Seroconversion with DVR use did not negatively impact treatment outcome
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Clinical progression and virologic outcomes among study participants using the dapivirine vaginal ring vs. those given a placebo ring were similar, according to a recent trial.
“[This study was performed because] it was considered prudent to follow up those participants with HIV seroconversion in the prevention trials to assess the impact, if any, of dapivirine use on clinical progression and virologic outcomes prior to and after initiation of ART for HIV infection,” John Steytler, MBChB, vice president of pharmacovigilance and clinical development at International Partnership for Microbicides South Africa, told Healio.
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As part of the IPM 007 study, participants’ HIV infection was managed at local treatment clinics according to national treatment guidelines, with assessments for the study occurring 3 and 6 months after enrollment and every 6 months thereafter.
According to the study, these assessments included plasma HIV-1 RNA, CD4+ T-cell counts, and recording of HIV/AIDS-associated events and ART use while post-hoc virology analyses were performed for participants identified with virologic failure.
In total, 151 participants were enrolled in IPM 007 — 103 had previously received the dapivirine vaginal ring (DVR) in The Ring Study or DREAM, whereas 48 had received placebo in The Ring Study.
The study showed that HIV-1 RNA and CD4+ T-cell counts after 12 months of follow-up were similar for participants who used the DVR in The Ring Study and DREAM compared with 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 less than 40 copies/mL (The Ring Study: placebo: 56.5%, DVR: 82.1%; DREAM: DVR: 87.5%).
Steytler explained that findings relating to clinical progression and virologic outcomes were similar in participants who had used the DVR or a placebo ring in either of the parent trials at the time of seroconversion.
Because of this, he said the study showed there was no impact on future ART options for women in whom dapivirine prophylaxis has failed.
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