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Levels of adherence to antiretroviral therapy (ART) can affect the likelihood of viral suppression differentially among ART regimens. In this prospective cohort conducted in Belo Horizonte, Brazil, we included 354 individuals who initiated ART containing tenofovir disoproxil fumarate/lamivudine/efavirenz in fixed-dose combination (TDF/3TC/EFV) or tenofovir disoproxil fumarate/lamivudine associated with dolutegravir (TDF/3TC + DTG). Viral suppression (viral load <50 copies/mL) was evaluated within six months of follow-up at different adherence levels and by therapeutic regimen. Adherence was measured by the Proportion of Days Covered (PDC) and classified into low (≤84%), intermediate (85-89%) or high (≥90%). The association between viral suppression, adherence levels, and other explanatory variables was analyzed using chi-square and multivariable logistic regression. Viral suppression was achieved by 76.0% of individuals and was more frequent among those who achieved higher levels of adherence (high adherence: 79.3%, intermediate: 71.4% and low: 45.2%), those on TDF/3TC + DTG, and those who had viral load ≤100,000 copies/mL at the onset of treatment (p < 0.05). Moreover, individuals on TDF/3TC + DTG had an approximately 90% probability of achieving viral suppression at intermediate adherence levels. These results add new insights on the possibility of lower adherence levels for contemporary antiretroviral regimens currently used as first-line therapy worldwide. [ABSTRACT FROM AUTHOR]

A quantitative descriptive study based on Brazilian Active Pharmacovigilance of Dolutegravir (DTG) Project was performed to describe the adverse drug reactions (ADRs) to DTG reported and to evaluate the noncompleteness of data from DTG active pharmacovigilance in Brazil. ADRs and clinical and individual data were obtained from information from the Pharmacovigilance Questionnaire from April 2017 to August 2019. The reported ADRs were classified using the Medical Dictionary for Regulatory Activities (MedDRA). In the evaluated period, 249,066 individuals using DTG participated in the active pharmacovigilance of DTG, with 3472 (1.39%) reporting ADRs at least once. A total of 6312 ADRs were reported, of which 57.56% were persistent and 81.46% were not serious according to the individuals' reports. Most of the reported ADRs were gastrointestinal, neurological and psychiatric. ADRs related to neural tube defects and serious neuropsychiatric ADRs have been reported. Completion of more than half of the fields in the Pharmacovigilance Questionnaire was excellent. The frequency of ADR was low in relation to the number of people living with HIV (PLHIV) using DTG in Brazil, which suggests good tolerability and safety of DTG. The DTG active pharmacovigilance database in Brazil showed good data completeness. [ABSTRACT FROM AUTHOR]

Combination Antiretroviral Therapy (cART) in single-tablet regimens (STR) is a simplification strategy that can potentially improve medication adherence and clinical outcomes. We conducted a retrospective cohort study of 1206 patients using efavirenz, tenofovir and lamivudine in multiple-tablet regimen who switched to the STR containing the same active ingredients in a southeast metropolis in Brazil. We measured adherence using the proportion of days covered (PDC≥95%) and evaluated this outcome before and after the switch using paired non-parametric statistics. Additionally, we used group-based trajectory modeling to identify adherence patterns to cART for each period and evaluate the migration behavior of patients between the trajectory groups. We observed a 14% increase in the proportion of adherent patients after switching to STR and a 6.2% increase in the proportion of patients with CD4 count>500 cells/μl (p < 0.001), without changes in viral load outcomes. We identified four adherence trajectories in each period. Most patients (60%, n = 722) migrated towards a group with better adherence trajectory or remained in the trajectory group with the highest probability of adherence after the switch. Our findings suggest that the implementation of the STR had a positive impact on adherence and CD4 count. This may potentially improve virologic outcomes later on treatment. [ABSTRACT FROM AUTHOR]

A critical feature of an adherence assessment tool is its ability to predict virologic failure in people living with HIV (PLHIV). We, therefore, aimed to compare the predictive performance of commonly used adherence measures. We systematically searched MEDLINE, Embase and LILACS up to February 2018, to identify relevant observational studies comparing the effects of any two of the following adherence measurements on virologic outcomes: electronic monitoring, pill count, pharmacy refill, self-report and physician assessment. We analyzed data by pairwise meta-analyzes with a random-effects model. The proportion of virologic failures among non-adherent participants in each adherence measure was used to calculate the odds ratio (OR), with 95% Confidence Intervals (95%CI). Heterogeneity was assessed, with potential causes identified by sensitivity and subgroup analysis. We included 38 studies with individual patient data for 18,010 patients. All possible comparisons between pairs of the five adherence measures were considered and a total of nine comparison groups could be established. Meta-analysis suggested that self-report was a better predictor of virologic failure than pill count when the recall period was within one week (OR: 2.35, 95%CI: 1.07-5.18, p = 0.03). Physician assessment had higher odds of predicting virologic failure than did either self-report (OR: 2.63, 95%CI: 1.37-5.26, p < 0.01) or pharmacy refill (OR: 3.57, 95%CI: 1.69-7.14, p < 0.001). There was no difference in the predictive performance between any of the other measures that we were able to compare (p > 0.05). The combination of multiple measures did not increase the predictive value when compared to any of the measures alone. Low-cost and simple adherence measures such as self-report predict virologic failure better than or equally well as objective measures. Our results suggest that there is no need to use expensive or time-consuming adherence measures when the objective is to identify PLHIV at risk of treatment failure. [ABSTRACT FROM AUTHOR]

Health-related quality of life (HRQoL) is a multidimensional concept involving an individual's self-perception about how a disease or treatment impacts their daily life. In this study, we evaluated the HRQoL and factors associated with this outcome in 366 patients initiating combination Antiretroviral Therapy (cART) in Belo Horizonte, Brazil.We measured HRQoL using the EuroQoL-5D 3 level (EQ-5D) and the HIV instrument of the World Health Organization (WHOQOL-HIV BREF) and identified factors associated with HRQoL using multilevel linear regression. Participants had been on cART treatment a median of 65.5 days at the time the instruments were completed. The median HRQoL of patients on the single-tablet regimen containing efavirenz/ tenofovir/ lamivudine and the multi-tablet regimen containing dolutegravir and tenofovir/ lamivudine were high, with no significant difference between groups. Factors consistently associated with lower HRQoL were being single (unmarried), having a lower educational level, recent cigarette smoking, recent signs and symptoms of anxiety or depression, comorbid disease and the occurrence of adverse drug reactions. We observed high levels of HRQoL in cART-treated people and no differences between dolutegravir and efavirenz-based regimens. This study provides inputs to future economic analysis and identifies opportunities to increase the HRQoL of patients by targeting modifiable factors. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the prevalence of adverse drug reactions (ADR) and associated factors during the use of Highly Active Antiretroviral Therapy (HAART) in patients initiating treatment.Methods: This is a cross-sectional analysis of a prospective study conducted in three public referral services specialized in HIV/AIDS care in Belo Horizonte, Brazil. Self-reported ADR and explanatory variables were obtained from face-to-face interview and from Information Systems. Associated factors with ADR were evaluated by logistic regression in SPSS software v.22.Results: We included 399 patients, of which 85.5% reported at least one and 72.7% up to 5 ADRs after HAART initiation. Neurological reactions were the most frequent, with self-reported ADRs being distinct according to HAART regimen used. The global model showed higher chance of ADRs among females (OR = 3.52) and illicit drug users (OR = 2.28). Lower chance of ADRs was found for patients aged > 33 years (OR = 0.37), DTG/TDF/3TC users (OR = 0.41), and higher physical domain of quality of life (OR = 0.78). The model restricted to patients using the single-tablet regimen EFV/TDF/3TC showed lower ADRs among patients with CD4+ T lymphocyte count > 200 cells/mm3 (OR = 0.23) and higher independence domain of quality of life (OR = 0.74). The model restricted to DTG/TDF/3TC and to other regimens showed lower ADRs with higher physical domain of quality of life (OR = 0.74 and OR = 0.55, respectively).Conclusions: The prevalence of self-reported ADRs to first-line antiretroviral regimens was high and patients using DTG/TDF/3TC had a smaller number of ADRs. In addition to HAART regimen, sociodemographic, clinical, and quality of life characteristics were associated with ADRs. [ABSTRACT FROM AUTHOR]