of individuals 5 to 10 years older, because the virus accelerates aging - including aging of the immune system. Factors associated with poorer treatment evolution include a low CD4+ T cell count nadir, first diagnosis close to the age of 50 years and over, and transmission by intravenous drug use.-7The prognosis for patients initiating treatment, in the modern era of antiretroviral therapy, is excellent, with a life expectancy close to that of same-age controls.,9 have been implicated in this delayed diagnosis.Older patients are usually diagnosed at advanced stages of HIV infection, and several factors, including failure of health care professionals to suspect the disease in this population, as well infection symptoms being associated with many age-related conditions,,11 Likewise, maintenance of undetectable HIV viral load reduces the risk of sexual transmission of HIV to marginal levels, which makes preventive treatment a safe option for serodiscordant couples.Prompt diagnosis and early onset of treatment are vital, considering the immune system of older adults tends to respond slower, compared with that of younger individuals. Also, good adherence to the therapy can postpone or prevent the onset of immunodeficiency.-14 Several promoters of non-adherence to drug therapy have been described, including factors related to regimen, patient, and health system. Some factors, such as polypharmacy, alcohol and drug abuse, and depression are frequently found in older patients, and will negatively affect adherence, in addition to individual differences, even though preliminary data have pointed to a more favorable behavior.,14A current challenge has been adherence to antiretroviral system, defined as effective use of the prescribed drugs, since inappropriate or insufficient administration  contributes to emergence of resistance to drug therapy, compromising clinical outcomes.In view of the above, specific measures focusing on prevention, diagnosis and treatment adherence by older patients should be incorporated into the management of chronic infection, which is a complex and dynamic phenomenon.To identify the clinical-epidemiological profile of HIV/AIDS patients, aged 50 and over, seen at a Specialty Care Service of the Brazilian Public Health System. The prevalence of comorbidities, the level of cell immunodeficiency, adherence to treatment at month 6 and month 12, and their comparison with patients aged over and under 60 years, in addition to group mortality and survival indicators, were assessed.Unidades Dispensadoras de Medicamentos).A retrospective cohort study of adults diagnosed with HIV and AIDS at the Specialty Care Service (SAE) of the Health Surveillance Center (CVS) of the city of Juiz de Fora (MG). This outpatient facility services local patients and also those from 102 surrounding cities. The service is composed of a multidisciplinary team with infectious disease physicians, registered nurses and nurse technicians, dentists, psychologists and social workers, in addition to pharmacists from the Antiretroviral Drug Dispensing Unit  with data provided from the Municipal Epidemiological Surveillance Service.Of the 19 deaths occurring during the study period, 13 were from AIDS-related causes, three from non-AIDS-related causes, and three from unidentified causes. The vital status of patients at the end of follow-up was verified in the medical chart and through the mortality information system  and variables relative to health conditions and lifestyle , in addition to clinical characteristics .Sistema de Controle de Exames Laboratoriais) data were obtained on the CD4+ T cell counts using the FACScalibur™ Multitest flow cytometer, and HIV viral load values quantified by nucleic acid amplification using the Abbott RealTime HIV1 assay, which detects from 40 to 10 million copies. Cases of transient viremia or viral blips are defined as detection of low levels of viral RNA, typically between 50 and 200 copies.Through the Laboratory Test Control System of the National Network for CD4+/CD8+ Cell Count and HIV Viral Load Testing (SISCEL - Sistema de Controle Logístico de Medicamentos).Information on the antiretroviral drugs prescribed, as well as the number of pickups at month 6 and month 12, were retrieved from the Drug Logistics Control System , which emphasizes the importance of the CD4+ T cell count for follow-up of HIV-infected patients as follows: higher than or equal to 500cells/mm at months 6 and 12. For this purpose, an indicator was created establishing that up to five pickups at month 6 and ten pickups at month 12 would classify the patient as non-adherent.Adherence to antiretroviral therapy was estimated through verification of the frequency of monthly dispensations by the pharmacy, considering as adherent patients who used 95% of prescribed doses,2 test was used for comparison of proportions.Study data entry and analysis were organized in a database using Microsoft Excel and SPSS software, version 21. Quantitative variables were expressed as mean (or median) ± standard deviation (or interquartile range) and categorical variables as number and percentage of patients. The χThe group’s proportional lethality and mortality indicators were calculated. To assess specific survival, the date of the first record at the Specialty Service was considered as the start of the survival period, and the deaths identified until the end of follow-up were treated as failures . Cases in which patients remained alive until the end of follow-up and those lost to follow-up  were censored. The method proposed by Kaplan-Meier was used to assess the cohort’s survival probabilities.Universidade Federal de Juiz de Fora (UFJF), under CAAE: 11094919.3.0000.5147 and opinion # 3.379.925, and the need for an Informed Consent Form (ICF) was waived, according to resolution 466/2012 of the National Health Council, item IV.8.This study was submitted to and approved by the Research Ethics Committee of the Of the 241 patients eligible for this study, 92 were excluded, of which 21 were from private practices, 66 were erroneously enrolled, four from other organizations and one with duplicate enrollment, for a total of 149 patients effectively enrolled, corresponding to 9.6% of the total newly diagnosed patients admitted between 2014 and 2018. There was a predominance of males (62.4%), age range between 50 and 59 years (65.8%), self-referring as white (57.7%), with 53.7% of patients with incomplete primary education or illiterate. In respect to the marital status, 82.5% of patients were not married or cohabiting. As for the use of drugs, the most frequent was tobacco (37.0%), followed by alcohol (34.2%) and Cannabis (8.2%).3 were found in 46.3% of sample. This profile is described in The comorbidities reported in medical records of the study group included hypertension in 28.9% of patients, depression in 15.8% and diabetes in 10.3%. Variable grades of immunodeficiency were detected as early as on admission, with 29.7% of cases considered as severe immunodeficiency, and 23.6% as moderate immunodeficiency. CD4+ T cell counts inferior or equal to 200cells/mmIn respect to antiretroviral therapy and association of drugs, between 2014 and 2016, the tenofovir + lamivudine + efavirenz combination was the preferred regimen. After 2017, the combination of tenofovir + lamivudine and the new integrase inhibitor, dolutegravir, became the predominant regimen for patients initiating treatment; other alternative regimens are still used in cases of contraindication, adverse events or virologic failure.As for monthly dispensation of antiretrovirals by the drug dispensing unit (UDM), 80 patients (56.7%) had six or more drug pickups in the first 6 months of treatment. At month 12, 81 (60%) users had more than 11 pickups and were considered adherent according to the adherence indicator defined for this study.3 after 6 months of treatment in only 9.1% of patients aged 60 years and over.Immune recovery, shown by an increment in the CD4+ T cell count over time resulted in an average gain of 139.63 at month 6, and 50.51 between month 6 and month 12, with an average increase of 157.63 cells at month 12.A total of 19 patients in the study group died between 2014 and 2018, with a mean age of 58 years, and with most of the deaths occurring in 2017. AIDS was confirmed as the primary cause of death in 13 cases. Therefore, AIDS lethality in the group was 8%, proportional mortality (considering confirmed causes) was 68%, and 24-month specific survival was 84.1%, as shown in  A paradigm shift has changed the idea of the disease being fatal, and the results of antiretroviral therapy have led to the disease being treated as a chronic condition, with infected patients living longer and aging with a life expectancy similar tho that of the general population.HIV infection is characterized by continuous loss of CD4+ T cells leading to immunodeficiency, opportunistic infections and death. Sexuality must be considered an integrating element of life for individuals at different life stages. However, a low education level affects the understanding of information relative to infection and prevention, contributing to increased vulnerability of this population.,9There was a predominance of male patients aged between 50 and 59 years in this sample, mostly single or separated and with lower education levels, as well as with sexual transmission as the most common transmission route. The data point to a change in the age pyramid in recent decades, with an increasing number of older patients infected. Although the epidemic affects more young adults, older patients account for significant percentages of new cases. An inflamed basal state, due to increased intestinal permeability and bacterial translocation caused by the virus, contributes to the prevalence of degenerative diseases typically related with aging and not related to AIDS in younger ages. In this study, 29.5% of patients had hypertension, and tobacco and alcohol use were the habits most often reported by the subjects in this sample, which are risk factors for atherosclerosis in HIV, in addition to the fact that older patients have an increased cardiovascular risk irrespective of antiretroviral therapy.People living with HIV can undergo accelerated aging, and those aged 50 years and over are considered elderly.Protocolos Clínicos e Diretrizes Terapêuticas) of the Ministry of Health. However, is worth highlighting that, in older patients, quality of life is more important than exposure to new regimens with potential side effects.The association of lower-toxicity antiretroviral drugs and drug-drug interactions can help in managing chronic conditions and geriatric syndromes and, in this regard, starting in 2017, an increase was seen in the use of the dolutegravir-containing regimen , according to the Clinical Protocols and Therapeutic Guidelines  and its surroundings, studies like this should further enhance the importance of team work and quality of care delivered.In the cohort of patients aged 50 years and over seen at the HIV/AIDS Specialty Care Service of a health care hub city in the Southeast of Brazil, higher adherence and viral load suppression were found in patients aged 61 years and over. After initiation of antiretroviral therapy, the sample showed an average gain of 157,63 CD4+ T cells in the first 12 months of treatment. The proportional mortality of the group was significant during the study period.Identifying HIV/AIDS in the elderly is important. Diagnostic delay leads to patients with advanced disease and negative prognostic impact. Health care professionals must be attentive to prevention measures for sexually transmitted infections, and the dialogue about sexual activity in later life must be encouraged. Likewise, checking for potential risk factors of non-adherence to the therapy is vital for effective disease management in this population.


There is increasing evidence that integrase strand transfer inhibitors (INSTIs) are associated with more weight gain when compared to other antiretroviral (ART) classes. Thus, the primary objective of the study was to evaluate the difference in weight gain at 6 and 18 months among treatment-naïve patients started on an INSTI-based versus a non-INSTI-based ART regimen. This was a retrospective cohort study of ART-naive adults who were initiated and maintained on INSTI and non-INSTI based regimens for at least 18 months at an HIV clinic in an inner-city hospital from January 2013 to June 2019. The non-INSTI-based regimens were darunavir (DRV) or rilpivirine (RPV)-based. Data collected included patient demographics, ART regimen, pre- and post-ART initiation weight in kilograms (kg), body mass index (BMI), CD4 count, and viral load. A two-tailed t-test was used to compare change in weight in INSTI-based versus non-INSTI-based regimens. Sub-group analyses were conducted using the ANOVA test.Out of 170 patients, 60% were initiated on an INSTI-based regimen, 7.1% on a DRV-based regimen, and 32.9% on a RPV-based regimen. Of the patients initiated on INSTI-based regimens, 73.5% were on elvitegravir (EVG),16.7% on dolutegravir, 8.8% on bictegravir, and 0.98% on raltegravir. The mean age at ART initiation was 38 years with majority of the patients described as Black. More male patients received an INSTI-based regimen compared to females (77.5% vs. 32%). The average change in weight at 6 and 18 months in the INSTI-based group vs non-INSTI-based group was +3.6 kg vs. +2.9 kg  and +5.7 kg vs.+4.8 kg  respectively. There was no significant average change in weight among the INSTI-based regimens (+3.6 kg), vs DRV (+5.3 kg), or RPV (+2.4 kg) based regimens at 6 months (p=0.108) and 18 months . Among the INSTIs, EVG was associated with the highest increase in weight at both 6 and 18 months (+3.9 kg and +5.8 kg). Forty-six percent of patients in the INSTI group were on tenofovir alafenamide (TAF) while no patients received TAF in the non-INSTI groups. When comparing INSTI-based to DRV or RPV-based regimens, there was no significant increase in average weight at 6 and 18 months.All Authors: No reported disclosures


Gender differences among patients with drug resistant tuberculosis (DRTB) and HIV co-infection could affect treatment outcomes. We compared characteristics and treatment outcomes of DRTB/HIV co-infected men and women in Uganda.We conducted a retrospective chart review of patients with DRTB from 16 treatment sites in Uganda. Eligible patients were aged ≥ 18 years, had confirmed DRTB, HIV co-infection and a treatment outcome registered between 2013 and 2019. We compared socio-demographic and clinical characteristics and tuberculosis treatment outcomes between men and women. Potential predictors of mortality were determined by cox proportional hazard regression analysis that controlled for gender. Statistical significance was set at p < 0.05.3 increment).Of 666 DRTB/HIV co-infected patients, 401 (60.2%) were men. The median (IQR) age of men and women was 37.0 (13.0) and 34.0 (13.0) years respectively (p < 0.001). Men were significantly more likely to be on tenofovir-based antiretroviral therapy (ART), high-dose isoniazid-containing DRTB regimen and to have history of cigarette or alcohol use. They were also more likely to have multi-drug resistant TB, isoniazid and streptomycin resistance and had higher creatinine, aspartate and gamma-glutamyl aminotransferase and total bilirubin levels. Conversely, women were more likely to be unemployed, unmarried, receive treatment from the national referral hospital and to have anemia, a capreomycin-containing DRTB regimen and zidovudine-based ART. Treatment success was observed among 437 (65.6%) and did not differ between the genders. However, mortality was higher among men than women  and men had a shorter mean (standard error) survival time (16.8 (0.42) vs. 19.0 (0.46) months), Log Rank test (p = 0.046). Predictors of mortality, after adjusting for gender, were cigarette smoking , an increase in alanine aminotransferase levels , and history of ART default  while a higher baseline CD4 count was associated with lower mortality (aHR = 0.94, 95% CI 0.89–0.99, p = 0.013 for every 10 cells/mmMortality was higher among men than women with DRTB/HIV co-infection which could be explained by several sociodemographic and clinical differences. The incidence of TB among PLHIV has steadily declined both globally and in sub-Saharan Africa (SSA) due to an increase in antiretroviral therapy (ART) coverage [Mycobacterium tuberculosis (Mtb) to rifampicin and isoniazid—among adult PLHIV to be only 50% [Tuberculosis (TB) is the leading cause of death among people living with HIV (PLHIV) accounting for 208,000 HIV-related deaths globally in 2019 [coverage . Howeveronly 50% . In SSA,only 50% . This isonly 50% .Gender differences in TB socio-demographic and biological risk factors, case notification rates and treatment outcomes are well recognised in literature , 8. In 2Characterising gender differences in DRTB/HIV co-infection is important in SSA where women have a disproportionally higher prevalence of HIV and a higher risk of TB/HIV-related mortality than men –17. IdenAll methods used in the study were carried out in accordance with relevant guidelines and regulations.high dose + Eto and 5 months of Mfx + Cfz + Z + E [This was a countrywide retrospective cohort of patients with DRTB/HIV co-infection in Uganda. We reviewed patients’ charts and treatment registers from 16 DRTB treatment sites in Uganda. Eligible patients had laboratory confirmed DRTB and HIV co-infection and a documented treatment outcome between 2013 and 2019. We excluded all DRTB patients with missing treatment charts, those who were not initiated on DRTB therapy, patients with DRTB whose therapy was later changed to first line agents and those for whom a treatment outcome was reported as “not evaluated”. There are 17 DRTB treatment sites in Uganda, comprising of 1 urban national referral hospital in the capital city , 13 rural regional referral hospitals and 3 rural district hospitals. We were unable to collect data from one regional referral hospital  due to COVID-19 travel restrictions at the time of data accrual. A full description of DRTB management in Uganda are described elsewhere . Briefly + Z + E . Bedaqui + Z + E .Socio-demographic characteristics were extracted from the patients’ charts using a data abstraction form. Specifically, age, gender, residence , employment and marital status, any history of cigarette or alcohol use, level of DRTB treatment initiation health facility , year of DRTB treatment initiation and history of TB treatment were extracted.HIV-related clinical variables extracted were the baseline CD4 T-cell count at the time of HIV diagnosis, status of HIV viral load suppression (suppression defined as < 1000 copies/ml) at the time of DRTB treatment initiation, ART status at DRTB treatment initiation, duration of ART use prior to DRTB therapy, drugs in the ART regimen, documented history of ART-default and use of cotrimoxazole prophylaxis. ART default was defined as a patient who had not visited the health facility HIV clinic in 3 or more consecutive months at any point in their care since they initiated ART . Other cData were analysed using SAS version 9.4 . Categorical socio-demographic and clinical variables were summarised as proportions and compared between men and women using Pearson’s Chi-square test and Fisher’s exact test. Continuous variables were summarised as medians with the corresponding interquartile range, and were compared between men and women using the Two Sample Kolmogorov–Smirnov Test. We used Kaplan Meier curves to assess the survival differences between men and women. Further, we used Cox proportional-hazard regression models to assess predictors of mortality. We tested the assumptions underlying Cox proportional hazards model and assessed the functional form of covariates. To develop a parsimonious model, we used hierarchical cluster analysis and assessed estimated coefficients for predictors in the univariate analysis to select representative predictors for each cluster of correlated variables. The predictors were retained in the model if they were significant at α = 0.1 using a backward selection procedure. While gender predicted mortality at bivariable analysis, it was eliminated during backward selection of variables for the multivariable model. We, therefore, intentionally kept in the model to control for its possible influence despite having α > 0.1. For all analyses we performed complete case analysis and statistical significance was set at p < 0.05.Participants’ charts were reviewed between January and March 2020. A total of 1427 charts were reviewed and 666 patients were eligible for the study. The study flow diagram is shown in Fig. 3. Viral load suppression (n = 68) was reported among 47 (69.1%). Eight (3.0%) women were pregnant at the start or during DRTB treatment. Other characteristics of patients with DRTB/HIV co-infection are shown in Tables Of 666 patients, 401 60.2%) were men. The median (IQR) age of the entire population was 36.0 (13) years. Among the patients, 622 (95.0%) were on ART, 587 (97.4%) were on cotrimoxazole prophylaxis and the baseline median (IQR) CD4 count (n = 190) was 179.5 (311.0) cells per mm% were meThe median (IQR) age of men and women was 37.0 13) and 34.0 (13) years respectively (p < 0.001). Men were more likely to have history of cigarette (p < 0.001) and alcohol use (p < 0.001) than women. Women were more likely to be unemployed (p < 0.001), unmarried (p < 0.001), and to receive DRTB treatment from the national referral hospital (p = 0.006). Other socio-demographic differences are shown in Table 3 and 34., p < 0.001), serum aspartate aminotransferase (41.3 (29.0) vs. 36.3 (26.4) U/l, p = 0.046), gamma-glutamyl aminotransferase (81.5 (89.0) vs. 55.5 (66.6) U/l, p = 0.016) and total bilirubin levels (0.35 (0.37) vs. 0.28 (0.31) mg/dl p = 0.004) than women. Additionally, men were more likely to be on Tenofovir-based ART (p = 0.019) and high-dose Isoniazid-containing DRTB regimen (p = 0.021). Women had a lower median (IQR) haemoglobin level (11.7 (3.5) vs. 12.6 (3.2) mg/dl, p < 0.001) and were more likely to have anaemia (p < 0.001), Zidovudine-based ART (p = 0.010) and Capreomycin-containing DRTB regimen (p = 0.022) than men. Other clinical differences are shown in Table Men were more likely to have MDRTB (p < 0.001), Isoniazid p = 0.021) and Streptomycin resistance (p = 0.045) and had higher median (IQR) creatinine (75.9 (31.9) vs. 64.3 (25.7) μmol/l1 and StrMen had a higher mortality than women  and shorter mean (standard error) survival time (16.8 (0.42) vs. 19.0 (0.46) months), Log Rank test (p = 0.046) . Compared to the year 2012, participants enrolled in 2018 had a higher risk for mortality , adjusted for age and gender. Enrolment in any other year did not predict mortality.As shown in Table In this study we compared the socio-demographic and clinical characteristics and treatment outcomes among men and women with DRTB/HIV co-infection in Uganda. We found that men were significantly more likely to be on Tenofovir-based ART and to have history of cigarette or alcohol use. They were also more likely to have MDRTB, Isoniazid and Streptomycin resistance, and had higher creatinine, ALT, GGT and total bilirubin levels. Conversely, women were more likely to be unemployed, unmarried, receive treatment from the national referral hospital and to have anemia, capreomycin-containing DRTB regimen and zidovudine-based ART. Mortality was higher among men, although gender did not predict mortality at multivariable analysis. Overall, cigarette smoking, history of ART default and higher ALT levels predicted a higher risk of mortality while higher baseline CD4 counts were associated with lower risk, independent of the gender.The ratio of women to men with DRTB/HIV co-infection was 1:1.5. This is consistent with the burden of TB by gender (women to men ratio of 1.1.5) in low and middle income countries . To explSimilar to our findings, men with TB were more likely to be older than women in a study from Portugal . It is lOur findings show a disproportionately high frequency of risk factors for poor DRTB outcomes among men with HIV/DRTB. Studies have reported cigarette smoking , alcoholConsidering the high frequency of risk factors for poor DRTB treatment outcomes among men, it is clear why men had higher mortality in our study. Men with HIV and DRTB co-infection have been reported to have higher mortality than women in South Africa as well . The ARTOur study has some limitations. Firstly, the retrospective nature of the study did not allow a detailed collection of the required data to achieve a complete characterisation of the patients. Specifically, the counts for viral load and CD4 were too few and this may have affected our ability to detect differences in these variables. During the period under study, HIV and DRTB care was not integrated, and participants received care for either disease at separate health facilities. It is therefore not surprising that these data were not consistently documented at the DRTB treatment site. Secondly, HIV treatment has significantly improved over the study period from the period when the CD4 count was used to determine eligibility for ART initiation to the “test and treat” era. Additionally, there have been several changes in DRTB treatment recommendations in the last 7 years. However, the year of enrolment into care was not associated with higher risk of mortality when adjusted for gender. While patients enrolled in 2018 had higher risk of mortality, this is likely due to documentation bias of deaths since majority of patients would not be expected to have completed treatment by 2019. However, the strength of our study is in its inclusiveness of patients from multiple sites across the country and thus reflective of treatment outcomes in the study population nationwide. Our study provides baseline data to inform policy and prospective studies exploring gender-targeted therapies in this population.Men had more risk factors of mortality than women. Cigarette smoking cessation and improving ART adherence could potentially reduce the risk of mortality among DRTB/HIV co-infected individuals. ART and DRTB regimens need to be adapted to patients’ risk for adverse drug events for which monitoring should be performed with fidelity.


Among the overall population, we observed an increase in CD4+ T cells count by 30.1% , in CD8+ T cells count by 7.1%  and in CD4+/CD8+ ratio by 21.5% . Lipidic profile was characterized by decreasing total cholesterol/HDL ratio by 8%  and LDL by 6.8% . Total body weight increased by 1.8%  and BMI by 4.2% , even remaining within the healthy range. Hepatic and renal profile were not altered by the switch, nor were adverse events and/or discontinuations events detected. In conclusion, BIC/FTC/TAF is effective, safe and well tolerated in real life and among PLWH older than 55.Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF) is a recommended once-daily single tablet regimen for the treatment of people living with HIV-1 (PLWH). We aimed to assess efficacy, safety and tolerability of BIC/FTC/TAF among PLWH, with a specific focus on people older than 55 years. Thus, we recruited an observational retrospective real-life cohort including all PLWH who underwent a therapeutic switch to BIC/FTC/TAF, independently from the provenience treatment regimen. After 48 weeks of follow-up, 147 PLWH were included and 93 were older than 55 years. PLWH with HIV-RNA < 37 copies/mL increased from 140 to 146 ( The last few decades saw dramatic changes in the natural history of HIV-1 infection, which has been transformed by the advent of antiretroviral therapy (ART): nowadays, life expectancy of people living with HIV-1 (PLWH) has a quite similar length of general population, and an increasingly large share of HIV-1 population is aging ,3. Moreo®, is a relatively new antiretroviral STR for the treatment of HIV-1 infection, based on the second-generation integrase strand transfer inhibitor (INSTI) bictegravir [Bictegravir/emtricitabine/tenofovir alafenamide fumarate (BIC/FTC/TAF), commercialized as Biktarvytegravir ,7,8. Sevtegravir ,10,11, btegravir , especiategravir . Thus, wThis is an observational retrospective real life cohort describing data from PLWH who switched their current ART to a single tablet regimen based on BIC/FTC/TAF.+, CD8+ and CD4+/CD8+ ratio changes from baseline to week 48; (c) Metabolic profile  changes from baseline to week 48; (d) Detection of neurological symptoms or clinical signs objectivable with the neurological examination referable to potential side effects of the drug; (e) Reasons to switch to BIC/FTC/TAF; (f) Adverse events related to BIC/FTC/TAF; (g) Risk factors related to interruption of treatment with BIC/FTC/TAF; (h) Adherence to BIC/FTC/TAF; (i) To evaluate the same primary and secondary objectives in the group of PLWH older than 55 years. The primary objective was to compare changes in HIV-RNA from baseline to week 48 after switching to BIC/FTC/TAF evaluating the percentage of PLWH with HIV-RNA < 37 copies/mL. Secondary objectives were: (a) Percentage of PLWH presenting virologic failure (HIV-RNA ≥ 37 copies/mL); (b) CD4The BICTEL cohort is an observational cohort including all PLWH who underwent a therapeutic switch to BIC/FTC/TAF, independently from the provenience ART regimen. Thus, PLWH who were receiving a protease inhibitor (PI), boosted or not, based regimen, or a non nucleosidic retrotranscriptase inhibitor (NNRTI) based regimen, as well as an INSTI, boosted or not, based regimen are enrolled. Data are retrospectively collected from patient’s medical records.+ T cells count, CD8+ T cells count, CD4+/CD8+ ratio, clinical assessment of eventually neurological side effect of the drug. A self-reported questionnaire regarding adherence to BIC/FTC/TAF was also administered at baseline and after 48 weeks. Adverse events (AEs) were classified as mild/moderate, severe or life threatening, according to the Division of AIDS (DAIDS) Classification. AEs were considered unrelated to BIC/FTC/TAF, possibly related or related, according to the physician’s evaluation.This study enrolled only PLWH included in the BICTEL cohort and with a follow-up of at least 48 weeks. The following information were extracted from the cohort database: demographics , smoking, time from HIV-1 diagnosis (years), history of AIDS diagnosis, current hepatitis B virus (HBV) co-infection, former hepatitis C virus (HCV) infection, presence of co-morbidities , chronic kidney disease (CKD), osteopenia and osteoporosis), 10 years atherosclerotic cardiovascular disease (ASCVD) risk score assessed by the ASCVD Risk Estimator Plus of the American College of Cardiology , number p-value of less than 0.05 was considered as statistically significant. All data were analyzed using RStudio  and Microsoft Excel for Mac (Version 16.48).Baseline characteristics of enrolled patients were considered as median values and interquartile range (IQR), simple frequencies (#) and proportions , according to the variable type, continuous or categorical, respectively. Normality of variables distribution was assessed by the Shapiro–Wilk statistics. The change from baseline was assessed by row difference  or mean relative difference . Longitudinal analysis was assessed by the paired Wilcoxon test for continuous variables and by the Fisher test for categorical variables. All tests were two-sided and a The study was independently approved by the Committee of the Public Health and Infectious Diseases Department of “Sapienza” University of Rome and by the local Ethics Committee . Written informed consent was obtained from each participant prior to the enrollment in the trial. At the end of the enrollment of the current study, a total of 147 PLWH were included in this 48-week follow-up; among them, 93 were over 55 years old. Details are summarized in + count of 584 (454–764) cells/μL, a median CD8+ count of 750 (580–1002) cells/μL and a mean CD4+/CD8+ ratio of 0.7 (0.6–0.83). Overall, 46 (31.3%) of all patients had a previous AIDS history according to CDC classification, while HBV and HCV co-infections were present in 12 (8.2%) and 16 (10.9%) participants, respectively. The 10 year cardiovascular risk assessed by the ASCVD score was detected with a median of 39% (20–50). Smokers were 98 (66.7%). At least one non-communicable clinical disease or co-morbidity was presented by 87 (59.2%) PLWH: the most prevalent was osteopenia in 35 (23.8%) participants, followed by hypertension in 31 (21.1%), osteoporosis in 25 (17%), type 2 diabetes and cardiovascular diseases in 12 (8.2%). Fifty-seven (38.8%) patients were receiving at least one non-ART co-medication, and 32 (21.8%) more than one. The median age was 57 years (49–61). In addition, 104 (70.7%) were males with a median of 16 years (10–22) from HIV-1 diagnosis. HIV-RNA at baseline was under the threshold of 37 copies/mL for more than 6 months in 140 (95.24%) of the patients, with an average time with HIV-RNA < 50 copies/mL before the switch of 37 months (37–48). The immunological profile was represented by a median CD4Overall, the vast majority of PLWH enrolled in the current study were receiving a prior PI-based ART , while 23 (15.6%) were receiving an INSTI-based regimen and 29 (13.6%) an NNRTI-based regimen. Seven (4.8%) patients were receiving a combination of PI and INSTI. Out of 147 enrolled PLWH, only 5 (3.4%) were coming from an ABC-based regimen, with the majority of patients coming from a tenofovir-based regimen before the switch: 94 (63.9%) of them were receiving a TDF-based ART, while 33 (22.4%) were receiving a TAF-based regimen. Eleven (7.5%) patients were switched from a dual ART to BIC/FTC/TAF: 7 (4.8%) were receiving a dual therapy based on association of PI and INSTI, 3 (2%) was receiving dolutegravir + lamivudine and 1 (0.7%) was receiving lopinavir/ritonavir + lamivudine. Three (2%) patients were taking a monotherapy with darunavir/cobicistat. One (0.7%) patient was receiving atazanavir + ritonavir + zidovudine/lamivudine. The most frequent reason for switching to BIC/FTC/TAF recorded was to simplify a more-pills regimen to a single tablet regimen, 95 PLWH (64.6%). Toxicity accounted for 34 (23.1%) of the total switch. Minor causes recorded were: 14 pro-active switch (9.5%), 3 adherence improvement (2%), and 1 adverse event (0.7%).+ count of 585 (462–728) cells/μL, a median CD8+ count of 750 (595–1000) cells/μL and a mean CD4+/CD8+ ratio of 0.7 (0.6–0.82). 34 (36.6%) of all elderly PLWH had a previous AIDS history according to CDC classification, while HBV and HCV co-infections were presented in 8 (8.6%) and 13 (14%) participants, respectively. The median 10 years cardiovascular risk, assessed by the ASCVD score, was 39% (19–50), and smokers were 59 (63.4%). Non-communicable clinical diseases were over-represented in this sub-sample, with 64 (68.8%) PLWH presenting at least one comorbidity: the most prevalent was osteopenia in 24 (25.8%) participants, followed by hypertension in 23 (24.7%), osteoporosis in 22 (23.7%), cardiovascular diseases in 11 (11.8%) and type 2 diabetes in 10 (10.8%). Higher polypharmacy was detected among PLWH > 55 years, with 43 (46.2%) of patients receiving at least one non-ART co-medication, and 28 (30.1%) more than one. Overall, the vast majority of elderly PLWH enrolled in the current study were receiving a PI-based ART , while 16 (17.2%) were receiving an INSTI-based regimen and only 10 (10.8%) an NNRTI-based regimen. Two patients (2.7%) received an ABC-based regimen, while 62 (66.7%) of them a TDF-based and 19 (20.4%) a TAF-based regimen. Eight (8.6%) patients were switched from a dual ART to BIC/FTC/TAF: 4 (4.3%) participants were receiving a combination of PI and INSTI, 3 (3.2%) were receiving dolutegravir + lamivudine and 1 (1.1%) was receiving lopinavir/ritonavir + lamivudine. Two (2.1%) patients were taking monotherapy with darunavir/cobicistat. The most frequent reason reported for the switch to BIC/FTC/TAF was simplification to a single tablet regimen , followed by toxicity in 21 (22.6%), pro-active switch in 6 (6.5%), adherence improvement in 3 (3.2%) and an adverse event in 1 (1.1%).Among the 147 PLWH recruited into the study, 93 were older than 55. In addition, 69 (74.2%) were males with a median age of 60 years (57–64) and a median time from HIV-1 diagnosis of 19 years (13–25). HIV-RNA at baseline was <37 copies/mL for more than 6 months in 90 (96.8%) of the patients, with an average time with HIV-RNA < 50 copies/mL before the switch of 37 months (37–48). The immunological profile was represented by a median CD4No AEs attributed to the use of BIC/FTC/TAF were reported in the medical records during the follow up.p-value = 0.033). All 3 PLWH older than 55 with HIV-RNA ≥ 37 copies/mL at baseline showed with HIV-RNA < 37 copies/mL at week 48 . A comparable improvement was detected in the immune profile. The median CD4+ T cells count increased from 584 (454–746) cells/μL at baseline to 767 (590–1033) cells/μL after 48 months, and CD8+ T cells count increased from 750 (580–1002) cells/μL to 850 (651–1032) cells/μL. Such improvements were statistically significant, with an increase in CD4+ T cells count by 30.1% , and an increase in CD8+ T cells count by 7.1% . A statistically significant increase (21.5%) in CD4+/CD8+ ratio was also detected, from 0.7 (0.6–0.83) to 0.9 (0.8–1) . Similar results were observed among PLWH older than 55 years. Among them, CD4+ T cells count increased from 585 (462–728) cells/μL to 762 (589–956) cells/μL, and CD8+ T cells count increased from 750 (595–1000) cells/μL to 850 (677–1000) cells/μL. The improvement in CD4+ T cells count (increase by 28.3%) was statistically significant , as well as the CD8+ T cells count change (increase by 3.4%) . CD4+/CD8+ ratio improved significantly by 22.2% from 0.7 (0.6–0.82) to 0.9 (0.8–1) at week 48 —After 48 weeks of follow-up, the number of participants with HIV-RNA < 37 copies/mL increased from 140 (95.3%) to 146 (99.3%), with a consequent reduction of those with HIV-RNA ≥ 37 copies/mL from 7 (4.7%) to 1 (0.7%) , with a significant LDL component decrease of 6.8% from 108 (88–133) mg/dL to 100 (84–131) mg/dL . HDL cholesterol significantly increased by 4.4% from 49 (41–60) mg/dL to 50 (44–62) mg/dL . Such changes were reflected into the total cholesterol/HDL ratio, which decreased by 8% from 3.77 (3.12–4.71) to 3.40 (2.91–4.19) . Changes in total body weight were represented by a significant increase of 1.8%, rising from 77 (69–83) kg to 79 (71–85) kg , with a parallel increase of 4.2% in BMI from 22 (20–24) to 22 (21–25) .A significant change in the lipidic profile was detected at the end of the 48 weeks observation. In the overall population, among the fasting lipid parameters evaluated, total cholesterol levels significantly decreased by 6.9% from the median value of 190 (168–212) mg/dL to 178 (155–202) mg/dL , with a parallel significant LDL component decrease of 6.7% . HDL cholesterol significantly increased by 6.8% from 46 (40–57) mg/dL to 50 (43–61) mg/dL , and the total cholesterol/HDL ratio decreased by 8.6% from 3.85 (3.37–4.74) to 3.48 (2.93–4.24) . Again, an increase in total body weight by 1.9% from 77 (69–86) kg to 78 (71–88) was observed, even if not statistically significant (p = 0.062), while BMI increased significantly by 0% (0%–5.6%) from 22 (21–24) to 22 (21–23.25) —Similar results were detectable among over 55 PLWH. Total cholesterol levels significantly decreased by 6.9% from 191 (169–214) mg/dL to 180 (156–203) mg/dL , no change (0%) was detected in eGFR estimated by CKD-EPI score, which showed levels of 86 mL/min/1.73 m2 both at baseline (76–96) and at week 48 (72–95) . Interestingly, despite a significant augment of 0.8% observed in serum creatinine levels, which increased from 0.93 (0.84–1.04) mg/dL to 1.00 (0.84–1.12) mg/dL ; eGFR estimated by CKD-EPI score decreased from 83 (74–91) to 82 (72–91) ml/min/1.73 m2 —Such trends were not detectable among over 55 PLWH, where nor serum creatinine nor eGFR showed significant changes along time (change from baseline: 0%): serum creatinine level increased from 0.9 (0.81–1.01) mg/dL to 0.99 (0.82–1.11) mg/dL . Similarly, among over 55 PLWH, AST and ALT non-significantly decreased from 21 mg/dL to 20 mg/dL  from baseline  to week 48  —Hepatic profile was safe, and no significant differences were detected in AST and ALT levels from baseline to week 48 among both overall and over 55 PLWH. Among the overall population, AST and ALT non-significantly decreased from 21 mg/dL to 20 mg/dL  from baseline  to week 48  . Similar results were observed among over 55 PLWH , and a significant increase by 4.2% to 99% (95–99) was detected .BIC/FTC/TAF is a recommended once-daily STR antiretroviral regimen for the treatment of both naïve and experienced PLWH. Results deriving from our real-life switching experience confirmed the efficacy and tolerability of BIC/FTC/TAF over 48 weeks. Of note, no discontinuation occurred along the entire study period and adherence level to therapy significantly increased, as assessed by patients’ self-reported questionnaire. This remarkable result is firstly related to the virological efficacy of BIC/FTC/TAF. In line with switching studies which documented non-inferiority of BIC/FTC/TAF to its comparators ,10, perc+ T cells count, CD8+ T cells count and CD4+/CD8+ ratio among both the overall population and over 55 PLWH. Our observations that confirm a positive effect of BIC/FTC/TAF among elderly PLWH is reassuring, considering that aging is known to be accompanied by immune senescence, with the CD4+/CD8+ ratio being a strong indicator of frailty and multi-morbidity [Significant changes in the immune profile were detected, with a remarkable improvement of CD4orbidity ,17.The absence of discontinuation events recorded in our real-life experience is probably also due to the absence of AEs, not reported by receivers during the 48 weeks of observation. The study design focused on Central Nervous System (CNS)-related AEs, with a headache being the most frequent AE reported by pivotal studies and the entire INSTI class being under observation for side effects of neuro-psychiatric interest . NonetheThe renal tolerability and safety of BIC/FTC/TAF documented by our longitudinal analysis is in line with data available from literature. We detected a significant increase in creatinine among the overall population, not accompanied by a parallel decrease of eGFR. Bictegravir inhibits creatinine OCT2- and MATE1-mediated tubular secretion ,6, thus Among fasting lipid parameters evaluated, we documented a global improvement of the lipid profile, characterized by a significant reduction of total cholesterol, LDL cholesterol and total cholesterol/HDL ratio, with a parallel increase in HDL cholesterol. Specifically, the reduction of total cholesterol as well as of total cholesterol/HDL ratio are consistent with findings at week 48 from pivotal studies comparing ART-experienced PLWH switching to BIC/FTC/TAF from boosted PI-based regimen ,10. RemaIndeed, despite the improvement in the lipid profile, after 48 weeks, our study participants experienced a significant increase in median body weight and a slight BMI increase, except among over 55 PLWH whose body weight increase did not reach statistical significance, probably due to a lack of statistical power. Several real-life experience clinical studies are also reporting warning effects of new ARV regimens on body weight and BMI and INSTIs are associated with more weight gain than PIs and NNRTIs, and dolutegravir and bictegravir more than elvitegravir/cobicistat . However+/CD8+ ratio. Renal, hepatic and fasting lipid profile did not show any clinically significant changes during the follow up. A slight increase in body weight and BMI was detected, even if BMI remained within the healthy range. Finally, this STR helps the patients to maintain a high adherence profile as depicted by the results of the patients’ self-reported questionnaires, showing higher adherence compared to baseline.Although further studies with larger sample size and an adequate follow-up time are needed, our 48 weeks real-life results show that the BIC/FTC/TAF regimen is an effective and tolerable choice for the treatment of virologically suppressed PLWH, regardless of age. All PLWH maintained the virological suppression with a significant improvement of the immune profile. Moreover, we detected an improvement in immune activation profile, reflected by the increase in CD4


Viral suppression prevents HIV transmission and disease progression, but socio-economic and clinical factors can hinder the goal of suppression. We evaluated factors associated with viral non suppression (VNS) and persistent viremia (PV) in people living with HIV (PLHIV) receiving antiretroviral therapy (ART) in Guatemala.We conducted a cross sectional analysis using data from an ongoing cohort of PLHIV attending the largest HIV clinic in Guatemala. Univariable and multivariable analyses were conducted between PLHIV with viral suppression and detectable viremia. VNS was defined as most recent HIV RNA ≥ 200 copies/ml and PV as two consecutive HIV RNA ≥ 200 copies/ml.p < 0.01), treatment interruptions , excessive alcohol consumption  perceived difficulty attending healthcare  and low CD4 at diagnosis  were independently associated with VNS on multivariable regression.Of 664 participants, 13.3% had VNS and 7.1% had PV. In univariable analysis disaggregated by gender, low income, poor education, perceived difficulty attending healthcare, and alcohol use were associated with VNS in men while low CD4 at diagnosis, multiple prior ART regimens and treatment interruptions were significant in both genders. Multiple prior ART regimens (adjusted Odds Ratio (aOR) 2.82, , We conclude that socio-economic and clinical factors influence viral suppression in our cohort and vary between men and women. Gender specific approaches are necessary to achieve the 90% suppression goal.The online version contains supplementary material available at 10.1186/s12981-021-00400-9. Over the last two decades, huge strides have been made in the control of the HIV epidemic. This is widely attributed to the global scale-up in access to antiretroviral therapy (ART). In 2013, the Joint United Nations Programme of HIV/AIDS (UNAIDS) proposed the 90–90–90 goal as a benchmark to contribute to the end of the HIV epidemic. The goal was to diagnose 90% of people living with HIV (PLHIV), provide ART for 90% of those diagnosed and achieve viral suppression in 90% of those receiving ART by 2020 .Viral suppression plays a crucial role in limiting onward transmission of HIV. As HIV prevalence increases, viral suppression must be achieved in order to prevent new infections . SeveralThe main concern in Latin America is that progress, while steady, is uneven between regions . In GuatSeveral barriers to viral suppression have been identified and include but are not limited to stigma, difficulty in accessing healthcare because of location or financial status , 13, alcWe used data from baseline interviews obtained as part of an ongoing prospective cohort study on comorbidities in PLHIV attending the Dr. Carlos Rodolfo Mejia Villatoro Infectious Diseases Clinic at Roosevelt Hospital in Guatemala City. The clinic is the largest HIV clinic in the country and provides free care for over 5000 PLHIV nationwide. PLHIV 18 years or older attending the HIV clinic are eligible for enrollment in the cohort. PLHIV were enrolled after providing verbal consent, and data was collected with in-depth interviews, clinical evaluation, and review of clinical files. The study was approved by the institutional review board of Roosevelt Hospital. The baseline interviews, containing questions on demographics, housing, medical conditions, and health risk factors, were conducted in Spanish and took place from July 2019 to February 2020. Study data were collected and managed using REDCap electronic data capture tools hosted at Washington University in Saint Louis .For the current analysis we included all PLHIV enrolled in the cohort that had been prescribed at least six consecutive months of ART since their initial diagnosis and had a recent viral load. Recent viral load was defined as a HIV viral load taken within three months prior or one month following the enrollment interview for participants with clinic visits every 3-months and viral load taken six months from enrollment at most for participants with 6-months clinic visits. Viral non-suppression (VNS) was defined as a viral load ≥ 200 copies/ml and persistent viremia (PV) was defined as two consecutive viral loads ≥ 200 copies/ml.The continuous variables age, travel time and travel cost to HIV care, individual monthly income, years of education, number of prior ART regimens, CD4 count at diagnosis and days of treatment interruptions were recategorized into binary variables for analysis. Age 50 and below or over 50 years was used to compare younger and older adults, respectively, as defined by the Center for Disease Control and Prevention (CDC) . Travel Categorical variables were defined as follows. Excessive alcohol consumption was defined as binge drinking (four or more drinks in one occasion for women and five or more drinks for men) and heavy drinking (eight or more drinks in a week for women and 15 or more drinks in a week for men) within the past month, in accordance with the CDC definitions . Access p ≤ 0.05 to evaluate independent factors associated with VNS and PV.Statistical analyses were performed using SPSS  software version 23. Baseline characteristics were analyzed with respect to frequency and percentage. Normality was evaluated for all numeric variables using Shapiro Wilk test with kurtosis and skewness. Baseline characteristics were compared with the nonparametric Pearson Of 929 participants enrolled in the cohort, 664 had a recent viral load and had completed at least six months of ART. The median age was 39 years [interquartile range (IQR) 32–48], 356 (53.6%) were male, 493 (74.2%) were heterosexual and 99 (14.9%) self-identified with indigenous ethnicity. Almost half of the participants (49.2%) had less than or equal to primary education and only 60 (9.0%) had a bachelor’s degree or higher. A total of 441 (66.4%) participants reported being employed. Out of these, 23.7% (158) were females and 42.6% (283) were males. Five hundred sixty had no income or earned less than the CBA with 211 (31.8%) having to borrow money to cover travel costs. The main transportation used was public buses . Travel time varied greatly, but 80 (12%) participants traveled four or more hours to reach healthcare.3 (IQR 57–341) and 77,000 copies/ml  respectively. Current median CD4 count was 473 cells/mm3 (IQR 283–689). A total of 262 (39.5%) of our participants were in their first ART regimen, 402 (60.5%) had at least one prior ART regimen and 105 (15.8%) had multiple prior ART regimens. Other characteristics arranged by virologic status are presented in Table Comorbidities were present in 408 61.4%) and only 21 (3.2%) participants were co-infected with hepatitis B. Median CD4 count and viral load at diagnosis were 178 cells/mm.4% and op ≤ 0.05) and were included in the multivariable analysis (Table p < 0.01), multiple prior ART regimens , excessive alcohol consumption , low CD4 count at diagnosis , bisexual orientation , and perceived difficulty attending healthcare , were all associated with increased risk of VNS. Among those with perceived difficulty, the most commonly reported reasons for such difficulty were difficulty getting time off from work  and price of transportation  , but the same association was not seen in women . Multiple-daily dosing , excessive alcohol consumption , income below or equal to the CBA , and primary education or less  were also significantly associated with VNS in men but not in women. Past AIDS defining illnesses, treatment interruptions, low CD4 count at diagnosis and having multiple prior ART regimens were still significantly associated with VNS in both genders in univariable analysis. In separate multivariable models however, only multiple prior ART regimens was significant in both men and women.Univariable analysis disaggregated by gender , treatment interruptions , and low CD4 count at diagnosis  were associated with higher odds of PV, as shown in Table In the univariable analysis for PV as the outcome of interest, past AIDS defining illness, low CD4 count at diagnosis, treatment interruptions, multiple prior ART regimens, multiple-daily dosing, bisexual orientation, perceived difficulty attending healthcare, and having no comorbidities were significantly associated with PV. In the multivariable analysis, participants with multiple prior ART regimens (aOR 4.63, , To our knowledge, a detailed analysis on factors that influence virologic outcomes in PLHIV has not been performed in Guatemala. Our study found factors associated with VNS and PV among PLHIV in Guatemala, complementing prior findings about the modifiable and unmodifiable factors associated with detectable viremia in PLHIV on ART –28. SevePerceived difficulty attending healthcare was one of the variables associated with VNS. Several socio-economic factors have been shown to have a negative impact on perception of HIV care such as quality of services, financial fairness, transportation convenience, perceived negative attitude, and stigma . HoweverWe found that paradoxically, having no comorbidities increases the risk of VNS and PV. Several studies have found no association or a similar association to our study –33. ThisIn this study, indigenous ethnicity and age did not have an impact on VNS or PV. This differs from other studies where ethnic minorities , 37 and Gender was also not associated with VNS in the overall population, in keeping with previous research on gender and detectable viremia , 40. HowUnlike VNS, we found no social or economic variables associated with PV. However, the same variables related to HIV background were significantly associated with both VNS and PV. Having multiple prior ART regimens was independently associated with both outcomes with the highest odds ratio of all relevant variables. Similar findings are reported in South Africa , Uganda Low CD4 count at diagnosis was another variable significantly associated with VNS and PV, similar to what was found in several cohort studies , 52–54. We also demonstrate that treatment interruptions are associated with VNS as well as PV. This result is similar to what is reported from multiple studies where missing any amount of days of ART is significantly associated with PV , 38, 47.Pandemic clade [There are important limitations in our study. Although all participants were selected randomly, a small number of people declined participation mainly due to insufficient time to conduct an interview. Those that were temporarily lost to follow up in HIV care, hospitalized in-patient, or attending prenatal care were not captured in this cohort. Adolescents were not considered due to health policies regarding age and sexual health consent. Transgender population and sex workers are underrepresented in our cohort due to the lack of public outreach and gender specific programs . We wereic clade . TreatmeThis is the first study, to our knowledge, demonstrating potential social and clinical influences on VNS and PV in PLHIV in Guatemala. In our analysis, we found that social factors such as excessive alcohol consumption, perceived difficulty attending healthcare, and bisexual orientation were significantly associated with VNS in PLHIV in Guatemala. In this cohort low CD4 count at diagnosis, treatment interruptions, multiple prior ART regimens, and multiple-daily dosing were significantly associated with both VNS and PV. This highlights potential areas of improvement to advance towards achieving the goal of 90% suppression. Simplifying regimens when possible, addressing personal barriers, improving access to ART outside of the clinic, and concentrating efforts on groups at greater risk are key interventions to continue improving viral suppression. The strong link between perceived difficulty attending healthcare and VNS warrants further exploration, as PLHIV often need to overcome barriers to optimal care.Additional file 1: Table S1. Univariable and multivariable logistic regression of viral non-suppression in 308 women† living with HIV on ART in Guatemala.Additional file 2: Table S2. Univariable and multivariable logistic regression of viral non-suppression in 356 men living with HIV on ART in Guatemala.Additional file 3: Table S3. Reasons for perceived difficulty attending HIV care in 258 PLHIV on ART in Guatemala.


Anti-retroviral therapy regimen discontinuations become a big challenge and cause diminishing the clinical and immunological benefit of treatment in Ethiopia. It reduces both the duration and the chance of viral control due to cross-resistance between different alternative drugs and overlapping toxicity between and within a class of antiretroviral drugs in Ethiopia. However, information’s on the time of initial regimen discontinuation and its predictors are not well studied.This study aimed to assess the time to initial highly active antiretroviral therapy discontinuation and its predictors among HIV patients in Felege Hiwot comprehensive specialized hospital, North West Ethiopia.Institution-based retrospective cohort study was conducted among 418 HIV patients who started HAART from January 1, 2014, to December 31, 2019. Data were collected from the patient chart using a data extraction tool. The Kaplan–Meier curve was employed to compare survival rates. Multivariable Cox proportional hazard regression was applied to identify independent predictors of time to initial regimen discontinuation.3 , 100–199 cells/mm3 , baseline WHO clinical stage IV  and stage III  and TB infection .A total of 418 patients on anti-retroviral therapy were followed. Incidence of initial HAART discontinuation was 16.7/100 person year. The median survival time was 3.5 years. Predictors showed association for time to initial HAART discontinuation were taking > 1 ART pills/day , baseline CD4 count < 100 cells/mmMost of the discontinuation occurred after 1 year of initiation of HAART. Baseline WHO clinical stage, TB infection, baseline CD4 count, and taking > 1 ART pill/day were found predictors of initial HAART regimen discontinuation. Work on early detection of HIV before the disease is advanced and initiation of one ART regimen daily is vital for survival on the initial regimen. Proper management of patients living with the human immune deficiency virus (HIV) is a comprehensive, lifelong process focused on the patient’s needs. The core component of treatment and care of people living with HIV is the provision of antiretroviral treatment. The optimal form, known as "highly active antiretroviral treatment" (HAART), increases the length and quality of life for infected individuals while reducing the onward transmission of the virus .HAART, or simply antiretroviral therapy (ART), is the use of a combination of three or more antiretrovirals to achieve durable suppression of viral replication. Since the evolution of the first agent, Zidovudine, in 1987, substantial advances have been made in ART. Only patients with advanced symptomatic disease were prescribed Zidovudine as a monotherapy in a five-times-daily dose. In mid-1996, it was discovered that these drugs are far more effective when three or more are taken at the same time. The advent of these highly active antiretroviral treatments has dramatically reduced the morbidity and mortality associated with HIV infection and has improved the prognosis for people living with HIV infection (PLHIV) or AIDS , 3.These optimum clinical and public health achievements of antiretroviral therapy require consistent long-term adherence. HIV/AIDS is a chronic, lifelong disease with no known cure, and therefore, people living with HIV have to be followed medically for the rest of their lives , 5. HoweAs long as there is virological success, the initial regimen continues unless there is a need for regimen discontinuation due to drug side effects, co-morbid illness, pregnancy, and other conditions , 10, 11.Different studies showed that baseline WHO clinical stage , treatmeIn resource-limited settings, including Ethiopia, where treatment options are limited, designing strategies to increase the durability of the original regimen is essential. To achieve this goal, it is important to determine the time when the initial HAART is discontinued and predictors for the time to initial HAART regimen discontinuation. However, information on the time to initial HAART regimen discontinuation and its predictors in Ethiopia is not well studied.Therefore, this study is aimed at determining the time of initial HAART regimen discontinuation and its predictors among HIV patients. Results from this study will help to design appropriate measures to increase the duration of the original regimen among patients on antiretroviral therapy that preserve future treatment options.An institution-based retrospective cohort study was conducted to assess the time of initial HAART regimen discontinuation and its predictors among HIV seropositive patients initiated on HAART at Felege Hiwot comprehensive specialized hospital, Bahir Dar, North West Ethiopia, from January 1, 2014, to December 31, 2019.Felege Hiwot comprehensive specialized hospital is one of the largest hospitals in Bahir Dar, which was established in 1960. The HIV care service of the hospital was initiated in 2003. Since 2003, when the hospital started ART, 13,042 patients have been enrolled in HIV care. Six thousand six hundred twenty patients were actively following their treatment, and 1538 patients started ART between January 1, 2014, and December 31, 2019. Standardized monitoring and evaluation tools and the data collection and management process were well organized and supported by the electronic database system of the hospital, which was suitable for accessing data.The source population was all HIV patients who had been on follow-up at the ART clinic of Felege Hiwot, a comprehensive specialized hospital. The study population was all HIV patients who initiated ART at Felege Hiwot comprehensive specialized hospital from January 1, 2014, to December 31, 2019, and following their chronic care and treatment at the hospital.Patients who were initiated on combined ART and had a follow-up in Felege Hiwot comprehensive specialized hospital and who began ART between January 1, 2014, and December 31, 2019, were included in the study, whereas patients who were initiated on antiretroviral treatment outside of Felege Hiwot comprehensive specialized hospital and transferred in, as well as charts with incomplete demographic and clinical information, were excluded.Using epi info version 7.2.2 and by considering the 95% confidence interval, 5% marginal error, 80% power, and 1:2 proportions, the maximum sample size was calculated by taking factors that gave the maximum sample size from the significant predictors in previous studies. The predictors which were significantly associated with the dependent variable were: co-medication with ART , and WHOUsing patient charts and the ART electronic database, data were collected from Felege Hiwot, a comprehensive specialized hospital HIV care clinic. Patient chart numbers were from the electronic database as a sampling frame. From 1538 patients who started HAART from January 1, 2014, to December 31, 2019, 418 charts were selected and reviewed by a simple random sampling technique through computer-generated random numbers.The dependent variable was survival time to initial HAART discontinuation (in a year).Independent variables were categorized in to five themes: sociodemographic factors: Age (in year), Sex, marital status, educational level and occupation; clinical factors: weight, WHO clinical stage, TB co-infection and pregnancy; Patient-related factor: Adherence status, substance use and disclosure status; drug-related factors: initial HAART regimen, ARV Drug toxicity, Pill burden, and Co-medication; and immunological and virological factors: Baseline CD4 count, latest CD4 count, initial viral load and latest viral load.The data abstraction tool was developed from the available information on the patient records, which had first been observed, and it had three parts: sociodemographic factors; baseline clinical, laboratory, and ART information; and patient follow-up information. Three trained nurses and a supervisor were recruited for data collection along with the principal investigator. One data clerk also supported them by identifying the charts that were retrieved using the patient registration number in the database system.The data extraction tool was pre-tested among 5% of the sample population, and one-day training was provided for data collectors and a supervisor on the objectives and relevance of the study. The supervisor managed the data collection process every day, and the principal investigator also checked completed questionnaires for completeness of information every other day. Gaps identified were immediately communicated to the supervisor and data collectors.The collected data had been coded, cleaned, and entered by EpiData version 3.1 and was exported to the statistical package for social science (SPSS) version 23 for analysis. Descriptive statistics were used to describe the demographics, baseline, and follow-up data. The incidence density rate was calculated for the entire study period. To calculate the rate of regimen discontinuation among people on ART, the total duration of follow-up for the whole cohort in person-year (PY) was used.The follow-up duration for people on ART who did not discontinue their initial regimen was calculated from the time of initiation of ART until the last visit. For patients who discontinued their initial regimen, the follow-up duration was calculated from the initiation of HAART to the substitution of at least one drug from the original regimen. Subsequently, the number of cases who discontinued their initial regimen within the cohort was divided by the total initial regimen discontinuation free follow-up duration and reported per 100 person-years.The survival analysis technique was carried out as this study considered time-to-event data and the Cox proportional hazard model was fitted. The Kaplan–Meier curve has been used to estimate the median duration of survival with an initial regimen and to compare the survival curves. Both the bivariable and multivariable Cox proportional hazard models were used to identify the predictors. Variables with a p-value of less than 0.2 in the bivariable analysis were entered into the multivariable proportional hazard model. The hazard ratio's 95% confidence interval (CI) was calculated, and variables with a p-value of less than 0.05 in the multivariable Cox proportional hazards model were considered significantly and independently associated with the dependent variable. The Cox proportional hazards model fitness was checked using the Schoenfeld residuals test.Four hundred eighteen 418) records were analyzed. The mean age at the initiation of ART was 31.9 ± 11.5 years. More than half of the respondents, 248 (59.3%), were female, and the majority, 380 (90.9%), were Orthodox Christians. The majority, 318 (76.1%), of the respondents were urban dwellers. Regarding marital status, 181 (43.3%) of respondents were married, and 122 (29.2%), 101 (24.2%) of respondents were single and divorced, respectively. Two hundred eighty-one (67.2%) of the study participants had occupation; among which 97 (23.2%), 82 (19.6), 49 (11.7%), and 53 (12.7%) were civil servants, merchants, farmers, and daily laborers respectively. A total of 193 (46.2%) patients had disclosed their HIV status to their family or other relatives. Three hundred eighty-nine of the study subjects (93.1%) did not use any substance , had working functional status, while 41 (9.8%) were ambulatory, and 15 (3.6%) were bedridden at the initiation of the initial HAART regimen. The mean weight of the participants was 51.58 ± 13.8 kg. The predominant HAART regimen initially prescribed for them was a combination of Tenofovir, Lamivudine, and Efavirenz (TDF-3TC-EFV), which accounted for 264 (63.2%) of cases, followed by Zidovudine, Lamivudine, and Efavirenz (AZT-3TC-EFV) with 72 (17.2%) cases. One hundred eighty-six (44.5%) were in WHO clinical stage I at the initiation of HAART, while 77 (18.4%), 76 (18.2%), and 79 (18.9%) were in stage two, three, and four at baseline, respectively.3, followed by 97 (23.2%) within the category of 200–349 cells/mm3. About 307 (73.4%) of study subjects initiated HAART at the HGB level of ≥ 13 g/dl. Nearly 25.6% of the patients started by taking more than one ART pill/day, and 222 (53.1%) of the participants have taken Co-trimoxazole preventive therapy Prophylaxis. Nearly 84% of the study participants had good adherence status before initial HAART discontinuation. Eighty-three (19.9%) of study subjects had Tuberculosis infection while on ART, and nearly 28.7% of participants had co-medication history other than cotrimoxazole preventive therapy  of participants had greater than 350 cells/mmed by 97 3.2% withA total of 418 study participants were followed retrospectively for the last 5 years, with 144 (34.4%) having an event and 274 (65.6%) being censored, with 140 (51.1%) still alive and on their initial regimen, 41 (14.9%) lost to follow up, 65 (23.8%) transferred out, and 28 (10.2%) dead. The study subjects had experienced an event in 863.3 person-years (PY) of observations.The overall incidence rate of HAART discontinuation was 16.7/100 person-years, and the highest incidence was at second and third years. Thirty (20.8%), 45 (31.2%), 49 (34%),14 (9.7%), and 6 (4.1%) initial HAART discontinuation occurred within the first year, second years, third years, fourth years, and fifth years of the initial HAART discontinuation, respectively. The overall median survival time of the patients was 3.5 years (IQR = 2.9–4.1 years). The cumulative probability of survival without an event at one, two, three, and four years was 0.91, 0.75, 0.54, and 0.46 years, respectively  of the total study subjects experienced initial HAART discontinuation. From these events, 30 (20.8%) occurred within the first year, 45 (31.25%) occurred in the second year, 49 (34%) in the third year, and the remaining 14 (9.7%) and 6 (4.16%) in the fourth and fifth years, respectively. In addition, the overall incidence of initial HAART discontinuation was 16.7/100 PY.In this study, the incidence was highest after 1 year of follow-up, which is in line with the study conducted in southwest Ethiopia, with a 24.2% and 31.2% incidence of initial HAART discontinuation in the second and third years, respectively, and northwest Ethiopia (Gondar), where the majority (90.9%) cumulative incidence of initial HAART discontinuation occurred in the third year . HoweverThe quantity of ART pills taken per day was found to be an independent predictor of initial HAART discontinuation in the current study. When compared to patients who took one pill per day, those who took more than one pill per day were 4.1 times more likely to discontinue their initial regimen sooner. This finding is consistent with two studies conducted in the United States, in which patients treated with more than one pill per day were associated with a higher risk of discontinuation (HR = 3.44) . Taking 3, and those who had between 100 and 199 cells/mm3 were 2.6 times and 2.3 times at higher risk of experiencing initial HAART discontinuation, respectively, when compared with those with a CD4 count of ≥ 350 cells/mm3. This finding is similar to the studies done in West Africa, Kenya, the Netherlands, Canada, Peru, England (London) [Those patients who had a low CD4 count at the initiation of ART have a higher risk of experiencing initial HAART discontinuation. Patients who had a CD4 count of < 100 cells/mm(London) –15. Diff(London) .Patients who had started HAART at baseline WHO clinical stages III and IV were nearly 2.6 times and 2.68 times at higher risk of discontinuing their initial regimen, respectively, as compared to those with WHO clinical stage I. This finding is similar to studies done in Switzerland and two Kenyan studies , 2, 18. Those who had developed TB on the initial HAART regimen were nearly 2.3 times more at risk of discontinuing their initial regimen at any time, as compared to those who had not developed TB. This study was supported by a study done in India and Ethiopia , 5, 20, A retrospective review of medical records may miss information that was not documented appropriately by the provider.The incidence of initial HAART regimen discontinuation was found to be high, and most of the discontinuations occurred after 1 year of the initiation of HAART, with a median survival time of 3.5 years. Having WHO clinical stage III or IV at the initiation of ART, having TB infection on the initial regimen, baseline CD4 count, and taking more than one ART pill per day were found to be predictors for time to initial HAART regimen discontinuation in the cohort of patients at Felege Hiwot comprehensive specialized hospital.Every service point should give special attention to patients who have advanced disease . The test and treat strategy should be strengthened up to the community level to prevent the advancement of the disease.ART service providers should initiate patients with the latest and most stable triple-fixed combination regimens that can be taken once daily. So Felege Hiwot comprehensive specialized hospital and other responsible stakeholders are expected to introduce alternative one-pill regimen preparations that lessen the pill burden.TB and ART service providers should work in collaboration to reduce the tuberculosis burden on people living with HIV.


The Democratic Republic of the Congo adopted the integrase inhibitor dolutegravir (DTG) as part of its preferred first-line HIV treatment regimen in 2019. This study aimed to identify predictors of viral non-suppression among HIV-infected patients under a DTG-based regimen in the context of ongoing armed conflict since 2017 in the city of Bunia in the DRC. We conducted a cohort study of 468 patients living with HIV under DTG in all health facilities in Bunia. We calculated the proportion of participants with an HIV RNA of below 50 copies per milliliter. About three in four patients (72.8%) in this cohort had a viral load (VL) of <50 copies/mL after 6–12 months. After controlling for the effect of other covariates, the likelihood of having non-suppression remained significantly lower among the 25–34 age group and self-reported naïve patients with a baseline VL of ≥50 copies/mL. The likelihood of having non-suppression remained significantly higher among those who were at advanced stages of the disease, those with abnormal serum creatinine, those with high baseline HIV viremia over 1000 copies/mL, and the Sudanese ethnic group compared to the reference groups. This study suggests that we should better evaluate adherence, especially among adolescents and economically vulnerable populations, such as the Sudanese ethnic group in the city of Bunia. This suggests that an awareness of the potential effects of DTG and tenofovir is important for providers who take care of HIV-positive patients using antiretroviral therapy (ART), especially those with abnormal serum creatinine levels before starting treatment. Even with the discovery of treatment, HIV infection remains a major public health problem in the world. Despite the proven efficacy of triple therapy with tenofovir, lamivudine, and dolutegravir TDF + 3TC + DTG), predicting resistance and adverse events in patients on this regimen is a necessity to monitor virological failure (VF) ,2, especTC + DTG,Bunia is a conflict setting, and dolutegravir (DTG) was introduced there in July 2019. The standard first line of ART initiation used before included the combination of Tenofovir (TDF), Lamivudine (3TC), and Efavirenz (EFV) (TDF + 3TC + EFV) as first-line treatment, followed by Zidovudine (AZT), Lamivudine (3TC), and Nevirapine (NVP) (AZT + 3TC + NVP), and the combination of Tenofovir (TDF) with Lamivudine (3TC) (TDF + 3TC) in combination with Nevirapine (NVP) as an alternative regimen. Conflict-affected and displaced populations face major challenges in terms of access to health facilities, food security, and good adherence to ART and treatment outcomes ,15. For Studies have shown that DTG develops a resistance of about 1% and can prevent the kidneys from releasing creatinine waste products in the urine without impacting renal function ,17,18. TBetween July 2019 and July 2021, we conducted an observational prospective cohort study of 468 patients living with HIV under DTG in all health facilities in Bunia. Bunia is a city located in the eastern part of the DRC. The city has seen armed conflict since 2017, and there are still areas where the conflict continues to this day. We included in this study patients who were aged 18 or older.Upon inclusion, participants were switched to a regimen of DTG (50 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg), which were all taken orally once daily. Thereafter, scheduled visits to assess the patients’ viral loads were performed at six-month intervals. During all visits, participants underwent medical evaluation, including physical examination, reporting of adverse events, review of concomitant medications, as well as HIV-1 RNA viral load, hemogram, liver, urine, and renal function tests.The questionnaire was designed to gather sociological and ethnical data from the participants. Trained interviewers from the research team conducted the data collection. After pre-testing the first 10 patients, the questions were checked for consistency and modified as necessary. Designated supervisors monitored the data collection to ensure the validity and consistency of the data, as well as compliance with ethical guidelines.The following information was collected: socio-demographic characteristics , clinical characteristics , and biological characteristics (serum creatinine at baseline). Exposition time under the DTG-based regimen in months is the duration from initiation of the DTG-based regimen to the day when the blood samples were collected to assess viral loads. Serum creatinine values above 1.5 mg/dL in men and above 1.37 mg/dL in women were considered high .The primary outcome was the proportion of patients with a viral load below 50 copies per milliliter after 6 months. Not all patients were able to take a viral load sample after six months. Virological suppression was defined as an HIV RNA viral load of less than 50 copies/mL . Status We analyzed the proportion of participants with an HIV RNA below 50 copies per mL. Since viral load is influenced by the duration of treatment, we adjusted the viral response according to the duration of treatment under the DTG-based regimen.Descriptive analysis of the individuals’ characteristics was performed using frequency tables for the categorical variables and for the mean and standard deviation of the patients’ ages. Differences in socio-demographic and clinical characteristics according to prior history of ART (ART naïve vs. those who were previously under ART) were assessed using the t-test for continuous variables and the chi-squared test for the independence of the categorical variables.p < 0.05. All tests were performed using Stata software .We compared viral suppression by referring to the background characteristics of the patients under DTG using the chi-squared test. We used a logistic regression model to identify predictors of virological non-suppression. Gender, age, education, marital status, ethnic group, residence, serum creatinine levels, stage of disease, tobacco history, viral load at baseline, status of treatment before enrollment, and time under the DTG-based regimen in months were introduced into a logistic model to identify the predictors of viral non-suppression. Multicollinearity was assessed using variance inflation factors (VIF) greater than 4.0 and found to be insignificant—the mean VIF was 1.91. All tests were two-sided, and the level of significance was set to The study protocol was approved by the Institutional Review Board of the Ethics Committee for Research Subjects at the Kinshasa University School of Public Health (No App: ESP/CE/094/2018 of 9 August 2018). All participants provided written informed consent prior to participation in the study. However, patients’ records/information were anonymized and de-identified prior to the analysis.The background characteristics of the participants are shown in In this cohort, more than one-fourth (28.8% (135)) were lost to follow-ups (LTFU) during the study period, and the mortality rate was 5.0% . A totalThe baseline characteristics of the individuals with available viral loads are presented in There were 305 records that included viral load results at 6–12 months. Nearly three in four patients were virally suppressed at 6 to 12 months (72.8%). About one-fourth  of the participants had a VL of ≥50 copies/mL after the follow-up period. The proportion of participants with a VL of ≥50 copies/mL was highest among the Sudanese ethnic group, with about 55.6% of these individuals failing viral suppression. Patients with abnormal serum creatinine levels had a higher likelihood of having a VL of ≥50 copies/mL compared to those who had normal serum creatinine levels. The viral response was significantly lower among participants at an advanced stage of the disease . Although they had a viral load of less than 50 copies/mL at baseline, 30.8% of the self-reported naïve patients with a baseline VL of <50 copies/mL had a viral load over 50 copies/mL at 6–12 months after the initiation of the DTG-based regimen.This study is the first in the DRC to examine predictors of non-suppression among PLHIV on DTG in Bunia, a city that has been experiencing the ongoing effects of armed conflict for more than five years. About three in four patients (72.8%) in this cohort had a VL of <50 copies/mL after 6–12 months. A previous study reporting viral suppression used a cut-off VL of ≥1000 copies/mL  ; howeverIn this study, patients with abnormal serum creatinine levels at baseline were more likely to have a viral load of ≥50 copies/mL compared to those with normal serum creatinine levels at enrollment. In a previous study, DTG caused a significant decrease in the glomerular filtration rate in PLHIV without changes in the other renal markers studied, despite the presence of tenofovir . AnotherAs expected, the viral response was poorest in patients with advanced disease (stages III and IV). Our results are consistent with a previous study showing that patients with advanced disease are more likely to have side effects, including a detectable viral load . UnfortuThe probability of having viral non-suppression remained significantly lower in older patients compared to adolescents, particularly among those in the 25–34 age group. As previous studies have also reported, the likelihood of having viral non-suppression is significantly lower in adolescents ,32,33. PThe other group of patients with a poor viral response were the Sudanese ethnic group. The proportion of participants with a viral load of ≥50 copies/mL was about 55% among the Sudanese ethnic group, and the probability of viral non-suppression remained significantly higher among them than among other ethnicities. We believe that the socio-economic and cultural situation of the Sudanese population living in the city of Bunia, coupled with the disruption of economic accessibility for the majority of them ,39, expoThis study has several limitations. First is the possibility of misclassifying the patients’ status of treatment before enrollment, which the participants may have incorrectly disclosed. Some patients were self-declared naïve when they had an undetectable viral load. Some patients on ART who changed treatment sites did not disclose their treatment status (former ART case) to the new providers for fear of being stigmatized. In a previous study, 19.4% of patients on ART did not disclose their status to family and friends . The stuIt is difficult to testify about the viral rebound among patients who were self-declared naïve but had a viral load of less than 50 copies/mL and who ended up with a viral load of more than 50 copies after 6 months under the new regimen. Patients who did not disclose their HIV status with their family in the previous study had a higher likelihood of being lost to follow-ups . Thus, pThis study suggests that we should better evaluate adherence to ART treatment in HIV patients, especially among adolescents and economically vulnerable populations, such as the Sudanese ethnic group in the city of Bunia. This also suggests that an awareness of the potential effect of DTG and tenofovir is important for providers who take care of HIV-positive patients who are on ART, especially those with abnormal serum creatinine levels before starting treatment.