J R Blanco1, B Alejos2, S Moreno3. 1. Department of Infectious Diseases, Hospital San Pedro-CIBIR, Logroño, La Rioja, Spain. Electronic address: jrblanco@riojasalud.es. 2. Centro Nacional de Epidemiología, Instituto de Salud Carlos III, Madrid, Spain. 3. Department of Infectious Diseases, Hospital Ramón y Cajal, Alcalá de Henares University, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS), Madrid, Spain.
Abstract
OBJECTIVES:CD4/CD8 ratio and CD4+ T-cell percentage (CD4%) predicts the risk of AIDS and non-AIDS events. Multiple T-cell marker recovery (MTMR) has been proposed as the most complete level of immune reconstitution. We quantified differences in the CD4/CD8 ratio, CD4% recovery and MTMR after starting HIV-1 treatment with dolutegravir/abacavir/lamivudine vs. efavirenz (EFV)/tenofovir (TDF)/emtricitabine (FTC). METHODS: Exploratory post hoc analysis of the SINGLE study, a randomized double-blind, clinical trial. Percentage differences and corresponding precision based on 95% confidence intervals, and p values were calculated for CD4/CD8 ratio normalization, CD4% normalization and the achievement of MTMR. Cox models taking into account competing risks were used to estimate sub-hazard ratios when comparing the times to normalization of the CD4/CD8 ratio and the CD4% by treatment arm. RESULTS: Data from 833 participants were analysed (414 in the dolutegravir/abacavir/lamivudine arm). There were no statistically significant differences in the proportion of patients who reached a CD4/CD8 ratio ≥0.5 at weeks 48 and 96. However, at week 96, the proportion of patients with a CD4/CD8 ratio ≥1 was higher in the EFV-TDF-FTC group (difference, 11.70; 95% confidence interval, 4.49-18.91; p 0.002). The decrease from baseline in CD8+ cell count was consistently greater in the EFV-TDF-FTC arm. Analysis of CD4+ percentages showed no significant differences during the study. The proportion of patients attaining a MTMR was higher in the EFV-TDF-FTC group, although the difference was only statistically significant at week 96 (p 0.001). CONCLUSIONS: EFV-TDF-FTC showed significantly greater increases in CD4/CD8 ratio ≥1.0 or MTMR beyond treatment week 96. Additional studies are necessary to better understand the impact of these findings.
RCT Entities:
OBJECTIVES:CD4/CD8 ratio and CD4+ T-cell percentage (CD4%) predicts the risk of AIDS and non-AIDS events. Multiple T-cell marker recovery (MTMR) has been proposed as the most complete level of immune reconstitution. We quantified differences in the CD4/CD8 ratio, CD4% recovery and MTMR after starting HIV-1 treatment with dolutegravir/abacavir/lamivudine vs. efavirenz (EFV)/tenofovir (TDF)/emtricitabine (FTC). METHODS: Exploratory post hoc analysis of the SINGLE study, a randomized double-blind, clinical trial. Percentage differences and corresponding precision based on 95% confidence intervals, and p values were calculated for CD4/CD8 ratio normalization, CD4% normalization and the achievement of MTMR. Cox models taking into account competing risks were used to estimate sub-hazard ratios when comparing the times to normalization of the CD4/CD8 ratio and the CD4% by treatment arm. RESULTS: Data from 833 participants were analysed (414 in the dolutegravir/abacavir/lamivudine arm). There were no statistically significant differences in the proportion of patients who reached a CD4/CD8 ratio ≥0.5 at weeks 48 and 96. However, at week 96, the proportion of patients with a CD4/CD8 ratio ≥1 was higher in the EFV-TDF-FTC group (difference, 11.70; 95% confidence interval, 4.49-18.91; p 0.002). The decrease from baseline in CD8+ cell count was consistently greater in the EFV-TDF-FTC arm. Analysis of CD4+ percentages showed no significant differences during the study. The proportion of patients attaining a MTMR was higher in the EFV-TDF-FTC group, although the difference was only statistically significant at week 96 (p 0.001). CONCLUSIONS:EFV-TDF-FTC showed significantly greater increases in CD4/CD8 ratio ≥1.0 or MTMR beyond treatment week 96. Additional studies are necessary to better understand the impact of these findings.
Authors: Sabina Herrera; Borja M Fernandez-Felix; Peter W Hunt; Steven G Deeks; Talía Sainz; Sonya L Heath; Chad J Achenbach; Benigno Rodríguez; Christopher Mathews; Katerina Christopoulos; Kenneth Mayer; Sonia Napravnik; Santiago Moreno; Sergio Serrano-Villar Journal: J Antimicrob Chemother Date: 2020-06-01 Impact factor: 5.790
Authors: Enrique Bernal; Monica Martinez; José Antonio Campillo; Gabriel Puche; Carlos Baguena; Cristina Tomás; Amaya Jimeno; Maria Jose Alcaraz; Antonia Alcaraz; Angeles Muñoz; Eva Oliver; Alejandro de la Torre; Irene Marín; Alfredo Cano; Alfredo Minguela Journal: Open Forum Infect Dis Date: 2021-12-28 Impact factor: 4.423