Barcelona 2013
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| Abstract #113 - Biomedical Prevention | ||||
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Session: 40.5: Biomedical Prevention (Parallel) on Tuesday @ 16.30-18.30 in Raval Chaired by Olive Shisana, Chinese Authors: Presenting Author: Dr Ariane van der Straten - RTI International, United States |
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| Additional Authors: Dr. Prashant Sharma, Dr. Manorama Bhargava, | ||||
| Aim: Microbicide vaginal rings (VRs) can offer sustained multi-drug delivery with the potential to increase product adherence, acceptability, and efficacy. This is the first trial of a multi-drug microbicide ring with dapivirine (a non-nucleoside reverse transcriptase inhibitor) and/or maraviroc (a CCR5 co-receptor antagonist). We evaluated the adherence and acceptability of this novel VR during a safety and pharmacokinetics trial at three sites in the US. | ||||
| Method / Issue: We conducted a Phase 1, double-blind, four-arm, randomized placebo-controlled trial in 48 HIV-negative sexually abstinent women of silicone vaginal rings containing 25 mg dapivirine plus 100 mg maraviroc, 25 mg dapivirine only, 100 mg maraviroc only, or placebo used continuously for 28 days. Adherence was assessed by case report forms and computer-assisted self-interviewing (CASI) at weekly follow ups; and acceptability by CASI and semi-structured face-to-face interviews at the last product use visit. Analysis was blinded and behavioral data were combined across study groups. | ||||
| Results / Comments: Overall retention was high (98%). The mean age was 29.6 (range 20-40), 81% were not married, 54% had a main partner, and 75% had > high school education. Most (94%) reported being fully adherent with use of the ring during the 28-day period (ring was never out). One participant reported a temporary removal (to inspect ring), a full expulsion (during bowel movement) and a partial expulsion on another occasion. Another participant temporarily removed the ring when considering terminating her participation due to a new job. A third participant had a temporary removal per protocol, due to an adverse event. Another two participants experienced the ring partially coming out. All but three women were very comfortable having the ring in their vagina, 44% preferred having the ring in place every day while 51% didn?t have a preference (compared to episodic use). Only eight preferred not having the ring in place during menses. While women had a range of concerns about the ring during the study, including concerns about side effects/feeling sick (40%), ring falling out (38%), or having the ring in place during menses (31%), few of these were actually experienced. If the concerns occurred, they were neither frequent nor very bothersome. At study end, women liked the ring equally (62%) or more (38%) than at study start; and 83% said they would be very/likely to use the ring daily in the future for HIV prevention. The preferred attribute of the ring was that it couldn?t be felt and one could forget about it. The ring?s size and thickness were physical attributes reportedly disliked by eight (17%) women; while 10 (21%) also mentioned some difficulties with ring insertion. | ||||
| Discussion: Healthy abstinent women found VRs to be acceptable and most were reportedly adherent with VR use. A range of potential concerns were reported, which decreased with use. While few actual problems arose addressing concerns early in counseling may enhance VR uptake in the future, and decrease unnecessary worries. Given the high adherence to and acceptability of ring use, it holds strong promise as a sustained mechanism of vaginal microbicide delivery. | ||||
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