The virological durability of first-line ART among HIV-positive adult patients in resource limited settings without virological monitoring: a retrospective analysis of DART trial data

摘要

Background Few low-income countries have virological monitoring widely available. We estimated the virological durability of first-line antiretroviral therapy (ART) after five years of follow-up among adult Ugandan and Zimbabwean patients in the DART study, in which virological assays were conducted retrospectively. Methods DART compared clinically driven monitoring with/without routine CD4 measurement. Annual plasma viral load was measured on 1,762 patients. Analytical weights were calculated based on the inverse probability of sampling. Time to virological failure, defined as the first viral load measurement ≥200 copies/mL after 48?weeks of ART, was analysed using Kaplan-Meier plots and Cox regression models. Results Overall, 65% of DART trial patients were female. Patients initiated first-line ART at a median (interquartile range; IQR) age of 37 (32–42) and with a median CD4 cell count of 86 (32–140). After 240?weeks of ART, patients initiating dual-class nucleoside reverse-transcriptase inhibitor (NRTI) -non-nucleoside reverse-transcriptase (NNRTI) regimens containing nevirapine?+?zidovudine?+?lamivudine had a lower incidence of virological failure than patients on triple-NRTI regimens containing tenofovir?+?zidovudine?+?lamivudine (21% vs 40%; hazard ratio (HR) =0.48, 95% CI:0.38–0.62; p 3, 95% CI: 0.54–0.75; p Conclusions The long-term durability of virological suppression on dual-class NRTI-NNRTI first-line ART without virological monitoring is remarkable and is enabled by high-quality clinical management and a consistent drug supply. To achieve higher rates of virological suppression viral-load-informed differentiated care may be required. Trial Registration Prospectively registered on 18/10/2000 as ISRCTN13968779 .