Human immunodeficiency virus (HIV) infected individuals are prone to opportunistic infections (OIs) due to HIV mediated immune suppression. When opportunistic infections occur in the form of relapse or reinfection, it is said to be reoccurrence. This study was aimed to assess Incidence and predictors of reoccurrence of opportunistic infections among adult people living with HIV (PLHIV) attending ART clinics in Arba Minch Town, Southern EthiopiaThis retrospective cohort study was conducted on 450 HIV/AIDS patients attending anti-retro viral therapy (ART) clinics in Arba Minch town, southern Ethiopia. Simple random sampling technique was used. Kaplan-Meier graph and log rank test were used for group wise comparison. Bivariate and multivariable Cox Proportional Hazard Regression model were used to identify independent predictors of reoccurrence of opportunistic infection.One hundred nineteen HIV/AIDS patient had reoccurrence of opportunistic infection. The incidence rate was 11.5 per 1000 person months. The mean time of reoccurrence was 56 months. One of the most reoccurred OIs was pulmonary tuberculosis (PTB). Predictors that were associated significantly were recent cell differentiation 4 (CD4) count, recent body mass index (BMI), recent functional status, and duration on anti-retroviral therapy (ART).Though the incidence rate of OIs decreased from previous findings, attention should be given to HIV patients with low CD4 count, low BMI and for those bedridden patients. Having claimed more than 32 million lives so far, Human immunodeficiency virus (HIV) continues to be a major global public health issue. There were approximately 37.9 million people living with HIV (PLHIV) at the end of 2018 [Human immunodeficiency virus positive individuals are prone to opportunistic infections (OIs) due to HIV mediated immune suppression . When thThe same is true for other opportunistic upper respiratory tract infectious diseases. For instance, HIV patients who are infected with recurrent upper respiratory bacterial and viral infections, even if the infection can be cured spontaneously or with treatment, no protective immunity is built. Thus, patients that are cured at the end of therapy can be infected with a new strain, and might be still at risk to develop severe and complicated diseases . LikewisIn Ethiopia, according to a hospital based study conducted in Debre Markos, the overall recurrence rate of OI was 75%, and the most common OIs were recurrent upper respiratory tract infection, chronic diarrhea, and pneumonia. Poor health care facility with regard to OIs treatment, poor adherence to anti-retroviral therapy (ART), inaccessible OI prophylaxis, presence of anemia, clinical stage of the disease, and low cell differentiation 4 (CD4) count makes the problem worse. These factors were also significant predictors for reoccurrence of OIs in this facility based study .As far as our knowledge is concerned, little is known about the reoccurrence of opportunistic infections among HIV/AIDS patients attending ART in the study area. This study incorporates variables like duration on ART and regimen change, which previous studies did not address.A facility based retrospective cohort study design was applied by reviewing medical records of HIV/AIDS patients on ART.Arba Minch town is located in Gamo zone, South Western Ethiopia. Arba Minch town has two sub cities, namely Secha and Sikela. The town has four public health facilities; Arba Minch General Hospital, Secha Health Center, Arba Minch Health Center, and Weze Health Center. The first three of these public health facilities provide ART service to HIV/AIDS patients. These public health facilities treat HIV patients with “test and treat” treatment protocol in their ART center as per national treatment guideline, which was introduced three years ago at national level. These three public health facilities, which provides ART service, were purposively included into the study. The study was conducted from 5 April, 2020 to15 August, 2020.All adult HIV/AIDS patient on ART follow up from September 11, 2013 to September 15, 2018 and who were previously diagnosed for opportunistic infection.Based on the finding from the previous study, the sample size for current study was calculated. Magnitude of reoccurrence of OI was 75%  with 1.9This study includes HIV/AIDS patients who were enrolled into ART clinic from September 2013 up to September 2018. There were 830 HIV/AIDS patients who had previously diagnosed and completed treatment for any of WHO categorized OIs. Sampling frame was prepared for record of these 830 HIV/AIDS patients. For selecting study units, numerical codes were given, and computer generated simple random sampling method was applied. The final sample size was drawn by proportionally allocating the sample based on client flow at respective health facilities . The actData collection checklist was prepared by looking Ethiopian federal ministry of health (FMOH) guideline and individual patient card. The checklist consists of socio-demographic, behavioral, functional status, and clinical and laboratory related variables. Individuals who had opportunistic infection within 6 months of ART initiation were recruited, and the follow up time started from the period of treatment completion of the preceding OI. Thus, HIV/AIDS patients who started ART from September 2013 and who had baseline opportunistic infections will be recruited into the study, and the recruitment will end on September 2018. Recent measurement of variables was considered 6 months before either of reoccurrence, end of follow up, loss to follow up, death, and transfer out was happened. Reoccurrence was measured by reviewing individual patient card for OIs. Those who were on treatment, loss to follow up, died and transfer out during the follow up were considered censored. Based on information from patients’ medical record, clinical and laboratory screening were made to identify possible opportunistic infections; for instance, screening of HIV/AIDS patients for PTB was made by using clinical examination and GeneXpert. For diseases like cryptococcal meningitis, screening was made with lumbar puncture and cerebro-spinal fluid (CSF) analysis. Both the minimum and the maximum follow-up time after completing treatment of initial OI were one year and six and half year.We discussed the data collection process with public health facilities’ management and ART clinics’ coordinator. Data collectors were 6 BSc nurses who have experience and training on ART service. Three-day training was given for data collectors. Patients’ card were collected from card room, and sampling frame was prepared for those who had previous OIs. Data was collected from 8 April, 2020 to 20 April, 2020.Reoccurrence: diagnosing of one or more opportunistic infection after treating previous OI.Censored: patient who were loss to follow up, transfer out, complete the study, and died were considered censored.Time: time until reoccurrence of opportunistic infection.Good Adherence: if PLHIV adherent > 95% that is the percentage of missed dose is < 2 doses of 30 doses or <3 dose of 60 dose) as documented by ART health personnel.Fair Adherence: if PLHIV adherent 85–94% that is the percentage of missed dose are 3–5 doses of 30 doses or 3–9 dose of 60 dose) as documented by ART health personnel.Poor Adherence: if PLHIV adherent <85% that is the percentage of missed dose is > 6 doses of 30 doses or >9 dose of 60 dose) as documented by ART health personnel.The data was coded and double entered into Epi data version 3.1, and then it was exported to STATA version 14 . Before analysis, some continuous variables were changed to categorical variables based on previous studies. Kaplan-Meier survival estimation was done to show time until free of reoccurrence of OIs. Life table was also constructed for the entire cohort of 450 HIV/AIDS patients. Comparison between groups was made by Kaplan-Meier survival curve and log rank test. Assumption of observational independence with cut off value of 10 for variance inflation factor (VIF) was done. Variables like baseline and recent hemoglobin, baseline and recent body mass index (BMI), and baseline and recent CD4 count were checked; there was no multi-collinearity between predictor variables. Finally, assumption of proportional hazard was checked by goodness-of-fit statistical test. Non-significant chi square was considered for not violating the proportional hazard assumption. The statistical significance and strength of the association between independent variable and an outcome variable was measured by bivariate Cox regression model. From this, a variable P value less than 0.2 was transferred to multivariable Cox regression model to adjust confounders’ effects. Model was built and compared by stepwise backwards elimination procedure and likelihood ratio test. A p value less than 0.05 was considered as significantly associated in the final model. Cox-Snell residual was compared against cumulative hazard function to check whether or not the model was fit.To maintain data quality, training was given for data collectors on objectives of the study, data collection procedure, and confidentiality of the data collection process. Advisors and principal investigator were supervising the data collectors. Incompletely recorded follow up formats were excluded from abstraction. Five percent of the sample was randomly selected and the data were re-abstracted by the supervisor to check the reliability and consistency of data and accordingly correction was made. In addition, at the end of data entry, data cleaning was done using frequencies, cross tabulations, sorting, and listing to check missed values and outliers. Errors identified were corrected by revising the original abstracted format.A letter of clearance was obtained from institutional research ethics review board (IRB) of Arba Minch University, College of Medicine and Health Science, school of public health. We had been given verbal approval from Arba Minch General Hospital and health centers administration and ART coordinator after explaining the purpose of the study. We also assured that the confidentiality of record review will be kept and no exposition of data at individual level.The research supervisors and the hospital and health centers ART clinics staffs witnessed the consent process. As this is retrospective document review, we did not receive informed consent from patients. In order to keep the confidentiality of information obtained, we only use medical record number of individual patients to retrieved data from the health institutions data base; we did not use name and anything that expose patient identity. Furthermore, data collectors were ART clinic staffs. So, all these measures helped us to fully anonymize the data before we accessed it.During the follow up period from Sep 11, 2013 to Mar 9, 2020, a total of 450 (91.1%) HIV patients with previous OI were followed for a median time of 19 months (Interquartile range (IQR) = 7–38). Their mean/ standard deviation (SD) age was 34.3 (±8.47). More than half (58.4%) of the study participant were females. Among the total study participant, 360 (80%) were urban resident. Two hundred fifty-nine (57.6%) were married. One hundred seventy-nine (39.8%) study participants attended primary education, followed by 114 (25. 3%) patients who don’t have formal education. Ninety-seven (21.6%) were government employee by occupation.In the study, all 450 (100%) patients who diagnosed with one or more opportunistic infections within 6 months were included. Eighty (17.8%) of HIV infected patients were diagnosed with chronic disease. Four hundred twenty-nine (95.3%) of the participant were diagnosed with one opportunistic infection at a time. The study participants’ baseline and recent BMI mean (SD) values were 20.9 (±3.32) and 23.8 (±18.5) respectively. Both baseline and end line median (IQR) CD4 count were 322.5 (183.7–427) and 441.5 (210–630) respectively. Median and IQR values for both baseline and recent hemoglobin were 12.3 (10–13.9) and 12.9 (11–14) respectively.Majority of them were taking first line regimen in both baseline and at recent visit. Among first line regimen, Tenofovir, Lamivudine and Efavirenz (TDF/3TC/EFV) were the major prescribed drug in base line and on follow up, 416 (92.4%) and 317 (70.4%) patients took these fixed combination drugs, respectively, followed by Tenofovir, Lamivudine, and Nevirapine (TDF/3TC/NVP) during base line and Tenofovir, Lamivudine and delavirdine (TDF/3TC/DTG) during follow up, which account 21 (4.7%) and 73 (16.2%) of patients took these fixed combination drugs, respectively. From OI prophylaxis given, isoniazid was the major one; 37.1% of patients took isoniazid OI prophylaxis. Two hundred fifteen (47.8%) patients were test and treat category. At baseline, 244 (54.2%) were WHO stage 3, 143 (31.8%) were WHO stage 2, and the remaining 63 (14%) were WHO stage 4 HIV patient. One hundred seven (23.8%) had Pulmonary TB, 78 (17.3%) had herpes zoster and 46 (10.2%) were infected with pneumonia and were the major occurred disease at base line. Opportunistic infection reoccurred among 119 (26.4%) HIV/AIDS patients. Based on data from  around 9Kaplan-Meier survival estimate was also conducted for cohort of 450 study participant . The graThe mean survival time of cohort of 450 HIV/AIDS patients was 52.8 person months. The minimum, the maximum, and the total months taken for the reoccurrence of OI were 1, 78 and 10329 person months respectively. One hundred nineteen patients had reoccurrence of opportunistic infection, with incidence rate of 11.5 (95% CI: 9.6–13) per 1000 person months. The cumulative probability of surviving until 60 months was 52%. Based on data from the life table, around 92 (77%) cases were reoccurred within 24 months’ period. Those variables that were significantly associated with reoccurrence at P- value of ≤ .2 in bivariate analyses were transferred to multivariable analysis. Variables that were associated include base line chronic disease, number of opportunistic infections at base line, base line and recent functional status, base line and recent WHO clinical stage, base line and recent hemoglobin level, and base line and recent CD4 count. In multivariable Cox regression, backward model building method was used until we got statistically significant predators at p-value of ≤.05. After adjusting for confounding effect of covariates, the following variables were significantly associated with the reoccurrence of opportunistic infections. One of the factors which improve the survival probability was body mass index (BMI). Those patients who had BMI of ≥18.5 were 0.46 times less risky (p = 0.039) at any instantaneous point of time as compared to patients with BMI of <16. Those HIV/AIDS patients with CD4 count of >350 were 0.77 times less risky (p = 0.000) at any given time than those patient with CD4 count of <200. Both ambulatory and bedridden functional status patients were 2.3 and 3.4 times high risk (p = 0.008 and p = 0.000) respectively at any given point of time as compared to working functional status. Duration of ART was another significant predictor, in which those who took ART up to three years and more than three years were 0.75 and 0.91 times less risky (p = 0.000 and p = 0.000) respectively at any given point of time as compared to those who took less than one year. In this study, from a total of 494 HIV/AIDS patient records, we analyzed 450 (91.1%) complete records. HIV patients with previous OI were followed for a median time of 19 months (IQR = 7–38). This retrospective cohort study found that 119 patients had reoccurrence of opportunistic infections, with incidence rate of 11.5 (95% CI: 9.6–13) per 1000 person months. OIs reoccurred among 119 (26.4%) HIV/AIDS patients on ART. This finding showed that lower proportion of PLHIV had OIs as compared to previous study conducted on similar topic [Hunde G [On this study, recent CD4 level was significantly associated with reoccurrence of OI. This finding is in line with other several literatures –16. All Hunde G . On anotHunde G . Based oHunde G . This miBut, as a clinical factor, both base line and recent WHO clinical stage were not significantly associated with reoccurrence of OI as with most of the reviewed literature have showed significant association , 18, 20.As a limitation, this study was affected by incompleteness of patient record. In order to solve this problem, we remove incomplete records from abstraction and adjust the sample size to predict the effect that was really existed.This study showed that lower proportion of PLHIV had reoccurrence of OIs as compared to the previous institutional based study. But, as this is incidence study, even a small number of cases have an impact to the larger population group. Predictor factors that were associated with the reoccurrence of OIs include; recent functional status, which was positive factor for the reoccurrence. Recent CD4+ count, recent BMI and duration on ART were negative predictors associated significantly and again were also protective against the reoccurrence.


DT started within 7 days of first specialist consultation in all patients and the same day in 84.1%; 3.4% had baseline resistance mutations ; 12.5% were lost to follow-up. At week 48, 86.3% had VL < 50 cop/uL by intention-to-treat analysis and 98.7% by per-protocol (PP) analysis. Virological failure (VF) was recorded in 1.1%, with no resistance mutation. One blip was detected in 5.2% without VF. Three reported anxiety, dizziness, and cephalgia, respectively, at week 4 and one reported insomnia at week 24; none reported adverse events at week 48. The mean weight was 4 kg higher at 48 weeks (p = 0.0001) and abdominal circumference 3 cm larger at 24 weeks (p = 0.022). No forgetfulness occurred in 98.7% of patients. Patient satisfaction was 90/100 at 4, 24, and 48 weeks. Conclusion: Real-world data demonstrate that dolutegravir plus lamivudine in MTR is effective, safe, and satisfactory, moderately increasing weight and abdominal circumference and administrable on a test-and-treat strategy.Brief: Real-world data in naïve HIV-1 patients demonstrate that dolutegravir plus lamivudine in a multiple tablet regimen is effective, safe, and satisfactory; it causes moderately increasing weight and abdominal circumference and is administrable on a test-and-treat strategy. Background: Our objectives were to determine the real-life effectiveness and safety of DT with dolutegravir (50 mg/QD) plus lamivudine (300 mg/QD) in a multiple-tablet regimen (MTR) in naïve PLHIV followed up for 48 weeks and to evaluate the compliance and satisfaction of patients. Material and methods: An open, single-arm, multicenter, non-randomized clinical trial from May 2019 through September 2020 with a 48-week follow-up. Results: The study included 88 PLHIV patients  with a mean age of 35.9 years; 76.1% were MSM patients. The mean baseline CD4 was 516.4 cells/uL, with a viral load (VL) of 4.49 log People living with HIV (PLHIV) have experienced an exponential increase in survival and life expectancy over the past two decades thanks to antiretroviral treatment (ART). The resulting improvement in morbidity and mortality has to HIV becoming a chronic infection . Life-loReal-life studies ,11,12 anHence, the main objective of this real-life study of naïve HIV patients was to determine the effectiveness of DT with dolutegravir 50 mg/QD plus lamivudine 300 mg/QD in a multiple-tablet regimen (MTR). Our secondary objectives were: to describe the type of patient prescribed with this biotherapy, to measure the interval between first specialist consultation and DT initiation (deferred or immediate/early treatment); to evaluate its possible application in a “test-and-treat” approach; and to determine the following: gradient of the decrease in viral load (VL), increase in CD4 lymphocyte levels, type of virological failure (VF), the influence of previous mutations detected in baseline genotypic resistance tests (GRTs), the safety of the treatment, and the satisfaction of patients and their retention within the health system.STUDY DESIGN This prospective, longitudinal, post-authorization, single-arm, multicenter study consecutively included naïve HIV patients starting ART with dolutegravir 50 mg/QD and lamivudine 300 mg/QD in MTR, from May 2019 through September 2020 with a 48-week follow-up.PATIENTS: Inclusion criteria: The presence of HIV infection, age > 17 years, prescription by an attending physician of dolutegravir 50 mg/QD and lamivudine 300 mg/QD in MTR, and written informed consent to participate in the study.Exclusion criteria: Pregnancy, non-utilization of contraception in women of childbearing age, life expectancy less than the study period, the expectation by attending physician of treatment change before the study ends (not due to adverse drug effects but rather to incompatibility with other drugs to be administered to the patient), and protocol violation.Origin: The patients came from the infectious disease or internal medicine departments of 13 public hospitals in Spain.Epidemiological, clinical, and analytical data were gathered in accordance with national data protection legislation . The study complied with the principles of the Helsinki Declaration and was approved by the clinical research ethics committees of the Virgen de las Nieves University Hospital of Granada  and all other participating centers.At their baseline visit, patients were informed about the study conditions and objectives and were asked for their written consent. At the same visit, data were gathered on anthropometric variables , and blood samples were drawn for: blood count, biochemistry , CD4 and CD8 lymphocyte counts, CD4/CD8 ratio, HIV VL, GRT, and serology studies of hepatitis B virus (HBV), hepatitis A virus (HAV), hepatitis C virus (HCV), syphilis, cytomegalovirus, and toxoplasma.Data were again collected on the above anthropometric measures and blood analysis results (except for serology) during follow-up visits at weeks 4, 24, and 48, when they were also asked to report any adverse effects and to complete EQ-5D  and SMA-Effectiveness: Plasma VL < 50 cop/mL at week 48 according to intention-to-treat  and per-protocol (PP) analyses.Virological failure: Two consecutive VLs > 50 cop/mL after previously achieving non-detectability during the DT.Blip: Viral load > 50 cop/mL and <200 cop/mL after achieving undetectable VL, which is again undetectable in a test within 15 days.Deferred treatment: Initiation at ≥2 weeks after the initial specialist consultation.Test and treat strategy: Either immediate treatment on the day of the initial consultation  or early treatment, i.e., within two weeks of the initial consultation.ART dropout: Change from the DT to another ART requested by patients due to adverse effects or to their preference for a single-tablet regimen (STR), among other reasons. Losses to the follow-up are not considered in this calculation.Retention in the healthcare system: Defined by the percentage of patients who were not lost to the 48-week follow-up.2) [Classification of weight as a function of BMI (kg/m2) : UnderweMild: no antidote or treatment needed; brief hospitalization. Moderate: treatment modification required , but the DT is not discontinued; a longer stay or the addition of a specific treatment may be necessary. Severe: The adverse drug reaction is life-threatening and requires the withdrawal of the DT and the initiation of a specific treatment. Fatal: The adverse reaction directly or indirectly contributes to the patient’s death.Self-perceived quality of life: This was evaluated by the patients using the visual analog scale (VAS) of the EuroQol-5D (EQ-5D) questionnaire (score range 0–100). Results were expressed as percentages .Adherence: The simplified medication adherence questionnaire (SMAQ) was self-completed by the patients to evaluate their adherence to the ART protocol .Sample size: The sample size estimation assumed effectiveness of 92% and considered a bilateral confidence interval of 95% and an error of 10%. A final sample size of 88 individuals was selected to allow for a possible loss to follow-up of 10% .Statistical methods: In a descriptive analysis, means with standard deviations were calculated for quantitative variables that were normally distributed (by the Kolmogorov–Smirnov test), medians and percentiles for those that were not, and absolute frequencies for qualitative variables. DT effectiveness was confirmed using the FDA Snapshot algorithm, defining virological success as plasma VL < 50 cop/mL at week 48 by ITT analysis and considering VF, treatment discontinuation, or loss to the follow-up as failures. The effectiveness at week 48 was also calculated according to PP analysis, considering VF alone as a failure. IBM SPSS Statistics for Windows version 25.0  was used for data analyses.The study was recorded in ClinicalTrials.gov. Identifier: NCT04002323.10 ; 11.4% of patients were in the AIDS stage, and 1.1% had positive HBV surface and core antibodies. DT was initiated within one week of the initial specialist consultation in 100% of patients  and on the same day in 84.1%. Baseline resistance mutations  were detected in three patients (3.4%). The study included 88 people living with HIV (PLHIV). The mean age was 35.9 years; 87.5% were men, and 76.1% were men who have sex with men (MSM). The mean baseline CD4 was 516.4 cells/uL (8% had Cd4 < 200 cells/uL), and the mean VL was 4.49 logAt week 48, 86.3% of patients had VL < 50 cop/uL by ITT analysis  and 98.7% by PP analysis. The follow-up was completed by 14 of the 17 patients with baseline VL > 100,000 cop/mL, and all of them had < 50 cop/mL at week 48. One patient (1.1%) had VF at week 48 due to poor adherence, with no GRT-detected mutations. He was then prescribed tenofovir-alafenamide/emtricitabine/bictegravir, although non-detectability was not achieved, and he had plasma VLs of 215 cop/uL and 183 cop/mL during the 24 weeks after its initiation; this patient showed no mutations in a new GRT. His ART was again changed, to tenofovir-alafenamide/emtricitabine/darunavir/cobicistat, showing VLs of 311 and 211 cop/mL during the 24 weeks of this treatment .During the 48-week follow-up, four patients (5.2%) had one blip, with plasma VLs of 83, 93, 97, and 109 cop/mL, respectively; none of these patients presented with VF.p = 0.0001) and continued to rise, as shown in p = 0.0001). The CD4/CD8 ratio also increased from baseline to week 48 . VL was undetectable in 70.2% of patients at week 4. The creatine level increased by only 0.1 mg/dL  from baseline to week 48, with a reduction in creatine clearance of only 9 mL/min . The mean TC increased by 19 mg/dL  from baseline to week 48, whereas there was no significant change in TC/HDL ratio  or triglyceride count  during the study period,  and their mean BMI increased from 23.8 ± 3.9 to 25.2 ± 4.43 (p = 0.0001), i.e., from normal weight at baseline to overweight at week 48. The distribution of the BMI-based classification of patients over the study period was: low weight in 3.5% at baseline vs.2.9% at week 48, p = 0.56; normal weight in 61.6% vs. 56.5%, respectively, p = 1; overweight in 29.1% vs 26.1%, respectively, p = 0.58; and obesity in 5.8% vs. 14.5%, respectively, p = 0.06 (p = 0.022).The mean weight of patients increased by 4 kg over the 48-week follow-up period  at week 4, 90 (IQR: 80–100) at week 24, and 90 (85–100) at week 48. Eleven patients (12.5%) were considered lost to the health care system.The patients in this study were predominantly young MSM with good viral and immune status, and only 11.4% had AIDS. The DT was administered within one week of the first specialist consultancy in 100% of the patients and on the same day in >80%.At the end of the 48-week follow-up, 86.3% of participants had a plasma VL < 50 cop/mL by ITT analysis and 98.7% by PP analysis. Only one patient presented with VF attributed to poor adherence; no resistance mutations were detected in this patient, likely due to the presence of moderate-low level viremia. VF was not observed in the four patients who experienced a blip. Frequent blips or plasma VL counts > 200 cop/mL are associated with a higher risk of VF and the emergence of multi-drug resistance ,22. ThisThe loss to follow up in the present study (12.5%) is also comparable with that recorded in the DIAMOND (11%) and STAT (14%) trials, despite conducting part of the enrolment and follow-up process during the SARS-CoV-2 pandemic (recruitment from May 2019 through September 2020 with 48-week follow-up), when some individuals avoided visits to the hospital for fear of contagion. This DT (dolutegravir plus lamivudine) therefore appears to be an optimal treatment to ensure that patients are retained within the health system, whether administered in STR or MTR. In addition, seven out of ten patients were non-detectable at week 4, one of the advantages of the test-and-treat strategy  and recoThe treatment produced no changes in the lipid profile of the patients, as previously observed in clinical trials of this DT in trials with naïve patients ,16 and iThe mean weight classification of the present patients changed from normal weight to overweight over the 48-week follow-up, and their waist circumference increased by 3 cm over the first 24 weeks. Most clinical trials and observational and cohort studies of integrase inhibitors as first-line ART regimens have described a weight gain in naïve HIV patients. Dolutegravir is the drug most frequently associated with this increase; however, the underlying mechanism was not established, and it is not known whether it is related to lipohypertrophy with visceral fat deposits .Despite the administration of a specific questionnaire on potential adverse events, these were very rare. In addition, the patients expressed a high level of satisfaction with the treatment, which was fully adhered to by patients who completed the follow-up. In the DIAMOND trial , only onThe present study is limited by its open, non-randomized design, similar to the only two trials that analyzed early ARV initiation in naïve HIV patients. However, it offers a prospective longitudinal analysis of the real-life effectiveness of this DT when prescribed by HIV specialists, contributing real-world data.In conclusion, DT with dolutegravir and lamivudine in MTR is an effective, safe, and satisfactory strategy for rapid or immediate initiation and achieves a high rate of retention within the health care system. This DT increases the weight and BMI of patients who globally pass from normal weight to overweight within 48 weeks and already have a significantly expanded abdominal circumference at 24 weeks.


HIV coinfection with viral hepatitis B (HBV) or viral hepatitis C (HCV) is not uncommon in Ethiopia. Although the coinfections are presumed to interfere with antiretroviral treatment (ART), this is not widely studied in Sub-Saharan African settings. This study was conducted to determine ART retention in persons coinfected with HIV + HBV or HIV + HCV.We reviewed the medical records of HIV-positive adults who initiated ART between 2011 to 2018 in four high-burden hospitals of Addis Ababa. Retention in care was the primary outcome of the study, which was compared between HIV and either HBV or HCV coinfected persons, and HIV-monoinfected persons. A parametric Gompertz regression model was used to compare retention between the coinfected and monoinfected groups.p = 0.0048] in the monoinfected group. The cumulative retention was lower  in male coinfected patients than male monoinfected patients . In contrast, cumulative retention was similar in females in the coinfected group  versus the monoinfected group . Overall, HIV-positive with viral hepatitis coinfection were 24 and 31% less likely to still be on ART care than the monoinfected group at 12 months and overall, with sub-distribution adjusted hazard ratio (AHR) of 0.76 and 0.69 respectively.A total of 132 coinfected persons and 514 HIV-monoinfected individuals who initiated ART in 2011–2018 were compared. At 12-months of follow-up, 81.06% [95% CI: 73.3–86.9%] of the coinfected and 86.96% [95% CI: 83.7–89.6%] of the monoinfected were still on ART care. Cumulative retention in the coinfected group was 68.93% [60.4–76.3%] versus 80.35% [76.6–83.5%, oinfected individuals are less likely to stay on ART than HIV monoinfected individuals. The low retention in the coinfected group from this study may affect the success of survival gained in people living with HIV (PLHIV) in the long term. More concerted efforts need to be made to retain coinfected individuals at least at the level of monoinfected persons on long-term ART care. Future studies are needed to better understand the difference in retention, preferable in a prospective manner.We observed that cThe online version contains supplementary material available at 10.1186/s12889-022-13025-y. In the era of free antiretroviral treatment (ART), morbidity and mortality have declined in people living with HIV in resource-limited countries . HoweverGlobally, HBV affected an estimated 257 million people and HCV 71 million in 2015 . Viral hViral hepatitis B is endemic (9.4%) in Ethiopia in the general population . SystemaThis paper aimed to compare the ART outcomes in terms of ART retention in viral hepatitis coinfected (HBV-positive or HCV-positive) and HIV-monoinfected (without HBV and HCV) individuals in Addis Ababa, Ethiopia.This study utilized a retrospective cohort study design. The study compared ART outcomes  between coinfections (HBV or HCV) and monoinfection groups. As access to viral hepatitis testing in Ethiopia is low, we conducted our study in four health facilities where there was a better availability of viral hepatitis testing.The four study facilities are considered high-HIV-burden hospitals (three public and one private) in Addis Ababa and testing facilities were better organized compared to other health facilities.Addis Ababa is the capital city of Ethiopia and carries one-fourth of the burden of HIV in the country. An estimated 100,000 HIV-positive persons were receiving ART at the end of 2019 in the city . A free Comprehensive HIV care, treatment, and prevention services are provided based on the national guidelines adopted from WHO recommendations. Until 2016, ART initiation was based on CD4 cell/mL counts: < 200 CD4 cells/mL from year 2005–2010, < 350 CD4 cells/mL from 2011 to 2013, and < 500 CD4 cells/mL from 2014 to 2016 . In 2016All medical care was provided by a team of physicians, nurses, adherence counselors, and pharmacists. Adherence counseling and patient tracing for lost-to-follow-up patients were supported by expert patients (HIV positive). Tracing lost-to-follow-up patients was mostly done by telephone follow-up. Full-time data clerks and a data manager supported the clinical team in handling the recording and reporting of patient data. Patients newly on ART were monitored monthly until they became stable. Once they were stable and willing, they were given an appointment spacing where they could take their drug every three to 6 months instead of monthly. In most facilities, patients received their refill drug at the ART clinic during their monthly or quarterly visits. There was a linkage between the ART clinic and pharmacy prescription records that confirmed patients picked up their drugs.The standard first-line treatment option for HIV + HBV coinfection was the tenofovir-based combination regimen, which acts against both HIV and HBV. The WHO recommends direct-acting-drugs (DADs) for treating chronic HCV-coinfected patients. However, DAD is very expensive, and treatment services are not available in most ART health facilities, including the study facilities of Addis Ababa. So, HCV coinfection patients in our data is lacking information on HCV treatment.The study population comprised PLHIV who started on ART between September 2011 and December 2018. Participants were included if they were aged 15 or older and had documented viral hepatitis B surface antigen and viral hepatitis C antibody test results, regardless of whether the result of viral hepatitis B and C was positive or negative. Accordingly, of the total 3006 eligible in the four study health facilities we were able to include 2031 in our analysis.Retention:Retention at 12 months: individuals who were alive and still taking ART 12 months after ART initiation.Cumulative retention: individuals who were alive and on ART for the whole follow-up period .Alive and on ART (still on ART): patients who picked up their last eligible drug dose of the study period from an ART clinic/pharmacy. Patient drug pick-up was updated on follow-up cards and ART cohort registers monthly based on the patient’s monthly status.Lost to follow-up (LTFU): missing of three consecutive clinic visits (drug not picked up for 3 months or 90 days). This is captured from the patient cohort follow-up card and ART cohort register which were updated based on monthly patient status.LTFU at 12 months: individuals who had missed their clinic visits for three consecutive scheduled visits (90 days) at 12 months after ART initiation. Cumulative LTFU: individuals who missed their drug pick-up for three consecutive scheduled visits (90 days) at any time in follow-up period.Death: Confirmed hospital deaths were reported in the ART register and patient’s follow-up cards.Death at 12 months: individuals who were reported dead at 12 months after ART initiationCumulative death: individuals who were reported dead after ART initiation at any time in follow-up period.Knowing the timing of viral hepatitis HBV and HCV coinfection is essential in measuring retention on antiretroviral therapy in PLHIV. Approximately 90% of chronic HBV in the current adult population of African and Asia started with childhood infection, most likely before HIV infection . On the other hand, in the absence of an HCV RNA diagnosis, it is not possible to ascertain whether an HIV/HCV coinfection is recent. Hence, in this study, we took the date of a new HIV diagnosis as a proxy date of coinfection for either HBV or HCV.Coinfection: the presence of at least one viral hepatitis (HIV + HBV or HIV + HCV).Monoinfection: without hepatitis B and without hepatitis C viruses (HIV only).The following covariates were also considered based on our previous ART knowledge: age, sex, education, marital status, WHO clinical staging, baseline CD4 cell/mL count, tuberculosis status at baseline.A standard data abstraction form was prepared to extract individual-level data that were pertinent to meet objectives of this paper. The form had four sections a) sociodemographic information; b) HIV care information at enrollment including; date of confirmed HIV positivity, ART initiation date, and date of each outcome; c) HIV care at baseline and follow-up, including CD4 cells/mL at baseline, at 6 months, and 12 months; WHO clinical staging; functional status; hemoglobin; liver functional test; viral hepatitis status (B and C); tuberculosis status; and drug patterns; and d) outcome variables, including survival and follow-up, death, lost to follow-up, stopping treatment, and transfer out.Data abstractors were trained for 3 days by the principal investigator. The first 2 days of the training were spent on the data abstraction tools and how to abstract data ethically. On the third day of the training, the data abstraction tool was pretested in one of the hospitals. Data abstraction was done using a preloaded data form on a tablet. The ART register was used to select age 15+, ART initiation date, and unique ART number (that linked to the patient’s folder).Each patient’s folder was accessed to abstract laboratory information, including CD4 cell/mL count, viral load, ALT, AST, platelets, hemoglobin, WHO stage, viral hepatitis B and C, and monthly follow-up visit status. The nurses abstracted the clinical and laboratory data, and the data managers were responsible for direct data entry into the tablet. Extracted data were uploaded daily to the REDCAP server after being checked by a trained supervisor, and the study team provided regular supervision at the study site.A power calculation was done to ensure whether the available records would be enough to address the main objective of this study. The coinfected group was anticipated to be much smaller than the monoinfected group, as the criterion for starting ART was mainly HIV positivity. Thus, a ratio of 1 coinfected to 4 monoinfected was used. The sample size was estimated for the two outcomes , and the largest estimated sample size  is presented. Mortality in HIV + HBV (hazard rate of 1.4) and HIV + HCV (hazard ratio of 1.4) was taken from a previous study . A hazarp-values. To calculate retention, we used the last day of the study as a right censor, and events that occurred were death and loss to follow-up together. Overall, 15% of the patients were tested but had no HBV/HCV test results mentioned and excluded from the analysis. We checked potential bias by comparing demographic and clinical characteristics between patients who were tested for viral hepatitis B and C versus those without document test result and we did not find any important significant differences in demographic and clinical data . The proportion of males was significantly higher (60.61%) in the coinfected group than in the monoinfected group (43.86%) (Table We compared 132 coinfected (HIV and hepatitis) and 514 monoinfected (only HIV-positive) who started on ART during the study period . A higher median AST  and ALT  were found in the coinfected group than the monoinfected group   and monoinfected  initiated ART with CD4 cells/mL counts below 200. Similarly, more than half of the coinfected group  and monoinfected group  initiated ART at WHO stage III or IV. At baseline monoinfected individuals more often had TB  than coinfected patients . On the other hand, retention at 12 months in females in the coinfected group was, similar  to that in the monoinfected group,   in the male coinfected subgroup than in the male monoinfected subgroup,  in the male coinfected subgroup than in the male monoinfected subgroup . In contrast, cumulative retention was similar in females in the coinfected;  and the monoinfected group  .The cumulative retention in the coinfected group was 68.93% [60.4–76.3%] versus 80.35 . The cumulative LTFU was higher  in the male coinfected subgroup than in the male monoinfected subgroup . Similarly, the death rate at 12 months in the coinfected group was 5.3% (95% CI: 2.5–10.8%), higher than that in the monoinfected group, 2.91% . The cumulative death rate was higher  in the conoinfected group than that in monoinfected group  . The proportion of LTFU at the 12-month after ART started in coinfected group was 13.63% [95% CI:8.7–20.7%] versus 10.11% [95% CI: 7.7–13.0%] in monoinfected group. LTFU at 12 months was higher  in the male coinfected subgroup than in the male monoinfected subgroup, (10.66%  than the monoinfected group, 16.73% [13.4–19.9%, p = 0.0047 and x2 = 8.00  in the male subgroup of the coinfected group was higher than the cumulative attrition rate in the male subgroup of the monoinfected group with a Log-rank test equality of survival function, .00 Fig. a. In con0.00Fig. b.Fig. 3ap = 0.021), and 31% stopped ART at some time in the whole follow-up period (cumulative), with sub-distribution adjusted hazard ratio of 0.69  in the coinfected group. LTFU at 12 months was 63% higher in coinfected group, with an adjusted hazard ratio of 1.63 ; similarly, the cumulative loss during the whole follow-up period was 1.67 . On the other hand, death at 12 months in the coinfected group was 1.90-fold  than that in the monoinfected group. The cumulative death rate in the coinfected group was 2.49 times that in the coinfected group (adjusted hazard ratio 2.49 (1.02–6.10)  rate in the coinfected group could be the result of many factors. The absence of coinfected integrated prevention, care, and treatment services for viral hepatitis may lead coinfected individuals to drop out of treatment in search of viral hepatitis services which are limited to a few hospitals. The high attrition rate in the coinfected group found in this study may affect the long-term survival gained from ART in PLHIV and may affect the progress in reaching the global targets. The two previous studies in Addis Ababa showed an overall attrition rate of 21.92% (15.17% loss to follow-up and 6.5% death) . These nOur study found twofold higher mortality in the coinfected group. A comparable result was documented in a South African retrospective cohort study with a sample size of 816 . CambodiEven in countries with a much better health care system death in coinfected groups is high, a 10 year trend analysis done in France shows a result which is consistent with our finding; increased death in coinfected HIV patients than monoinfected .Our findings showed a significantly lower rate of retention in males than in females in the coinfected group. In contrast, retention was similar between males and females in the monoinfected group. The lower retention rate and the high loss to follow-up in males with viral hepatitis B or C can be explained by the fact that female HBV carriers have lower viral loads than male carriers . HBV-assThe significantly increased mean AST and ALT may lead to intolerance of ART drugs and dropout from care –33. SimiSome of the limitations of this study include the inability to control for other potential confounders, such as stage of liver disease, cause of death, adherence to a TDF-based drug regimen, and alcohol use. Viral load was selected as a covariant, however, more than 65% of the patients had no viral load test at 6 or 12 months. Due to the high level of missing values viral load was omitted from the analysis. Information on mode of HIV transmission was not available in this study. However, in Ethiopia mode of HIV transmission is primarily via heterosexual contact among adults., the reliability of the diagnostic tools remains the limitation of the study as well.The absence of HCV RNA diagnosis can increase the false positive rate of chronic HCV patients, particularly in the non-HIV population. In contrast, HBsAg underestimates chronic HBV cases because it misses occult HBV that can only be detected by HBV DNA. HenceThe loss-to-follow-up criteria of more than 3 months in this study are likely to underestimate mortality and overestimate loss to follow-up compared to other studies found , 36. As oinfected individuals are less likely stay on ART than HIV monoinfected individuals. The low retention in the coinfected group from this study may affect the success of survival gained in people living with HIV (PLHIV) in the long term. More concerted efforts need to be made to retain coinfected individuals at least at the level of monoinfected persons on long-term ART care. Future studies are needed to better understand the difference in retention, preferable in a prospective manner.We observed that cAdditional file 1.Additional file 2.Additional file 3.Additional file 4.Additional file 5.


World health organization defined adherence as the extent to which a person’s behavior – taking medications, following a diet, or executing lifestyle changes correspond with agreed recommendations from the health care provider. There is a contradiction among studies and previous studies conducted in the study area used a cross-sectional study design. This study aimed to identify determinant factors for adherence to antiretroviral treatment among people living with HIV at Dessie Referral Hospital by using an unmatched case–control study design.an institution-based unmatched case–control study design was used on a total sample of 582 (146 controls and 436 cases). Each respondent was selected by consecutive random sampling. The collected data were entered and analyzed by using Statistical Package for Social Science version 25.0. Multivariable binary logistic regression analysis was used to identify variables that were statistically significant determinants.The mean age of the respondents was 41.64 years. About 61.5% of the participants were females. Patients with baseline HIV stage I was more likely to be adherent to the prescribed HIV medicine  as compared with those with baseline WHO stage IV. Patients who did not take anti-tuberculosis medication collaterally with the prescribed HIV medicine were more likely to be adherent . Patients who took antiretroviral therapy for more than 24 months were more likely to be adherent .Initiation of antiretroviral therapy at the later stage of the disease and taking anti-tuberculosis concomitantly were negatively associated with adherence. Being on antiretroviral therapy for a longer duration has a positive association. Health facilities and professionals should strictly apply strategies for the prevention of tuberculosis among HIV patients to avoid concomitant use of anti-tuberculosis medications. Human immunodeficiency virus has a great role in the ill-health of humans worldwide. At the end of 2019, about 38.0 million people were living with HIV worldwide and 1.7 million people became newly infected. It claimed about 33 million lives so far. The larger proportion of the epidemic (25.7 million people living with HIV) was in the WHO Africa region [4 count and WHO HIV stage of the patient [Antiretroviral therapy (ART) is the act of treating a patient with the medications of HIV . Screeni patient .World health organization defined adherence as the extent to which a person’s behavior–taking medications, following a diet, and/or executing lifestyle changes corresponds with agreed recommendations from the health care provider. An extremely high level of continuous adherence to ART is very important to decrease viral replication and for better immunological and clinical outcomes .Non-adherence to the prescribed antiretroviral treatment is a major challenge in the management plan of HIV. A study done at Dessie Referral Hospital showed that about 82.3% of HIV patients on ART were adherent to their HIV medications. Another study conducted in southern Ethiopia showed that 77.10% of the respondents were adherent to the prescribed antiretroviral therapy , 7.4 cell count, substance use, and social support were identified as risk factors to be associated with the adherence status of PLWHIV for their ART [According to different studies, residence, educational level, occupation, co-morbid conditions, disclosure of HIV status, CDheir ART –10. HIV heir ART . Sub-optheir ART .World health organization and national guidelines recommended using each facility visit as an opportunity for assessing and supporting treatment adherence among people living with HIV. Viral load monitoring is considered a gold standard for assessing treatment adherence for HIV patients , 5.There is a contradiction among studies conducted regarding factors determining adherence to ART. Conducted studies in the selected area used a cross-sectional study design. Therefore, the aim of conducting this study was to identify determinant factors for adherence to antiretroviral treatment among HIV patients having follow-up at ART clinic of Dessie Referral Hospital with an unmatched case–control study design.South Wollo zone in Amhara region is bordered by North Shewa and Oromia region on the south, by East Gojjam on the west, by South Gondar on the Northwest, by north Wollo on the North, by Afar region on the northeast, and by Oromia Zone on the east. There are 20 Woredas in the zone. The administrative center of south Wollo, Dessie, is located 401 km away from the capital city of Ethiopia, Addis Ababa. Dessie referral hospital, the only referral hospital in south Wollo, is providing several services for the societies and adjacent communities outside the South Wollo zone. These services include outpatient services, inpatient services, emergency care, obstetric and gynecologic services, cancer screening and treatment, surgery, maternal and child health, and ART service. 6350 patients had a follow-up at the ART clinic of Dessie Referral hospital. Among these, 4831 were adults at the age of 18 years old and above.This study used an unmatched case–control study design to identify determinant factors for patient’s adherence to ART among patients living with HIV/AIDS. The study was conducted in March 2020.Cases: All adult patients on ART at Dessie Referral Hospital who were adherent to their HIV medications.Controls: all adult patients on ART at Dessie Referral Hospital who were poorly adherent to the prescribed HIV medicine.Cases: Randomly selected adherent adult HIV patients who were available during the data collection period.Controls: Randomly selected poorly adherent adult HIV patients who were available during the data collection period.HIV patients with the age of  ≥ 18 years and on ART for at least six months were included in the study. Those patients who came to start ART during the data collection period and those lost to follow-up patients were excluded.4 count) was used. The calculated higher sample size was 554. The final sample size became 582 by adding a non-response rate of 5% (146controlsand436cases) [The sample size for this study was calculated by double population proportion formula by using EpiInfo version 7.2.3.1 software with the consideration of 95% Confidence level, power of 80%, and control to case ratio of 1:3. The sample size was computed for each independent variable which was identified as a statistically significant determinant factor by the selected study. Then, the variable which was found to result in a higher sample size  was gathered by interviewing the patient using a structured questionnaire. First, the patient was interviewed and then after the patient exited, other data from the medical record was taken. The questionnaires were adopted after careful reviewing of different works of literature. Experts reviewed the questionnaires to check them for face validity. Adherence was assessed by a dose adherence method used by Ethiopian Federal Ministry of Health in which the percentage of doses the patient never missed in the past 30 days was calculated. This was done by number of doses taken (prescribed doses minus missed doses) divided by the number of prescribed doses and multiplied by 100 .Dependent variable: Adherence to ART.4 cell count, IPT use, BMI, duration on ART, viral load, taking anti-TB drugs.Independent variables: Sociodemographic characteristics—Age, gender, marital status, residence, educational status, occupation, monthly income, family size. Host/personal factors—Substance use , functional status. Clinical/immunological factors—opportunistic infections, DM, baseline WHO stage of HIV, baseline CDKhat: a flowering plant having an evergreen leaves which contains cathinone, a stimulant which causes excitement, loss of appetite, and euphoria.Adherence: The patient with a percentage of ≥ 95% by dose adherence scale used by Ethiopian Federal Ministry of Health was considered as adherent, and the others was considered as non-adherent .Functional status: Working – if the patient can perform his/her habitual works in or out of the house; Ambulatory – if the patient can carry out activities of daily living (ADLs); Bedridden—the patient cannot able to carry out activities of daily living (ADLs) .A pretest was done on 5% of the calculated sample size to check for the consistency of the questionnaires. First, the English version questionnaires were prepared, translated to the Amharic version, and then back-translated to the English version to check for consistency. 4 BSc nurses who have had experience at the antiretroviral therapy clinic collected the data. An MSc public health professional supervised the data collectors. Data collectors took a two-day training. The data collectors received detailed and comprehensive instructions from the principal investigator to assure the quality of the data. The filled questionnaire was checked for completeness.After confirmation of completeness and consistency of the collected data, the questionnaire was coded, entered into, and analyzed by SPSS version 25.0. Hosmer–Lemeshow goodness of fit test was checked for the entered data to evaluate the fulfillment of the assumptions for binary logistic regression and to evaluate model fitness. For each independent variable with dependent variables, bivariable binary logistic regression was done. Covariates with a p-value of ≤ 0.25 in a bivariable binary logistic regression analysis were considered eligible for multivariable binary logistic regression analysis . A variaOf 582 selected individuals, 556 were participated (417 cases and 139 controls) . The response rate for all participants became 95.5%. The response rate of cases was 95.6% and of controls was 95.2%. The mean age of the study participants was 41.64 years. About 61.5% of the participants were females. More than half, (59.3%), of the participants were married. More than half, 319(57.4%), of the respondents were Muslim. More than one quarter (28.1%) of the respondents were uneducated. More than one-third (39.7%) of the respondents were self-employed. The mean monthly income of the respondents was 2141.02 Ethiopian birr. More than half, 330(59.4%) of the respondents reside in urban areas , and controls, 126(90.6%), did not chew khat. The higher proportion of cases, 400(95.9%), and controls, 137(98.6%), were not alcohol drinkers. The majority of cases, 402(96.4%), and controls, 136(97.8%), did not smoke a cigarette , and controls, 92(66.2%), had a baseline viral load of < 1000 copies/ml , had no history of DM. The majority of cases, 343(82.3%), and controls, 109(78.4%), had no history of opportunistic infections. The respondents had a mean follow-up of 94.63 months with an SD of 39.124. While starting ART, 170(40.8%) of cases were in WHO stage I. However, a higher percentage of controls, 55(39.6%), start ART at the second stage of the disease (stage II). The respondents have had a mean baseline CD4 count of 577.08 cells/mmExplanatory variables with a p-value of < or = 0.25 in the bivariable binary logistic regression analysis were used for the computation in the multivariable logistic regression analysis.These explanatory variables were marital status, educational level, monthly income, Khat chewing, alcohol drinking, duration of taking ART, baseline WHO stage, IPT use, and being on the full course of anti-tuberculosis medications. To identify determinants that are independently associated with adherence to ART, multivariable logistic regression analysis was used. Three variables became an independent determinant for adherence to ART after adjusting the effect of other variables for the outcome.Baseline HIV stage was a statistically determinant factor for adherence to ART in which patients with baseline HIV stage I was more likely to be adherent to the prescribed HIV medicine  as compared with those patients with baseline WHO stage IV. Collateral use of the full course of anti-tuberculosis drugs was a statistically determinant factor for adherence to ART in which patients who did not take anti-TB medication were more likely to be adherent to antiretroviral therapy  as compared with those who took anti-TB medication collaterally with the prescribed HIV medicine.The duration in which the patient was on ART was a statistically determinant factor for adherence to ART in which patients who took ART for more than 24 months were more likely to be adherent to the prescribed HIV medicine  as compared with those patients who were on ART for 12 months or less  as compared with patients with baseline HIV stage IV. This is similar to a retrospective study done in northern Ethiopia in which those patients with HIV stage II, WHO stage III , and WHO stage IV  had a lower risk to be adherent to the prescribed HIV medicine as compared with HIV stage I . This maAccording to the study, being on the full course of anti-tuberculosis medications is statistically associated significantly with patients’ adherence to the prescribed HIV medicine in which HIV patients who did not take the full course of anti-TB were more likely to be adherent to antiretroviral therapy  as compared with those who did not take anti-TB medicine. A cross-sectional study done in Debre-Birhan Referral Hospital and health center also found that patients who took ART while taking traditional, complementary, and alternative medicine were less likely to be adherent to the prescribed ART  . SimilarThis study found that the duration in which the patient was on ART is statistically associated significantly with adherence to ART. Patients who took ART for more than 24 months were more likely to be adherent  as compared with those who took ART for 12 months or less. Other studies also supported that patients would be non-adherent at the early period of infection in which a study done in Nepal found that patients on antiretroviral therapy for more than three years were more likely to be adherent to ART  as compared with those on HIV for less than three years . This maQuestions related to substance use are predisposed to social desirability and recall bias which may influence the accuracy of the information. The accuracy of the information may be affected by using medical records as a source of information.This study found some factors as a determinant factor for adherence to the prescribed antiretroviral treatment. These factors include baseline HIV WHO stage, being on the combined anti-tuberculosis drugs, and the duration in which the patient was on ART. Induction of antiretroviral treatment at the advanced stage of HIV (stage IV) and being on the combined anti-tuberculosis medications were associated negatively with adherence to ART. Being on ART for a longer duration has a positive association with adherence to prescribed HIV medicine. Health facilities and professionals should strictly apply strategies for the prevention of tuberculosis among HIV patients to avoid concomitant use of anti-TB medications. Health institutions and health care providers should provide a strict and intensive adherence support for patients with advanced stage of HIV, for patients taking anti-TB drugs, and during the early days of treatment.


A better understanding of the baseline characteristics of elderly people living with HIV/AIDS (PLWHA) is relevant because the world's HIV population is ageing.This study aimed to evaluate the baseline characteristics of PLWHA aged ≥ 50years at recruitment to HIV/AIDS clinic compared against the viral load (VL) and CD4 count among patients attending Kisii Teaching and Referral Hospital (KTRH), Kenya.We retrospectively evaluated temporal inclinations of CD4 levels, viral load change and baseline demographic characteristics in the electronic records at the hospital using a mixed error-component model for 1329 PLWHA attending clinic between January 2008 and December 2019.Findings showed a significant difference in the comparison between baseline VL and WHO AIDS staging (p=0.026). Overall VL levels decreased over the period significantly by WHO AIDS staging (p<0.0001). Significant difference was observed by gender (p<0.0001), across age groups (p<0.0001) and baseline CD4 counts (p=0.003). There were significant differences in WHO staging by CD4 count >200cell/mm3 (p=0.048) and residence (p=0.001).Age, WHO AIDS staging, gender and residence are relevant parameters associated with viral load decline and CD4 count in elderly PLWHA. A noticeable VL suppression was attained confirming possible attainment of VL suppression among PLWHA under clinical care. Administration of antiretroviral therapy (ART) among human immunodeficiency virus (HIV) infected patients has led to increased survival rates among PLWHA.5There are few research findings in SSA on the indicative features of HIV infection in PLWHA aged ≥50years receiving ART.The study was conducted at HIV care clinics of KTRH.This study was a cross-sectional retrospective study using secondary electronic data obtained from HIV patients visiting an HIV/AIDS clinic at KTRH. Data on baseline CD4 count, baseline VL, last reported VL, WHO status, age, gender, marital status, the point at which individual patient source and residence was collected retrospectively from the electronic data maintained at from at KTRH.Age was categorised as 50–59/60–69/70–79/≥80 years. Age was determined based on the age of the individual at the time of enrolment to the clinic. The current residence was categorised as urban or rural as previously defined.CD4 count and viral load: The baseline CD4 cell counts were placed in four categories as previously described,16University of Eastern Africa, Baraton research ethics committee, Ministry of Health, Ministry of Education and National Commission for Science, Technology and Innovation of Kenya approved this study.Descriptive statistics were used to examine baseline CD4 count, VL and demographic characteristics. Continuous measures were compared using the Kruskal-Wallis. Wilcoxon signed-rank test was performed to compare first and last, VL counts by demographics. The p-values ≤0.05 were considered statistically significant. All analyses were performed using SAS version 9.3.Baseline CD4 counts, VL measurements and demographic characteristics of the study population were summarised .Comparison of baseline characteristics by gender was determined . StatistComparison of baseline characteristics by baseline CD4 cell count was determined . StatistComparison of baseline characteristics by WHO AIDS Staging was determined . StatistComparison of the baseline characteristics by VL change was determined . StatistWe report baseline demographic characteristics, CD4 counts and VL for PLWHA aged ≥ 50years first-time HIV testers who were ART-naive and diagnosed with HIV. Majority of the PLWHA were originally tested at the outpatient clinic. The explanation could be that most people are unwilling to test for HIV and only get a reason to test when visiting health centres where they are recommended to take HIV test and the out-patient clinic is visited by most patients who seek treatment.Overall, the HIV epidemic among the elderly who visited KTRH was dominated by adults aged 50–59years whose proportion was higher when compared to the national proportions18In the stated study period VL declined. Among the reasons for this observation is that the current ART regimens have been improved and are more comfortably endured. It is also plausible that patients with higher VL die earlier and the people who remain have lower VL.19There was a significantly higher number of females in each CD4 category which was not clear. Notwithstanding some studies suggest that the probability of late testing for HIV is higher for men compared to females.There were some limitations in our study. Data was not available for PLWHA who dropped out of care and those who were not tested. Our study did not include co-morbidities which impinge HIV treatment particularly in PLWHA aged ≥ 50years.22This study uncovered unavoidable indicative features  as associated factors to CD4 count and VL decline. Therefore CD4 count, VL, age, WHO AIDS stages, gender and residence should be utilised in solving health care challenges associated with elderly PLWHA. Additionally, Noticeable VL suppression was attained during the study period confirming possible attainment of VL suppression among elderly PLWHA under clnical care.


There are limited data to help guide implementation of differentiated HIV service delivery (DSD) in resource-limited settings in sub-Saharan Africa.This pre-implementation study sought to assess the proportion of patients eligible for DSD and HIV services utilization, as well as risk factor analysis of virologic failure in Sierra Leone.We conducted a retrospective study of adult HIV-infected patients aged 18 years and older receiving care at the largest HIV treatment center in Sierra Leone 2019–2020. Multiple logistic regression was used to identify predictors of virologic failure.3 (p = 0.009), atazanavir-based ART (p = 0.032), once monthly versus once two- or three-monthly ART dispensing (p = 0.028), history of ART switching (p = 0.02), poor adherence (p = 0.001) and not having received adherence support (p < 0.001) were independent predictors of virologic failure.Of 586 unique patients reviewed, 210 (35.8%) qualified as ‘stable’ for antiretroviral therapy (ART) delivery. There was high utilization of certain HIV service programs (e.g. HIV status disclosure to partners (83%) and treatment ‘buddy’ program participation (62.8%)), while other service programs (e.g. partner testing and community HIV support group participation) had low utilization (<50%). Of 429 patients with available viral load, 277 (64.6%) were virologically suppressed. In the multivariate logistic regression analysis of risk factors of virologic failure, CD4 < 350 cells/mmApproximately one in three HIV-infected patients on ART were eligible for DSD. We identified gaps in HIV care  that need to be addressed in preparation for full implementation of DSD in Sierra Leone. The global scale-up of antiretroviral therapy (ART) has significantly improved the survival and quality of life of people living with HIV (PLWH) . DespiteThe World Health Organization (WHO) and the International AIDS Society (IAS) have provided recommendations to guide treatment programs in LMICs adapt and diversify HIV services using ‘differentiated’ service frameworks ,5. DiffeSierra Leone is one of several LMICs in the West and Central Africa region currently undertaking activities to improve HIV care, in response to specific warnings from the WHO and IAS that this region was lagging behind others in meeting the 90–90-90 goals ,7. The nIn 2018, the National AIDS Control Program of the Ministry of Health and Sanitation of Sierra Leone released its ‘Guide of Differentiated Care Models in Sierra Leone’, which proposed various DSD models of pediatric and adult HIV care, with ART delivery to clinically stable clients identified as a priority area of focus . ImplemeThe aims of this DSD pre-implementation analysis were to (i) estimate the proportion of adult PLWH receiving care at the largest HIV treatment center in Sierra Leone who meet eligibility criteria for the proposed DSD model for ART delivery to stable clients; (ii) assess the utilization of client-centered services in an attempt to identify potential barriers to service delivery; and (iii) perform a risk factor analysis for virologic failure, an important treatment outcome measure and major criterion for DSD eligibility.We conducted a retrospective study of adult HIV-infected patients aged ≥18 years who received care at the HIV Clinic at Connaught Hospital in Freetown, Sierra Leone before the onset of the COVID-19 pandemic (October 2019 through February 2020). Connaught Hospital is a 300-bed academic facility that is affiliated with the College of Medicine and Allied Health Sciences of the University of Sierra Leone and is the country’s main referral hospital for adults. The HIV Clinic at Connaught Hospital in Freetown is the largest HIV treatment center in Sierra Leone and provides both outpatient and inpatient HIV services including partner testing and counselling, prevention of mother-to-child transmission and treatment of opportunistic infections.2, in addition to health care team not having any concerns about providing longer follow-up intervals for the patient . A . A 13]. The WHO has defined virologic failure as VL > 1000 copies/mL based on two consecutive measurements taken at least 3 months apart, with documented adherence support, after taking ART for at least 6 months . HoweverAntiretroviral drug substitution was defined as replacing one antiretroviral drug with another, while ART switching was defined as replacing the entire regimen of all three drugs. The commonest reasons recorded for ART substitution were suspected/confirmed drug toxicities and for preventing drug–drug interactions . On the other hand, ART switching was commonly carried out in the event of suspected virologic failure – HIV genotyping is currently not available in Sierra Leone to confirm the presence of drug resistance mutations.Self-reporting of missed doses, pill counts and reviewing pharmacy refill records and clinic attendance registers were used to access treatment adherence. The Adherence Index was then calculated using the formula [÷] x100%. Good adherence was defined as an adherence index > 95%.Alcohol use was defined as consuming > 20 g or 2 drinks of an alcoholic beverage daily, while illicit drug use was defined as using any quantity of any of marijuana, cocaine or injected heroin in the last 30 days.a priori, only variables that attained a p-value of <0.2 in the univariate analysis were included in the multivariate regression model. Associations were reported as crude (OR) and adjusted odds ratios (aOR) with 95% confidence intervals (CI). Differences were considered statistically significant when p was <0.05.Statistical analyses were performed using the SPSS Version 25.0 . Categorical variables were reported as frequencies (percentages) and associations assessed using Pearson’s chi-square or Fisher’s exact tests. Continuous variables were presented as medians  and associations assessed using the non-parametric independent samples Mann–Whitney U-test. A logistic regression model was used to identify predictors of virologic failure. Risk factors known to be associated with virologic failure were accessed in the univariate analysis. These included age, gender, educational level, employment status, relationship status, immunologic status (CD4 count), ART regimen based on drug class, history of ART substitution or switching, treatment duration, level of treatment adherence, targeted adherence support and counselling received, comorbidities (history of tuberculosis) and social risk factors . Other than age and gender which were included Medical records of 586 unique patient visits to the HIV Clinic at Connaught Hospital during October 2019 through February 2020 were available for review, which was representative of the 6-monthly clinic attendance rate . Of thes3 (IQR 198–509). VL was available for 82.8% (429/514) of patients, of whom 64.6% (277/429) were virologically suppressed (i.e. VL <1000 copies/mL).CD4 count was available for 62.1% (319/514) of patients screened, with a median of 322 cells/mm3; p < 0.001).Compared with unstable patients, stable patients were older , had higher BMIs  and had higher CD4 counts  of patients received ART refills monthly, while the remainder had multi-monthly refills. Compared with stable patients, the majority of unstable patients received one-monthly refills , while most patients who qualified as stable received 3-monthly refills .HIV status disclosure was high , with partner testing and HIV positivity rates of 45.1% (232/514) and 46.6% (108/232), respectively. The commonest reason for HIV status non-disclosure was fear of stigmatization .Community HIV support group participation was low , while nearly two-thirds of patients  had treatment buddies. ART adherence was estimated as high during the preceding 6 months . Nearly half of all patients received targeted adherence counselling at least once in the preceding 6 months .3 , ritonavir-boosted atazanavir (ATV/r)-based ART compared with EFV-based regimens , one-monthly versus multi-monthly ART dispensing , history of switching ART , history of poor treatment adherence  and not having received targeted adherence counselling during the preceding 6 months .This pre-implementation analysis sought to address the paucity of knowledge on HIV service delivery in Sierra Leone as the country prepares to rollout DSD models for ART. We estimated that over one-third 35.8%) of recent adult clinic attendees at the largest HIV treatment center in Sierra Leone met the eligibility criteria as stable clients for DSD. Because differentiating HIV care is a relatively new approach to service delivery in SSA, data on eligibility for DSD models are limited and difficult to compare, given that stability criteria can vary widely across different contexts and settings ,5. To fu.8% of reet al. and others [Scaling-up HIV services and optimizing clients’ access are critical to ensuring implementation success; thus, barriers that hinder these processes should be identified and addressed accordingly. Several studies from SSA have emphasized the centrality of reliable and affordable laboratory services for successful navigation of the HIV care continuum . In our d others  and was The goals of ART are to achieve and maintain durable viral suppression and restore immune function. From a prevention standpoint, sustained viral suppression is one of the most potent public health tools for interrupting the HIV transmission cycle  and limiting the emergence of drug resistance mutations ,26. To tVirologic failure remains a major barrier hindering the success of ART programs in SSA ,6. In ouAntiretroviral therapy substitution was most commonly carried out in the event of suspected HIV drug resistance (HIVDR). According to recent WHO reports, the prevalence of HIVDR is increasing globally, with countries in SSA being the worst affected . The WHO3) (37.2%) and lack of VL measurement in the preceding 12 months (14.5%). This is a substantial proportion of patients of in HIV care and are the focus of current efforts aimed at improving clinical outcomes. Our analysis of services utilization and risk factors of poor virologic outcomes offers insights into strategies that could help this large pool of clients achieve better treatment outcomes and increase the number of stable patients. These include measures to increase clinic attendance, processes to streamline VL testing for clients, increasing adherence support for patients failing on ART and multi-monthly ART dispensing. More research is needed to identify factors and processes that could improve HIV services up and virologic outcomes in this setting.Over half (52%) of clinic attendees had been on ART for more than 12 months and were otherwise well but were classified as ‘unstable clients’. The commonest reasons were elevated VL  HIV treatment center in Sierra Leone, which may limit its generalizability. Secondly, analysis of potential barriers to accessing and utilization of HIV services and virologic outcomes were not exhaustive, due to the retrospective nature of the study design and limited data available for analysis. Another limitation was that we were unable to assess the implementation, service and client outcome measures of feasibility, acceptability, adoption (uptake), cost, efficiency of service delivery and client satisfaction – all of which are integral components of effective program planning, implementation and evaluation. Nonetheless, our findings add to the limited body of research into a relatively nascent but rapidly expanding approach to effective HIV care delivery in Sierra Leone and similar resource-limited settings in West Africa.3), being on ritonavir-boosted atazanavir-based ART, one-monthly versus multi-monthly ART dispensing, history of ART switching, poor treatment adherence and not having received targeted adherence counselling. Our findings suggest that additional resources are needed to bring the program up to readiness for full DSD implementation.In this pre-implementation analysis, we estimated that about one-third of recent adult HIV clinic attendees at the largest HIV treatment center in Sierra Leone qualified as stable for ART delivery based on the proposed DSD models. While there was high utilization of certain HIV services such as HIV status disclosure and treatment buddy program participation, there was low uptake in partner testing, HIV community support group participation and targeted adherence counselling. About two-thirds of patients with available viral load in the preceding 12 months were virally suppressed. Virologic failure was predicted by low CD4 (<350 cells/mm


Azadirachta indica and Senna siamea decoction in the Northern Cameroon region and the traditionally attributed antiretroviral value, information on its efficacy and safety consumption is relevant to confirm its use. A total of 297 participants aged 18–52 and HIV-positive were recruited and divided into 3 groups: one taking only the decoction (group 1), another taking only antiretroviral therapy (ARTs) (group 2), and finally, one taking the decoction and antiretroviral (group 3). During 6 months, all the participants of the concerned groups consumed daily (morning and evening) 250 mL of Azadirachta indica and Senna siamea decoction. CD4+ and CD8+ levels were measured by flow cytometry. Hepatic and renal toxicity and oxidative stress were evaluated spectrophotometrically by measuring ALT, AST, ALP, BUN, CREAT, SOD, CAT, and GSH parameters. We note an increase in the CD4+ level of the three groups with values much more pronounced in the group treated by ARTs + decoction, from 328 ± 106 to 752 ± 140. Group 2 presented not only biological signs of hepatic and renal toxicity but also significant oxidative stress. No signs of toxicity were detected in the other groups. The study concludes that a decoction of Azadirachta indica and Senna siamea stimulates the production of CD4+ and is not toxic. On the contrary, it would reduce the toxicity caused by ARTs intake.Acquired immune deficiency syndrome (AIDS) is a major public health problem affecting several countries with predominance in black Africa. Faced with therapeutic failure caused by resistance and supply disruptions, searching for other antiretroviral agents, in particular from natural sources, becomes necessary. Given popular consumption of  Acquired immune deficiency syndrome (AIDS), caused by the human immunodeficiency virus (HIV), has been a major public health problem of global concern for several years. AIDS since its onset has already caused more than 32 million deaths worldwide. According to the World Health Organization, the total number of people living with HIV/AIDS in 2019 was approximately 38.0 million (31.6 million–44.5 million) worldwide. Africa is particularly affected by this pandemic with more than two-thirds of the number of cases or 25.7 million of these people. In Cameroon, HIV prevalence among adults was 3.6% in 2019: 5.0% among women and 2.3% among men. This corresponds to approximately 540,000 adults living with HIV in Cameroon [HIV/AIDS is managed by taking antiretroviral therapies (ARTs), which are used in various combinations commonly known as highly active retroviral therapy (HAART). Treatment with HAART promotes a sustained decrease in viral load and restoration of the immune response, as well as a reduction in morbidity and mortality from HIV infection . HoweverSince 2019, taking of ARTs is systematic in HIV/AIDS patients regardless of the clinical status and CD4+ level. Expansion of treatment access has led to several problems such as the unavailability of antiretrovirals, difficulties in laboratory monitoring, and an increased rate of treatment failure . A studyFaced with the therapeutic failure caused by resistance and the break in taming of ARTs, the search for new antiretroviral agents more effective and with low toxicity, in particular from natural sources, becomes urgent.Natural resources such as medicinal plants continue to be a common alternative for treating a variety of infectious and noninfectious diseases. It has been widely documented that medicinal plants are being used to treat HIV/AIDS with limited or no side effects . Due to An ethnobotanical study conducted in sub-Saharan Africa indicated that traditional healers and local communities widely use medicinal plants to manage the effect of HIV/AIDS in Cameroon .Thus, there is a need to discover new anti-HIV agents to supplement our current arsenal of anti-HIV drugs and to provide therapeutic options for populations with limited resources or access to currently efficacious chemotherapies. Plant-derived natural products continue to serve as a reservoir for the discovery of new medicines, including anti-HIV agents.Azadirachta indica (neem), and Senna siamea, are widely used for HIV/AIDS treatment in the community. The therapeutic virtues of Azadirachta indica and Senna siamea are strongly referenced with several activities and effects attributed to them.In the North Cameroon region, two medicinal plants, Alzohairy reports several pharmacological properties of neem which have already been demonstrated, amongst which are anticancer, immunomodulatory, antidiabetic, neuroprotective, anti-inflammatory, antiviral, antibacterial, antifungal, antioxidant, antimalarial, hepatoprotective, antinephrotoxic, and wound healing activities. However, the various studies evaluating the toxicity of neem remain controversial because some attribute toxicity to neem while others have shown its harmlessness .Azadirachta indica leaves inhibits the invasion of human lymphocytes by HIV-I and causes a significant improvement in CD4+ cell number in a small number of patients with HIV/AIDS [Clinical trials have also shown that the extract of HIV/AIDS .A double-blind clinical drug trial revealed that patients taking the drug made up of aqueous extract of neem leaves in addition to coal tar had shown a quicker and better response in comparison to the placebo group . AnotherC. siamea has antimicrobial, antimalarial, antidiabetic, anticancer, hypotensive, diuretic, antioxidant, laxative, anti-inflammatory, analgesic, antipyretic, anxiolytic, antidepressant, and sedative activities [A. indica, no studies have corroborated this activity for Senna siamea. Likewise, and to the best of our knowledge, the antiretroviral effect of the combined intake of these two plants is not known. Even more, the risks of drug interactions with conventional treatments, especially with ARTs, have never been evaluated.On the other hand, Kamagaté et al. report in a review that tivities . AlthougConsidering the popular consumption of the decoction of these two plants in the North Cameroon region and the traditional medicinal value credited, their real properties must be evaluated to confirm their use. Our study aims to not only assess the antiretroviral potential of the decoction of the 2 plants but also to assess this antiretroviral potential when the decoction is coupled with HAART.Azadirachta indica and Senna siamea for HIV/AIDS treatment. Ethics approval was obtained from the Ethical Review Board of the University of Yaoundé I, Cameroon (UY1/COET/EM/0190/19). The study confirmed to tenets of the Helsinki Declaration for human subjects in experiments. All the study participants were informed about the purpose of the study, and written consent was taken before sample collection.Participants were recruited at the approved HIV/AIDS Treatment Center (CTA) of the Garoua-Nord-Cameroon Regional Hospital and from phytotherapists residing in the city of Garoua and using the decoction of The participants were in the age group of 18–52 years, HIV-positive, and living in the collection areas. Subjects were excluded if they disclosed having other diseases such as diabetes, neurological disorders, liver dysfunction, renal dysfunction, cancer, or any other chronic condition. Participants were then classified into three groups. The first group consisted of HIV patients taking only the decoction as treatment. The second group consisted of HIV patients taking only antiretroviral therapy. The third group consisted of HIV patients taking the decoction plus antiretroviral therapy as treatment. The patients on ART were all on the first therapeutic line which constituted of ARTs tenofovir (TDF), lamivudine (3TC), efavirenz (EFV), or nelfinavir (NFV). Questionnaires were provided to collect demographic characteristics .Azadirachta indica and Senna siamea decoction, ART, or a combination of ART + decoction.The sample size was calculated using the Lorentz formula, based on the prevalence of HIV in Cameroon . The saAzadirachta indica leaves and 0.5 kg of Senna siamea leaves.Although the decoction is widely used in the community, for this study, it was directly prepared by the herbalist by boiling in 5 L of water for 15 minutes approximately 0.5 kg of The phytochemical analysis was carried out as described previously by Harborne . Based oBlood samples were taken from all participants using aseptic venipuncture and transported to the laboratory in ice bags. Four series of samples were taken. For toxicological analyses, samples were collected on day 0, after 1 month, and after 3 months. 6 months after, samples were collected for immunological analyses. The collected blood was divided into two tubes for further analysis of plasma and serum fractions, using EDTA-coated glass and plain glass tubes, respectively. The blood was centrifuged at 3500 rpm for 10 minutes at 25°C. The plasma and serum thus obtained were then stored at −80°C for subsequent analysis. The samples were analyzed at the IMPM Laboratory, Yaoundé, Cameroon, and the Center Pasteur Annex in Garoua, Cameroon.On day zero and after six months, 3 mL of blood taken from an EDTA tube was introduced into an automated device (BD FACSCount ™ system) to measure CD4+ and CD8+ in the absolute value. The cell counting method used by our automaton was based on flow cytometry as previously described .Creatinine (CREAT), blood urea nitrogen (BUN), aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) were determined with commercial kits, by enzymatic tests according to the manufacturers' protocols supplied by the kits from BIOLABO SA, Les Hautes Rives, 02160, Maizy, France. Optical densities were determined using the Kenza Automatic Biochemistry Analyzer, 450TX.Glutathione reductase (GSH) was determined by the method using Ellman reagent . Measurep < 0.05.Stata 15 and R 3.2.0 softwares were used for the statistical analysis of data. The normality of the distribution of variables was assessed using the Shapiro–Wilk test. One-way ANOVA with posthoc Tukey was carried out for comparison of hepatic, oxidative stress, and immunological parameters of different treated groups. A logistic regression model was used to establish a relationship between the different treated groups and explanatory variables . Odds ratios (OR) with 95% confidence intervals (95% CI) were calculated. The differences were considered statistically significant at Population distribution according to the sociodemographic characteristics shows that the majority of participants (60%) were between 30 and 45 years of age, average age was 35.64 years. The sex ratio  was 2.25 .Azadirachta indica extract and coumarins in Senna siamea extract  had much higher activity levels of AST and ALP than group 1 participants (decoction only) and group 3 participants (combination ART + decoction). We also note a significant decrease in CAT and GSH in the ART group compared to the other groups. After 3 months of treatment, only the creatinine remained the same. The rest of the parameters became even higher in group 2 (ART only group). There was also a significant decrease in SOD in the same group .In group 1 (decoction), only a few parameters undergo a significant increase over time (from day 0 to the end of the 3rd month). These increases include, among other parameters, catalase , SOD , and GSH  . In grouAzadirachta indica and Senna siamea has been widely consumed in the community, and many attributes its retroviral potential.Until now, HIV/AIDS has represented a real challenge for sub-Saharan African countries such as Cameroon. In these countries, for economic and sociocultural reasons and sometimes because of shortages of ARTs, alternative herbal therapies are often used by HIV/AIDS patients . Over thThe clinical and biological manifestations observed during HIV infection are due to the massive destruction of CD4+ lymphocytes. Several mechanisms are implemented to lead to the depletion of this cell population. These include the cytopathogenic effect of viruses, cytotoxic immune responses, apoptosis, and also loss of regenerative capacity of these cells by the lymphoid system .Azadirachta indica and its antiretroviral properties. Mbah et al. (2007) in a 12-week study showed that extracts of Azadirachta indica leaves administered (1 g per day) to 60 infected patients could increase the average number of CD4+ by 266 cells/μl over the study period [Azadirachta indica leaf extracts with those of highly active antiretrovirals (HAART). These results show a greater increase in CD4+ cells in patients on HAART compared to patients on Azadirachta indica [Azadirachta indica extract. When compared with previous studies, the immunostimulatory effect of the decoction of Azadirachta indica and Senna siamea is much greater. This difference could be explained by the fact that this decoction is a mixture of two plants. One with an antiretroviral-HIV activity already proven (Azadirachta indica) and the other (Senna siamea) having a good antioxidant activity, and probably, also an antiretroviral-HIV activity which, however, has never been evaluated before. The antiretroviral mechanisms of this extract remain very controversial, however. One of the most likely mechanisms is that active ingredients in plants could inhibit syncytia formation by binding to viral gp120 protein, blocking gp120-CD4+ interaction, thereby not only inhibiting HIV binding to CD4+ cells but also preventing syncytium formation (giant cell) induced by HIV [During this study, we determined the plasma concentrations of CD4+ and CD8+ lymphocytes and the CD4+/CD8+ ratio of included subjects to assess their immune capacity. Our results reveal a significant increase in the level of CD4+ in all the groups of participants after 6 months of treatment. This increase is much more significant in the group treated with ART + decoction (group 3) in comparison with the other groups . CD4+/CD8+ ratios also show an increase in all groups but remain below 1. This increase follows the same pattern as the rate of CD4+, higher in the group treated with ART + decoction. Although this decoction is highly consumed in North Cameroon, no previous scientific report has studied the effect of the consumption of this decoction on health in general and in HIV-positive patients in particular. The literature, however, is full of previous observations on y period . In 2009a indica . Mbah etd by HIV .In HIV/AIDS infection context, studies have shown that lymphocytes die of apoptosis and that all subpopulations are affected: not only CD4+ but also CD8+, monocytes, and B cells. It has also been shown that taking ARTs can be toxic to the liver and kidneys and increased oxidative stress in HIV + patients , 25. Itsrd month, group 2 (ART only) presented not only biological signs of hepatic and renal toxicity but also significant oxidative stress. On the other hand, no sign of toxicity was detected in group 1 (decoction only) and group 3 (ART + decoction). These results lead to the belief that consuming the extract is not only safe over 3 months (group 1 results) but also that the decoction could have a beneficial effect by detoxifying ARTs activity (comparing results of groups 2 and 3). This property of the decoction could be due to the antioxidant effect of different plants.In this study, from the first month of treatment and until the 3Transaminase activity is high in the group of patients treated only with ARTs, while its activity level remains the same for groups 1 and 3, both after 30 days and after 3 months. This same profile is also observed with ALP. Elevation of transaminases indicates impaired liver function or cytolysis , 30. EleAs a result of our findings, the groups treated with ART alone had lower CAT and GSH levels than the other groups. This deterioration could lead to oxidative stress, resulting in damage to cells and membranes in the renal tissue. The reversed levels after treatment with an extract or its coadministration with ART, on the other hand, suggest an antioxidative therapeutic effect against ART-induced oxidative stress through substantial enhancement of enzymatic antioxidant activities. These results are similar to those previously obtained by Zhang et al. .After 3 months of treatment, the urea level in group 2 of people treated only with ARTs is high. BUN and serum CREAT are commonly used as markers for normal biological, pathologic, or pharmacologic responses to clinical practice as markers of renal function. In ART-treated patients, we discovered substantially elevated BUN levels which can be an indicator of progressive substantial impairment in renal function. These increases in BUN concentration could have resulted from significant leakage caused by glomerular hypercellularity and tubular degradation. Treatment with the decoction significantly reduced kidney injury markers, such as BUN, preventing the development of nephrotoxicity. The attenuation of the increase in BUN in group 3 supports the activity of the biologically active components of the plant.Azadirachta indica and Senna siamea also have a very good antioxidant power, which would allow them to reduce the damage induced by oxidative stress [Azadirachta indica significantly increased the levels of CAT and GSH [Azadirachta indica considerably attenuates oxidative stress and inflammation [Azadirachta indica significantly increased the levels of CAT and SOD and decreased the levels of GSH [Senna siamea had a very high antioxidant power [Indeed, among the many properties of our plants, e stress , 28, 30. and GSH . Likewisammation . Gupta ent power , 37.Azadirachta indica and Senna siamea boosts the immune system of HIV-positive patients, by stimulating the production of CD4+ cells. Daily consumption of the decoction over 3 months is not toxic; on the contrary, it would reduce the liver and kidney toxicity caused by taking antiretroviral therapy (ARTs), by increasing the production of antioxidant enzymes, such as SOD and catalase.A decoction of Senna siamea only which until now has never been realized. Similarly, it is necessary to fractionate these plants to identify the metabolites responsible for these effects. Late chronic toxicity studies are also required to rule out the possibility of any delayed toxic effects.There are certain limitations to the study that should be mentioned here. For example, it would be essential that further studies be devoted to the antiretroviral activity of