scholarly journals Cabotegravir Is Not Associated With Weight Gain in Human Immunodeficiency Virus–uninfected Individuals in HPTN 077

2019 ◽  
Vol 70 (2) ◽  
pp. 319-322 ◽  
Author(s):  
Raphael J Landovitz ◽  
Sahar Z Zangeneh ◽  
Gordon Chau ◽  
Beatriz Grinsztejn ◽  
Joseph J Eron ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Weight Gain ◽  
Antiretroviral Therapy ◽  
Hiv Prevention ◽  
Integrase Inhibitor ◽  
Excess Weight ◽  
Metabolic Parameters ◽  
Excess Weight Gain ◽  
Immunodeficiency Virus ◽  
Prevention Trials

AbstractStudies in human immunodeficiency virus (HIV)–infected individuals suggest excess weight gain with integrase inhibitor–based antiretroviral therapy. The HIV Prevention Trials Network Study 077 evaluated changes in weight and fasting metabolic parameters in HIV-uninfected individuals randomized to cabotegravir or a placebo. No differences between arms were found for change in weight or fasting metabolic parameters overall or for subgroups.

scholarly journals 951. Weight Gain Associated With Antiretroviral Therapy

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S508-S508
Author(s):  
Yesha Patel ◽  
Sheila Okere ◽  
Mark Lustberg ◽  
Carlos Malvestutto
Keyword(s):  
Human Immunodeficiency Virus ◽  
Weight Gain ◽  
Antiretroviral Therapy ◽  
Weight Change ◽  
Panel Member ◽  
Male Gender ◽  
Review Panel ◽  
Factors Associated ◽  
Immunodeficiency Virus

Abstract Background Obesity is a global public health crisis with a growing prevalence in persons with human immunodeficiency virus (PWH) population. In this study, we aimed to investigate factors associated with weight gain in the PWH population. Methods This was a single-centered, retrospective cohort study of our clinic patient population from January 1, 2015 to January 1, 2019. Patients with human immunodeficiency virus (HIV) were identified from the electronic health record and a randomized sample of 300 patients who had at least two follow up appointments, were on antiretroviral therapy, and had viral loads less than 200 were evaluated. The primary outcome was weight change over follow up. Cox Proportional Hazards models were used, taking a weight gain > 3 kg as the outcome, and the time on therapy between visits as the time to event. Robust linear regression was used to model mean changes in weight, accounting for influential observations. All analysis were performed in STATA 16.0. Table 1 Results At baseline, 87% were male, 63% were white, and 65% were overweight/obese. 30% were on a protease inhibitor, 46% were on non-nucleoside reverse transcriptase inhibitor, and 37% were on an integrase inhibitor. 64% were on Tenofovir disoproxil (TDF), 8% were on Tenofovir alafenamide (TAF), and 19% were on Abacavir. Mean weight change over follow up was significantly increased at 1.31 kg (95% CI = 0.58 – 2.04 kg, p= 0.0004). TAF use and male gender were significantly associated with risk of weight gain > 3 kg in univariate analysis [respectively, OR = 2.53, 95% CI = 1.30 – 4.92, p = 0.006; OR = 2.60, 95% CI = 1.05 – 6.45, p = 0.04]. In multivariate analysis, TAF use was significantly associated with weight gain > 3 kg, while male gender was of borderline significance [respectively, OR = 2.29, 95% CI = 1.17 – 4.47, p = 0.01; OR = 2.40, 95% CI = 0.96 – 5.97, p=0.060]. Significant factors associated with weight change are noted in Table 1. Conclusion As PWH are living longer on effective ARV therapy, monitoring for weight gain is required as obesity contributes to morbidity and mortality from cardiovascular disease and metabolic diseases. Key factors for weight gain in our clinic population include male gender, baseline diagnosis of hypertension, use of TAF, bictegravir use, and rilpivirine use. Disclosures Carlos Malvestutto, MD, Gilead Sciences (Advisor or Review Panel member)ViiV Healthcare (Advisor or Review Panel member)

scholarly journals Better Virological Outcomes Among People Living With Human Immunodeficiency Virus (HIV) Initiating Early Antiretroviral Treatment (CD4 Counts ≥500 Cells/µL) in the HIV Prevention Trials Network 071 (PopART) Trial in South Africa

2019 ◽  
Vol 70 (3) ◽  
pp. 395-403 ◽  
Author(s):  
Geoffrey Fatti ◽  
Ashraf Grimwood ◽  
Jean B Nachega ◽  
Jenna A Nelson ◽  
Kelsea LaSorda ◽  
...  
Keyword(s):  
South Africa ◽  
Human Immunodeficiency Virus ◽  
Hiv Prevention ◽  
Cd4 Count ◽  
Adjusted Relative Risk ◽  
Cd4 Counts ◽  
Immunodeficiency Virus ◽  
Virological Outcomes ◽  
Prevention Trials ◽  
Cd4 Cell

Abstract Background There have been concerns about reduced adherence and human immunodeficiency virus (HIV) virological suppression (VS) among clinically well people initiating antiretroviral therapy (ART) with high pre-ART CD4 cell counts. We compared virological outcomes by pre-ART CD4 count, where universal ART initiation was provided in the HIV Prevention Trials Network 071 (PopART) trial in South Africa prior to routine national and international implementation. Methods This prospective cohort study included adults initiating ART at facilities providing universal ART since January 2014. VS (<400 copies/mL), confirmed virological failure (VF) (2 consecutive viral loads >1000 copies/mL), and viral rebound were compared between participants in strata of baseline CD4 cell count. Results The sample included 1901 participants. VS was ≥94% among participants with baseline CD4 count ≥500 cells/µL at all 6-month intervals to 30 months. The risk of an elevated viral load (≥400 copies/mL) was independently lower among participants with baseline CD4 count ≥500 cells/µL (3.3%) compared to those with CD4 count 200–499 cells/µL (9.2%) between months 18 and 30 (adjusted relative risk, 0.30 [95% confidence interval, .12–.74]; P = .010). The incidence rate of VF was 7.0, 2.0, and 0.5 per 100 person-years among participants with baseline CD4 count <200, 200–499, and ≥500 cells/µL, respectively (P < .0001). VF was independently lower among participants with baseline CD4 count ≥500 cells/µL (adjusted hazard ratio [aHR], 0.23; P = .045) and 3-fold higher among those with baseline CD4 count <200 cells/µL (aHR, 3.49; P < .0001). Conclusions Despite previous concerns, participants initiating ART with CD4 counts ≥500 cells/µL had very good virological outcomes, being better than those with CD4 counts 200–499 cells/µL. Clinical Trials Registration NCT01900977.

scholarly journals Evaluation of Phylogenetic Methods for Inferring the Direction of Human Immunodeficiency Virus (HIV) Transmission: HIV Prevention Trials Network (HPTN) 052

2020 ◽  
Author(s):  
Yinfeng Zhang ◽  
Chris Wymant ◽  
Oliver Laeyendecker ◽  
M Kathryn Grabowski ◽  
Matthew Hall ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Hiv Prevention ◽  
Hiv Transmission ◽  
Group Analysis ◽  
Whole Genome ◽  
Individual Sample ◽  
Immunodeficiency Virus ◽  
Prevention Trials ◽  
Ngs Data ◽  
Transmission Direction

Abstract Background Phylogenetic analysis can be used to assess human immunodeficiency virus (HIV) transmission in populations. We inferred the direction of HIV transmission using whole-genome HIV sequences from couples with known linked infection and known transmission direction. Methods Complete next-generation sequencing (NGS) data were obtained for 105 unique index–partner sample pairs from 32 couples enrolled in the HIV Prevention Trials Network (HPTN) 052 study (up to 2 samples/person). Index samples were obtained up to 5.5 years before partner infection; partner samples were obtained near the time of seroconversion. The bioinformatics method, phyloscanner, was used to infer transmission direction. Analyses were performed using samples from individual sample pairs, samples from all couples (1 sample/person; group analysis), and all available samples (multisample group analysis). Analysis was also performed using NGS data from defined regions of the HIV genome (gag, pol, env). Results Using whole-genome NGS data, transmission direction was inferred correctly (index to partner) for 98 of 105 (93.3%) of the individual sample pairs, 99 of 105 (94.3%) sample pairs using group analysis, and 31 of the 32 couples (96.9%) using multisample group analysis. There were no cases where the incorrect transmission direction (partner to index) was inferred. The accuracy of the method was higher with greater time between index and partner sample collection. Pol region sequences performed better than env or gag sequences for inferring transmission direction. Conclusions We demonstrate the potential of a phylogenetic method to infer the direction of HIV transmission between 2 individuals using whole-genome and pol NGS data.

scholarly journals Targeted Pregnancy and Human Immunodeficiency Virus Prevention Risk-Reduction Counseling for Young Women: Lessons Learned from Biomedical Prevention Trials

2018 ◽  
Vol 218 (11) ◽  
pp. 1759-1766 ◽  
Author(s):  
Gita Ramjee ◽  
Reshmi Dassaye ◽  
Tarylee Reddy ◽  
Handan Wand
Keyword(s):  
Risk Factors ◽  
Human Immunodeficiency Virus ◽  
Hiv Prevention ◽  
Pregnant Women ◽  
Young Women ◽  
Cox Regression ◽  
Human Immunodeficiency Virus Prevention ◽  
Immunodeficiency Virus ◽  
Prevention Trials ◽  
Hiv Acquisition

Abstract Background Women enrolled in human immunodeficiency virus (HIV) prevention efficacy trials receive counseling on prevention of HIV, sexually transmitted infections (STIs), and pregnancy during every visit. Incident pregnancy has an impact on efficacy outcomes. Incidence rates of pregnancy and HIV/STIs among women who became pregnant and associated risk factors were assessed. Methods Data from 9165 women participating in HIV prevention trials in KwaZulu-Natal, South Africa from 2002–2012 were combined. Demographic and behavioral predictors of incidence pregnancy and incidence HIV and STIs were determined using Cox regression models. Results Overall pregnancy incidence was 9.6 per 100 person-year (py) (95% confidence interval [Cl], 9.1–10.3). Human immunodeficiency virus incidence among pregnant women was 5.93 per 100 py (95% Cl, 4.73–7.44). Incidence of STIs among pregnant women for Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae, and Treponema pallidum (syphilis) were 10.87, 7.42, 3.92, and 1.43 per 100 py, respectively. In the adjusted analyses, we observed overlapping risk factors for HIV acquisition during pregnancy, ie, young age, not married/not cohabitating, and low parity. The risk of pregnancy and HIV acquisition is more than 3 times higher among young women (<20 years of age). Conclusions We identified overlapping risk factors for pregnancy and HIV incidence, suggesting an urgent need for appropriate, targeted, individual-centred counseling for women participating in HIV prevention trials.

scholarly journals Risk of Incident Diabetes Mellitus, Weight Gain, and Their Relationships With Integrase Inhibitor–Based Initial Antiretroviral Therapy Among Persons With Human Immunodeficiency Virus in the United States and Canada

2020 ◽  
Author(s):  
Peter F Rebeiro ◽  
Cathy A Jenkins ◽  
Aihua Bian ◽  
Jordan E Lake ◽  
Kassem Bourgi ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Human Immunodeficiency Virus ◽  
Weight Gain ◽  
Antiretroviral Therapy ◽  
Cox Regression ◽  
The United States ◽  
Cart Regimen ◽  
Immunodeficiency Virus ◽  
The Impact

Abstract Background Integrase strand transfer inhibitor (INSTI)–based combination antiretroviral therapy (cART) is associated with greater weight gain among persons with human immunodeficiency virus (HIV), though metabolic consequences, such as diabetes mellitus (DM), are unclear. We examined the impact of initial cART regimen and weight on incident DM in a large North American HIV cohort (NA-ACCORD). Methods cART-naive adults (≥18 years) initiating INSTI-, protease inhibitor (PI)–, or nonnucleoside reverse transcriptase inhibitor (NNRTI)–based regimens from January 2007 through December 2017 who had weight measured 12 (±6) months after treatment initiation contributed time until clinical DM, virologic failure, cART regimen switch, administrative close, death, or loss to follow-up. Multivariable Cox regression yielded adjusted hazard ratios (HRs) and 95% confidence intervals (CIs) for incident DM by cART class. Mediation analyses, with 12-month weight as mediator, similarly adjusted for all covariates. Results Among 22 884 eligible individuals, 47% started NNRTI-, 30% PI-, and 23% INSTI-based cART with median follow-up of 3.0, 2.3, and 1.6 years, respectively. Overall, 722 (3%) developed DM. Persons starting INSTIs vs NNRTIs had incident DM risk (HR, 1.17 [95% CI, .92–1.48]), similar to PI vs NNRTI initiators (HR, 1.27 [95% CI, 1.07–1.51]). This effect was most pronounced for raltegravir (HR, 1.42 [95% CI, 1.06–1.91]) vs NNRTI initiators. The INSTI–DM association was attenuated (HR, 1.03 [95% CI, .71–1.49] vs NNRTIs) when accounting for 12-month weight. Conclusions Initiating first cART regimens with INSTIs or PIs vs NNRTIs may confer greater risk of DM, likely mediated through weight gain.

scholarly journals Human Immunodeficiency Virus (HIV) Drug Resistance, Phylogenetic Analysis, and Superinfection Among Men Who Have Sex with Men and Transgender Women in Sub-Saharan Africa: HIV Prevention Trials Network (HPTN) 075 Study

2020 ◽  
Author(s):  
Mariya V Sivay ◽  
Philip J Palumbo ◽  
Yinfeng Zhang ◽  
Vanessa Cummings ◽  
Xu Guo ◽  
...  
Keyword(s):  
South Africa ◽  
Human Immunodeficiency Virus ◽  
Drug Resistance ◽  
Hiv Prevention ◽  
Transgender Women ◽  
Sub Saharan Africa ◽  
Immunodeficiency Virus ◽  
Prevention Trials ◽  
Sub Saharan ◽  
Sex With Men

Abstract Background The HIV Prevention Trials Network (HPTN) 075 study evaluated the feasibility of enrolling and retaining men who have sex with men (MSM) and transgender women (TWG) from Kenya, Malawi, and South Africa. During the study follow-up, 21 participants acquired human immunodeficiency virus (HIV) (seroconverters). We analyzed HIV subtype diversity, drug resistance, transmission dynamics, and HIV superinfection data among MSM and TGW enrolled in HPTN 075. Methods HIV genotyping and drug resistance testing were performed for participants living with HIV who had viral loads >400 copies/mL at screening (prevalent cases, n = 124) and seroconverters (n = 21). HIV pol clusters were identified using Cluster Picker. Superinfection was assessed by a longitudinal analysis of env and pol sequences generated by next-generation sequencing. Results HIV genotyping was successful for 123/124 prevalent cases and all 21 seroconverters. The major HIV subtypes were A1 (Kenya) and C (Malawi and South Africa). Major drug resistance mutations were detected in samples from 21 (14.6%) of 144 participants; the most frequent mutations were K103N and M184V/I. Phylogenetic analyses identified 11 clusters (2–6 individuals). Clusters included seroconverters only (n = 1), prevalent cases and seroconverters (n = 4), and prevalent cases only (n = 6). Superinfections were identified in 1 prevalent case and 2 seroconverters. The annual incidence of superinfection was higher among seroconverters than among prevalent cases, and was higher than the rate of primary HIV infection in the cohort. Conclusions This report provides important insights into HIV genetic diversity, drug resistance, and superinfection among MSM and TWG in sub-Saharan Africa. These findings may help to inform future HIV prevention interventions in these high-risk groups.

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