Weight changes after first-line antiretroviral initiation in a cohort of HIV-positive patients in Southern Spain (CAPOTA study).

BACKGROUND: Obesity among persons living with HIV (PLWH) has increased and weight gain after antiretroviral therapy (ART) can lead to metabolic disorders and impact survival. Our objective was to analyze weight and metabolic changes in HIV näive patients after 48 weeks of ART. METHODS: Observational, retrospective, multicentered cohort study comprising naïve-patients who started tenofovir alafenamide/emtricitabine/elvitegravir/cobicistat (TAF/FTC/EVG/c) or abacavir/lamivudine/dolutegravir (ABC/3TC/DTG), with no change in treatment for 48 weeks. Clinical and metabolic parameters were collected at baseline and week-48. Statistical program used was SPSS 21.0.0. RESULTS: The study included 329 participants from 6 hospitals. Participants were 89% male and 10% had AIDS diagnosis. Median age was 35 (IQR 27-43) years. Median baseline CD4 count was 417 (IQR 250-569) cell/mm3 and HIV viral load 4.65 (IQR 4.21-5.18) log10 copies/ml. Baseline median weight was 70 (IQR 62-79) kg, body mass index 23.4 (IQR 21.2-26.0) kg/m2; 22.7% overweight and 6.4% obese. ART regimens: ABC/3TC/DTG (196), TAF/FTC/EVG/c (133). Baseline characteristics were similar in both ART groups. Average weight gain at week-48 was 2.9 (SD 5.5) kg (p < 0.0001) with no differences between both groups. There was an increase in obesity (6.4%-8%; p < 0.003) and overweight (22.7%-28.9%; p < 0.0001). Weight increase was associated with AIDS: OR 3.05 (95%; CI 1.009-9.22), p = 0.048; and lower baseline weight: OR 1.032 (95% CI 1.009-1.05), p = 0.006. CONCLUSIONS: After ART initiation patients gain weight regardless of the regimen they take. Weight gain is associated with AIDS and the use of TAF/FTC/EVG/c.

Lipid Changes in Virologically Suppressed HIV-Infected Patients Switching from any Antiretroviral Therapy to the Emtricitabine/Rilpivirine/Tenofovir Single Tablet: GeSida Study 8114.

We carried out a retrospective, multicenter study of a cohort of 298 asymptomatic HIV-infected patients who switched from a regimen based on 2 nucleoside reverse transcriptase inhibitors + protease inhibitor (PI)/nonnucleoside reverse transcriptase inhibitor or ritonavir-boosted PI monotherapy to emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) to analyze lipid changes. At 24 weeks, 284 (95.3%) patients were still taking the same regimen, maintaining similar CD4 counts as at baseline (651 versus 672 cells/mm(3), P = .08), and 98.9% of them with an undetectable viral load. Eight of the other 14 patients were lost to follow up and 6 (2.0%) ceased the new regimen: 3 due to adverse effects, 2 due to virologic failure, and 1 due to abandonment. The mean levels of fasting total cholesterol (TC), low-density lipoprotein cholesterol, high-density lipoprotein cholesterol (HDL-C), and triglycerides fell at 12 and 24 weeks, with no changes detected in the TC to HDL-C ratio.

Lipid changes in HIV-patients switching to the coformulated single tablet FTC/RPV/TDF (Eviplera®). Efficacy and safety analysis. GeSida Study 8114.

INTRODUCTION: Rilpivirine (RPV) has a better lipid profile than efavirenz (EFV) in naïve patients (1). Switching to RPV may be convenient for many patients, while maintaining a good immunovirological control (2). The aim of this study was to analyze lipid changes in HIV-patients at 24 weeks after switching to Eviplera® (emtricitabine/RPV/tenofovir disoproxil fumarate [FTC/RPV/TDF]). MATERIALS AND METHODS: Retrospective, multicentre study of a cohort of asymptomatic HIV-patients who switched from a regimen based on 2 nucleoside reverse transcriptase inhibitors (NRTI)+protease inhibitor (PI)/non nucleoside reverse transcriptase inhibitor (NNRTI) or ritonavir boosted PI monotherapy to Eviplera® during February-December, 2013; all had undetectable HIV viral load for ≥3 months prior to switching. Patients with previous failures on antiretroviral therapy (ART) including TDF and/or FTC/3TC, with genotype tests showing resistance to components of Eviplera®, or who had changed the third drug of the ART during the study period were excluded. Changes in lipid profile and cardiovascular risk (CVR), and efficacy and safety at 24 weeks were analyzed. RESULTS: Among 305 patients included in the study, 298 were analyzed (7 cases were excluded due to lack of data). Men 81.2%, mean age 44.5 years, 75.8% of HIV sexually transmitted. 233 (78.2%) patients switched from a regimen based on 2 NRTI+NNRTI (90.5% EFV/FTC/TDF). The most frequent reasons for switching were central nervous system (CNS) adverse events (31.0%), convenience (27.6%) and metabolic disorders (23.2%). At this time, 293 patients have reached 24 weeks: 281 (95.9%) have continued Eviplera®, 6 stopped it (3 adverse events, 2 virologic failures, 1 discontinuation) and 6 have been lost to follow up. Lipid profiles of 283 cases were available at 24 weeks and mean (mg/dL) baseline vs 24 weeks are: total cholesterol (193 vs 169; p=0.0001), HDL-c (49 vs 45; p=0.0001), LDL-c (114 vs 103; p=0.001), tryglycerides (158 vs 115; p=0.0001), total cholesterol to HDL-c ratio (4.2 vs 4.1; p=0.3). CVR decreased (8.7 vs 7.5%; p= 0.0001). CD4 counts were similar to baseline (653 vs 674 cells/µL; p=0.08), and 274 (96.8%) patients maintained viral suppression. CONCLUSIONS: At 24 weeks after switching to Eviplera®, lipid profile and CVR improved while maintaining a good immunovirological control. Most subjects switched to Eviplera® from a regimen based on NNRTI, mainly EFV/FTC/TDF. CNS adverse events, convenience and metabolic disorders were the most frequent reasons for switching.