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Clinical Presentation, Treatment Response and Virology Outcomes of Women who Seroconverted in the Dapivirine Vaginal Ring Trials - The Ring Study and DREAM.

BACKGROUND
Participants who HIV seroconverted in The Ring Study, a Phase III trial of Dapivirine Vaginal Ring (DVR), or in the open-label extension trial DREAM, were offered enrollment in an observational cohort study (IPM 007) to assess clinical presentation and response to antiretroviral treatment (ART).


METHODS
Participants' HIV infection was managed at local treatment clinics according to national treatment guidelines. IPM 007 study visits occurred 3 and 6 months after enrollment, and every 6 months thereafter. Assessments included plasma HIV-1 RNA, CD4+ T-cell counts, and recording of HIV/AIDS-associated events and ARV use. Post-hoc virology analyses were performed for participants identified with virologic failure.


RESULTS
One-hundred-and-fifty-one of 179 eligible participants (84.4%) enrolled into IPM 007; 103 had previously received the DVR in the Ring or DREAM studies; 48 had received placebo in The Ring Study. HIV-1 RNA and CD4+ T-cell counts after 12 months' follow-up were similar for participants who used the DVR in The Ring Study and DREAM, compared to those who received placebo. Of the 78 participants with a study visit approximately 6 months after ART initiation, 59 (75.6%) had HIV-1 RNA <40 copies/mL (The Ring Study: placebo: 13/23; 56.5%; DVR: 32/39; 82.1%; DREAM [DVR]: 14/16; 87.5%). Post-hoc virology analysis indicated that genotypic patterns observed at virologic failure were as expected of an NNRTI-based regimen.


CONCLUSIONS
Seroconversion during DVR use did not negatively affect clinical presentation or treatment outcome. Mutation patterns at virologic failure were in line with individuals failing an NNRTI-based regimen.