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

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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)523-539
Number of pages17
JournalClinical Infectious Diseases
Volume69
Issue number3
DOIs
StatePublished - Jul 18 2019

Keywords

  • HIV drug resistance
  • antiretroviral therapy outcomes
  • antiretroviral treatment
  • dapivirine vaginal ring

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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