Clinical and Virologic Outcomes Following Initiation of Antiretroviral Therapy Among Seroconverters in the Microbicide Trials Network-020 Phase III Trial of the Dapivirine Vaginal Ring
Year: 2018
Type: article
Abstract: BACKGROUND: A vaginal ring containing dapivirine, a non-nucleoside human immunodeficiency virus (HIV)-1 reverse transcriptase inhibitor (NNRTI), was safe and effective in preventing HIV-1 infection in African women. We examined the impact of dapivirine ring use at the time of HIV-1 acquisition on subsequent HIV-1 disease progression and responses to NNRTI-containing antiretroviral therapy (ART). METHODS: HIV-1 disease progression and virologic failure following initiation of ART were assessed among women who acquired HIV-1 while participating in Microbicide Trials Network-020, a randomized, placebo-controlled trial of a monthly, dapivirine vaginal ring. RESULTS: Among the 158 participants who acquired HIV-1 (65 dapivirine, 93 placebo), no differences between dapivirine and placebo participants were observed in CD4+ cell counts or plasma HIV-1 RNA over the first year after infection (prior to ART). During follow-up, 100/158 (63%) participants initiated NNRTI-containing ART (dapivirine: 39/65; placebo: 61/93); the median time to HIV-1 RNA <200 copies/ml was approximately 90 days for both dapivirine and placebo ring recipients (log-rank P = .40). Among the 81 participants with at least 6 months of post-ART follow-up, 19 (24%) experienced virologic failure (dapivirine: 6/32, 19%; placebo: 13/39, 27%; P = .42). CONCLUSIONS: The acquisition of HIV-1 infection during dapivirine or placebo treatment in ASPIRE did not lead to differences in HIV-1 disease progression. After the initiation of NNRTI-containing ART, dapivirine and placebo participants had similar times to virologic suppression and risks of virologic failure. These results provide reassurance that NNRTI-based ART regimens are effective among women who acquired HIV-1 while receiving the dapivirine vaginal ring. CLINICAL TRIALS REGISTRATION: NCT016170096 and NCT00514098.
Source: Clinical Infectious Diseases
DOI: 10.1093/cid/ciy909
Authors: Sharon A Riddler, Jennifer E Balkus, Urvi M Parikh, John W Mellors, Carolyne Akello, Sufia Dadabhai, Felix Mhlanga, Gita Ramjee, Ashley J Mayo, Edward Livant, Amy L Heaps, Colin O’Rourke, Jared M Baeten, MTN-015 and MTN-020/ASPIRE Study Teams
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: green
Funders: University of Washington, Johns Hopkins University, University of Pittsburgh, FHI 360, South African Medical Research Council, University of Cape Town, National Institutes of Health, Center for AIDS Research, University of Washington, University of North Carolina at Chapel Hill, Medical Research Council, National Institute of Allergy and Infectious Diseases
Awards: Statistical and Data Management Center (SDMC): Microbicide Trials Network, Leadership and Operations Center (LOC): Microbicide Trials Network, South African Medical Research Council Clinical Trials Unit (MRC CTU), Laboratory Center (LC): Microbicide Trials Network, University of Washington/Fred Hutch Center for AIDS Research, Pitt-Ohio State Clinical Trials Unit, The Johns Hopkins University - Uganda Clinical Trials Unit
OpenAlex ID: W2896468431