Suppression of HIV in the first 12 months of antiretroviral therapy: a comparative analysis of dolutegravir- and efavirenz-based regimens.

OBJECTIVE: To compare viral suppression in treatment-naïve adults starting antiretroviral therapy with dolutegravir (50mg)- and efavirenz (600mg)-based regimens. METHODS: We analyzed secondary data from Brazilian health information systems of people living with human immunodeficiency virus who started antiretroviral therapy between 2015 and 2017 in Minas Gerais, Brazil. The outcome was viral suppression, defined as the achievement of the first viral load <50 copies/mL within 12 months after initiating antiretroviral therapy. This outcome was also compared with viral load <1,000 copies/mL and analyzed in two scenarios: intention-to-treat versus per-protocol. Time to viral suppression and adjusted odds ratio accompanied by 95% confidence intervals were estimated. RESULTS: Of the 2,599 participants enrolled, 77.5% were men, and the median age was 34 years. In the intention-to-treat analysis, viral suppression was 58.1% for efavirenz and 76.7% for dolutegravir. People living with HIV on dolutegravir-based regimen were more likely to achieve viral suppression (aOR: 2.44; 95%CI: 2.01-2.95) and had a shorter median time to viral suppression (p<0.0001). Antiretroviral therapy initiation within <120 days, baseline CD4⁺T-cells ≥200 cells/mm3, and viral load <100,000 copies/mL had higher odds of viral suppression. According to the per-protocol analysis, viral suppression ≥90% was observed by considering viral load <1,000 copies/mL. CONCLUSION: Our study demonstrated that viral suppression improved after introducing dolutegravir, although the proportion of patients with viral load <50 copies/mL was lower than expected. Improved access to routine viral load examinations and continuous surveillance of the effectiveness of antiretroviral therapy should be considered.

Suppression of HIV in the first 12 months of antiretroviral therapy: a comparative analysis of dolutegravir- and efavirenz-based regimens

ABSTRACT Objective To compare viral suppression in treatment-naïve adults starting antiretroviral therapy with dolutegravir (50mg)- and efavirenz (600mg)-based regimens. Methods We analyzed secondary data from Brazilian health information systems of people living with human immunodeficiency virus who started antiretroviral therapy between 2015 and 2017 in Minas Gerais, Brazil. The outcome was viral suppression, defined as the achievement of the first viral load <50 copies/mL within 12 months after initiating antiretroviral therapy. This outcome was also compared with viral load <1,000 copies/mL and analyzed in two scenarios: intention-to-treat versus per-protocol. Time to viral suppression and adjusted odds ratio accompanied by 95% confidence intervals were estimated. Results Of the 2,599 participants enrolled, 77.5% were men, and the median age was 34 years. In the intention-to-treat analysis, viral suppression was 58.1% for efavirenz and 76.7% for dolutegravir. People living with HIV on dolutegravir-based regimen were more likely to achieve viral suppression (aOR: 2.44; 95%CI: 2.01-2.95) and had a shorter median time to viral suppression (p<0.0001). Antiretroviral therapy initiation within <120 days, baseline CD4⁺T-cells ≥200 cells/mm3, and viral load <100,000 copies/mL had higher odds of viral suppression. According to the per-protocol analysis, viral suppression ≥90% was observed by considering viral load <1,000 copies/mL. Conclusion Our study demonstrated that viral suppression improved after introducing dolutegravir, although the proportion of patients with viral load <50 copies/mL was lower than expected. Improved access to routine viral load examinations and continuous surveillance of the effectiveness of antiretroviral therapy should be considered.

Metabolic comorbidities and systemic arterial hypertension: the challenge faced by HIV patients on long-term use of antiretroviral therapy.

OBJECTIVE: Our objective was to estimate the frequency of comorbidities and assess its relationship with exposure factors after long-term ART use. METHODS: A cross-sectional study with PLHIV (≥18 years-old), who initiated ART between 2001 and 2005 and attended an HIV/AIDS public referral center (Belo Horizonte/Brazil), was performed. Demographic, clinical, therapeutic, and lifestyle data were obtained through interviews, medical charts, public database, routine laboratory examinations, and bone densitometry. The outcome was the number of comorbidities: hyperglycemia, dyslipidemia, systemic arterial hypertension (SAH), and low bone mineral density (BMD). Absolute/relative frequencies were calculated. Factors associated with the outcome were assessed by quasi-Poisson regression. RESULTS: Of the 98 participants, 53% were male and 79% and over 43 years-old. Moderate physical activity was observed in 82%, overweight/obesity in 50%, and 58% used ART based on two nucleoside reverse transcriptase inhibitors (NRTIs) plus one non-nucleoside reverse transcriptase inhibitor (NNRTI). After a mean of 15.6 years of ART exposure, 207 comorbidities were identified and 93% participants presented at least one comorbidity (mean = 2.1/participant). The most frequent overlapping constituted two co-occurrences: dyslipidemia + hyperglycemia or dyslipidemia + SAH, n = 36 for each co-occurrence. The quasi-Poisson regression showed an increase of 3% in the number of comorbidities per year of age (OR = 1.03; 95%CI = 1.02-1.04) and 84% among PLHIV on moderate physical activity (ref = heavy physical-activity) (OR = 1.84; 95%CI = 1.08-3.13). CONCLUSIONS: Our study shows that the aging slightly contributed to comorbidities. However, the practice of physical-activities is crucial to prevent chronic-diseases. Treatment and preventive measures should be encouraged to diminish the burden of disease and improve quality of life among PLHIV.

Monitoring HIV infection in Minas Gerais state: 15-year assessment of adults living with HIV initiating Antiretroviral Therapy.

INTRODUCTION: The first Brazilian HIV treatment recommendation was put forward in 1996, resulting in 12 subsequent guidelines. Several changes were made regarding "when" and "how" to begin treatment. The latest guideline recommends immediate initiation of antiretroviral therapy (ART). This study aimed to describe the evolution of HIV treatment among people living with HIV (PLHIV) who initiated ART between 2004 and 2018 based on the national guideline recommendations concerning T-CD4+ and VL measurements. METHODS: A cross-sectional analysis of data of PLHIV aged >18 years, in Minas Gerais who received ART between 2004 and 2018 was conducted. Clinical, therapeutic, and demographic information were obtained from national healthcare databases. The study was divided into four periods: 2004-2007, 2008-2012, 2013-2016, and 2017-2018. Descriptive analyses were performed. RESULTS: A total of 60,618 PLHIV initiated ART (67% male and 48% aged 25-39 years), 36% of whom had CD4 counts at ART initiation and 51% documented VL after ART initiation. The median CD4 count ranged from 288 to 373 cells/µL. The median time to ART initiation decreased from 604 to 28 days and was lower among males (p <0.01). The median time from ART initiation to the first VL result decreased from 101 to 62 days over the study period, while the median VL after ART initiation ranged from 2.3 to 1.7 log10 copies/ml. CONCLUSIONS: Although our results demonstrated that most recommendations were followed, there seemed to be little impact on CD4 counts and VL testing. This may result in an inadequate evaluation of ART effectiveness.

Osteopenia and osteoporosis among treatment-experienced people living with HIV

Abstract Introduction Life expectancy of people living with human immunodeficiency (PLHIV) has increased mainly due to the accessibility and effectiveness of antiretroviral therapy (ART). However, adverse effects from long-term use of antiretrovirals, and the physiological changes associated with aging, may compromise the quality of life of PLHIV, in addition to causing new demands on the healthcare system. Objectives Estimate the frequency of osteoporosis and osteopenia in patients on prolonged ART and to verify their associated factors. Methods A cross-sectional study was conducted in Belo Horizonte, Minas Gerais, Brazil, from August 2017 to June 2018, in a sample of PLHIV (age≥18 years) who started ART between 2001 and 2005. Data were collected through face-to-face interviews, physical evaluation, laboratory tests, and Dual-Energy X-Ray Absorptiometry Screening (DEXA). The outcome of interest was presence of bone alteration, defined as presence of osteopenia or osteoporosis in DEXA. The association between the explanatory variables and the event was assessed through odds ratio (OR) estimate, with 95% confidence interval (CI). Multiple logistic regression was performed to evaluate factors independently associated with bone alteration. Results Among 92 participants, 47.8% presented bone alteration (19.6% osteoporosis and 28.2% osteopenia). The variables that remained in the final logistic regression model were age ≥ 50 years (OR: 12.53; 95% CI: 4.37-35.90) and current alcohol use (OR: 2.63; 95% CI: 0.94-7.37). Conclusions This study showed a high frequency of bone changes, especially in PLHIV older than 50 years. This information is useful to stimulate the screening and timely intervention of this comorbidity of PLHIV on prolonged use of ART in order to prevent or minimize complications and new demands on the healthcare system.

Osteopenia and osteoporosis among treatment-experienced people living with HIV.

INTRODUCTION: Life expectancy of people living with human immunodeficiency (PLHIV) has increased mainly due to the accessibility and effectiveness of antiretroviral therapy (ART). However, adverse effects from long-term use of antiretrovirals, and the physiological changes associated with aging, may compromise the quality of life of PLHIV, in addition to causing new demands on the healthcare system. OBJECTIVES: Estimate the frequency of osteoporosis and osteopenia in patients on prolonged ART and to verify their associated factors. METHODS: A cross-sectional study was conducted in Belo Horizonte, Minas Gerais, Brazil, from August 2017 to June 2018, in a sample of PLHIV (age ≥ 18 years) who started ART between 2001 and 2005. Data were collected through face-to-face interviews, physical evaluation, laboratory tests, and Dual-Energy X-Ray Absorptiometry Screening (DEXA). The outcome of interest was presence of bone alteration, defined as presence of osteopenia or osteoporosis in DEXA. The association between the explanatory variables and the event was assessed through odds ratio (OR) estimate, with 95% confidence interval (CI). Multiple logistic regression was performed to evaluate factors independently associated with bone alteration. RESULTS: Among 92 participants, 47.8% presented bone alteration (19.6% osteoporosis and 28.2% osteopenia). The variables that remained in the final logistic regression model were age ≥ 50 years (OR: 12.53; 95% CI: 4.37-35.90) and current alcohol use (OR: 2.63; 95% CI: 0.94-7.37). CONCLUSIONS: This study showed a high frequency of bone changes, especially in PLHIV older than 50 years. This information is useful to stimulate the screening and timely intervention of this comorbidity of PLHIV on prolonged use of ART in order to prevent or minimize complications and new demands on the healthcare system.

Monitoring HIV infection in Minas Gerais state: 15-year assessment of adults living with HIV initiating Antiretroviral Therapy

Abstract INTRODUCTION The first Brazilian HIV treatment recommendation was put forward in 1996, resulting in 12 subsequent guidelines. Several changes were made regarding "when" and "how" to begin treatment. The latest guideline recommends immediate initiation of antiretroviral therapy (ART). This study aimed to describe the evolution of HIV treatment among people living with HIV (PLHIV) who initiated ART between 2004 and 2018 based on the national guideline recommendations concerning T-CD4+ and VL measurements. METHODS A cross-sectional analysis of data of PLHIV aged >18 years, in Minas Gerais who received ART between 2004 and 2018 was conducted. Clinical, therapeutic, and demographic information were obtained from national healthcare databases. The study was divided into four periods: 2004-2007, 2008-2012, 2013-2016, and 2017-2018. Descriptive analyses were performed. RESULTS A total of 60,618 PLHIV initiated ART (67% male and 48% aged 25-39 years), 36% of whom had CD4 counts at ART initiation and 51% documented VL after ART initiation. The median CD4 count ranged from 288 to 373 cells/µL. The median time to ART initiation decreased from 604 to 28 days and was lower among males (p <0.01). The median time from ART initiation to the first VL result decreased from 101 to 62 days over the study period, while the median VL after ART initiation ranged from 2.3 to 1.7 log10 copies/ml. CONCLUSIONS Although our results demonstrated that most recommendations were followed, there seemed to be little impact on CD4 counts and VL testing. This may result in an inadequate evaluation of ART effectiveness.

HIV pre-exposure prophylaxis (PrEP) awareness and acceptability among trans women: a review.

Transgender (trans) women are disproportionally burdened by the HIV epidemic due to complex structural, psychosocial and biological factors. HIV pre-exposure prophylaxis (PrEP) is a biomedical prevention approach for people at substantial risk of acquiring HIV. This literature review assessed awareness, willingness to use, and barriers and facilitators for PrEP acceptability among trans women. A search was conducted through five databases and included studies with primary data and disaggregate results for trans women. Of 255 retrieved citations, 17 met the inclusion criteria and were included. Low to moderate knowledge about PrEP was observed among studies. However, willingness to use PrEP was predominantly high. Frequent barriers to PrEP acceptability included concerns about side effects, cost, hormone therapy, adherence, PrEP-related stigma and interaction with healthcare workers. Facilitators included perceived reduction of HIV risk, fear of HIV/AIDS and reduced dependence on partners. Findings suggest elevated interest in PrEP and highlight important barriers and facilitators that should be specifically addressed to optimize PrEP uptake and use among this highly vulnerable population.

Effectiveness of second-line antiretroviral therapy: the impact of drug switches.

Including antiretroviral drug switches as a measure of ART failure could be more suitable than conventional measures to evaluate health outcomes in "real-world" settings. This is part of a historical cohort of HIV-infected adults who initiated ART from 2001-2005, and were followed up for a maximum of five years in three HIV/AIDS centers in Belo Horizonte, Brazil. Follow-up information included data from 2001-2010. All patients switched from first-line ART were included. Second-line ART effectiveness was measured as the time-to-ART failure. Failure was defined simulating two scenarios: (1) Clinical, immunological and virological failure (scenario 1); and scenario 1 plus ART switches (scenario 2). Descriptive analysis, Kaplan-Meier curves, log-rank test, and Cox proportional hazards model were performed. We identified 119 eligible patients; most had protease inhibitor (PI)-based regimens prescribed as second-line. The incidence of failure was different for the two scenarios (29.4% vs. 54.6% for scenario 1 and 2, respectively; p < 0.001). The main identifiers of failure were increase in viral load (31.1%) for scenario 1 and ART switches (42.8%) for scenario 2. Median duration on second-line ART was 36.8 vs. 19.8 months for scenario 1 and 2, respectively. In the Cox analysis of scenario 2, increased risk was found for patients given PI-based second-line regimens (HR = 2.26; 95% CI: 1.09-3.17). There is a high incidence of ART failure associated with PI-based regimens when ART switches are considered as an indicator of failure. This demonstrates the impact of ART switches in representing lack of ART effectiveness.

Adverse reactions to antiretroviral therapy: a prevalent concern / Las reacciones adversas al tratamiento antirretroviral: una preocupación frecuente / Reações adversas à terapia antirretroviral: uma preocupação frequente

The risk–benefit ratio of antiretroviral therapy (ART) is usually considered favorable due to the urgent need to control the HIV/AIDS epidemic. Current studies have shown that combined ART (two or more drugs, from two different classes) is the most effective, with benefits that go beyond clinical management of the disease playing a crucial role in preventing HIV transmission. Therefore, early identification of HIV infection followed by immediate initiation of ART has been encouraged worldwide. However, the success of this strategy has been threatened by poor engagement of patients in HIV care, which may be related to drug harms. In addition, ART is required for the life course, creating the potential for adverse drug reactions (e.g., lipodystrophies). Therefore, adverse drug reactions are a prevalent concern among people living with HIV/AIDS, even in the current era of early initiation of ART (“early ART”), with most drugs considered much safer than those used in previous eras. Accurate diagnosis, recording, and reporting, followed up with proper management and prevention, and intensive surveillance, of new and known adverse reactions to ART, should be strongly encouraged as part of the care continuum.

La relación entre los riesgos y beneficios del tratamiento antirretroviral (TAR) generalmente se considera favorable debido a la urgente necesidad de controlar la epidemia de VIH/SIDA. Los estudios actuales han revelado que la politerapia antirretrovírica (dos o más medicamentos de dos clases diferentes) es la más eficaz porque no solo trata la enfermedad, sino que tiene una función crucial como método preventivo de la transmisión del VIH. Por consiguiente, en todo el mundo se ha promovido el diagnóstico temprano de la infección por el VIH seguido del inicio inmediato del TAR. Sin embargo, la efectividad de esta estrategia ha sido comprometida por la baja retención de pacientes en los servicios de salud, que puede estar asociada a seguridad en el uso de los medicamentos. Además, dado que estos pacientes deben recibir TAR durante toda la vida, aumenta la probabilidad de que presenten reacciones adversas a los medicamentos (por ejemplo, lipodistrofias). De esta forma, las reacciones adversas a los antirretrovirales se tornaron una constante preocupación, incluso en la era actual de inicio precoz de la TAR, en que los medicamentos son considerados más seguros que aquellos utilizados en el pasado. El diagnóstico preciso, registro y notificación de las reacciones adversas, seguidos de manejo y prevención adecuados, y vigilancia intensiva para detectar reacciones adversas (nuevas y conocidas) deben ser fuertemente recomendadas como parte de la cascada del cuidado continuado.

A relação risco-benefício da terapia antirretroviral (TARV) é considerada favorável devido à urgente necessidade de controlar a epidemia de HIV/ aids. Estudos recentes demonstram que a TARV combinada (dois ou mais medicamentos de duas classes distintas) é altamente efetiva, apresentando benefícios que ultrapassam o objetivo do manejo clínico da doença, pois contribui de forma significativa para a prevenção da transmissão do HIV. Recomenda-se, portanto, o diagnóstico precoce da infecção pelo HIV e o início imediato da TARV em todo o mundo. Todavia, a efetividade dessa estratégia tem sido comprometida pela baixa retenção de pacientes nos serviços de saúde, que pode estar associada à segurança no uso dos medicamentos. Além disso, o uso da TARV se faz necessário por toda a vida, o que possibilita a ocorrência de reações adversas (como lipodistrofias). Dessa forma, as reações adversas aos antirretrovirais se tornaram uma constante preocupação, mesmo na era atual de início precoce da TARV, em que os medicamentos são considerados mais seguros do que aqueles utilizados no passado. O diagnóstico preciso, o registro e a notificação das reações adversas, acompanhados de tratamento e prevenção adequados, além de intensiva vigilância para detecção de reações adversas (novas e conhecidas) devem ser fortemente recomendadas como parte da cascata do cuidado contínuo.

High incidence of hypertriglyceridemia in a Brazilian cohort of people living with HIV/AIDS undergoing antiretroviral treatment in Belo Horizonte, 2001-2010.

INTRODUCTION:: Hypertriglyceridemia incidence should be estimated in HIV-infected patients after antiretroviral therapy (ART) initiation. METHODS:: We retrospectively analyzed clinical data of HIV-infected adults at 3 public referral centers. Cumulative and person-time incidences were estimated for patients without hypertriglyceridemia. Survival time and hazard ratio (HR) were estimated by Kaplan-Meier analysis and Cox proportional regression, respectively. RESULTS:: Cumulative and person-time incidences were 40.4% and 1.4 cases/100 person-months, respectively. The median period for hypertriglyceridemia occurrence was 47 months. Men and patients with switched ART regimens had increased hypertriglyceridemia risk (HR=3.05 and 3.34, respectively). CONCLUSIONS:: Hypertriglyceridemia incidence is high in HIV-infected patients undergoing ART.

High incidence of hypertriglyceridemia in a Brazilian cohort of people living with HIV/AIDS undergoing antiretroviral treatment in Belo Horizonte, 2001-2010

Abstract INTRODUCTION: Hypertriglyceridemia incidence should be estimated in HIV-infected patients after antiretroviral therapy (ART) initiation. METHODS: We retrospectively analyzed clinical data of HIV-infected adults at 3 public referral centers. Cumulative and person-time incidences were estimated for patients without hypertriglyceridemia. Survival time and hazard ratio (HR) were estimated by Kaplan-Meier analysis and Cox proportional regression, respectively. RESULTS: Cumulative and person-time incidences were 40.4% and 1.4 cases/100 person-months, respectively. The median period for hypertriglyceridemia occurrence was 47 months. Men and patients with switched ART regimens had increased hypertriglyceridemia risk (HR=3.05 and 3.34, respectively). CONCLUSIONS: Hypertriglyceridemia incidence is high in HIV-infected patients undergoing ART.