Dapirivirine Ring Not Substitute For Other HIV Prevention Methods- Dr Mgodi

Dr Nyaradzo Mgodi MBChB, MMed, Investigator of Record, HPTN-084 Zimbabwe – University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, and HPTN Executive Committee Member

THE Dapirivirine Vaginal Ring, a new effective HIV prevention tool for women, is not a substitute for existing  HIV prevention methods but rather an innovation to expand prevention options for women, Dr Nyaradzo Mgodi an HIV expert and histopathologist   has said.

By Michael Gwarisa

Speaking during a Twitter Question and Answer session that was organized by HealthTimes, Dr Mgodi said women need safe and effective biomedical HIV prevention strategies for use throughout their lives and the Dapirivirine ring presented women with such an opportunity.

Studies of other HIV prevention modalities in women are also ongoing in women and remain vitally important. These include the HVTN 703/HPTN 081 antibody mediated prevention. HPTN 084 Phase III safety and efficacy study of long-acting injectable cabotegravir compared to daily oral Truvada as PrEP, and the HVTN 705/HPX2008 (Imbokodo) vaccine trial. We look forward to the day when we will be able to offer women all of all these methods, if not more.

“The ring does not replace condoms, but should be used with condoms and all the other HIV prevention methods. Remember also that this particular ring is for HIV prevention and does not cover other STIs. Condoms are very good, but require the participation/consent of male partner. Some women need female-controlled longer-acting products like the ring,” said Dr Mgodi.

In countries where studies where conducted, the ring reduced the risk of HIV by about 30%, with no safety concerns, in two large Phase III trials: ASPIRE, conducted by MTN, and The Ring Study led by the International Partnership for Microbicides (IPM).

She added that researchers need the support of advocates, research communities, stakeholders etc to successfully implement the research and ensure women have access to SRH services.

“This one is for HIV prevention only. But already work on Multi-purpose prevention technologies has started. Rings and other drug delivery platforms that will prevent HIV, STIs and Pregnancy. Oral PrEP (pre-exposure prophylaxis) involves daily use of an ARV pill and is a method that’s approved in many countries. Oral PrEP is very effective if taken daily as directed but this can be difficult for some people or not desired. Ongoing and pending studies of the ring are vitally important.”

She added the ring was highly effective especially when adherence is high and it reduces the risk of HIV acquisition.

“Correct use – ensured through counselling messages (remember no method is a magic bullet) and ring use instructions. Once inserted correctly, rates of spontaneous expulsions are low. No woman should be left behind! Our work is to provide technical expertise to relevant authorities. My team is available to work with other organisations to ensure that every woman has access to info and HIV prevention/other SRH service.”

Responding to whether the ring interferes with sexual pleasure or intercourse, Dr Mgodi said ring was user friednly and does not affect intercourse.

“It takes two to tango — of note is that earlier studies also showed ring to be acceptable by men. It does not interfere with sexual intercourse. Am sure men would be concerned about this.

“More studies are being conducted in adolescent girls and young women, and in pregnant and breastfeeding women, that aim to provide data to support expanding ring approval for these high-risk groups sometime in the future.”

She added that in collaboration with World Health Organisation (WHO), is working with the International Partnership For Microbicides (IPM), and in-country regulators to have the ring registered in Zim and other LMICs.

“Am not sure if an application has been submitted to MCAZ as yet, but I know MCAZ has favorable review times. IPM will submit the first applications in countries where studies of the ring took place. Malawi, Uganda, South Africa, Zimbabwe, plus Kenya, Rwanda, Tanzania.

“IPM developed the ring and is seeking its regulatory approval The positive opinion by the EMA is not an approval, but it opens the door for approval in countries where women are at high risk. This is a rigorous exercise and will take time to ensure continued safety of end-user. But am hopeful that we may see the ring being available 2021/2022.  I am optimistic”

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