WHO okays medical circumcision device, and “PEPFAR is ready”

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Source: World Health Organization

Source: World Health Organization

An okay from the World Health Organization today for  a medical circumcision device as an alternative to conventional surgery “may change the landscape” of scaling up a proven HIV intervention, the Office of the Global AIDS Coordinator announced today, saying PEPFAR will provide immediate support to help countries evaluate the device for their settings.

PrePex™, a three-part device that includes size-adjusted rubber bands  and a ring to compress blood flow to the foreskin, is the first nonsurgical medical circumcision device to receive an approval from WHO, and is considered a potentially more appealing alternative to surgical circumcision, for men seeking to reduce their chances of becoming infected with HIV through vaginal intercourse. Medical circumcision has been shown to reduce men’s risk of HIV acquisition through vaginal intercourse by 60 percent or more. It has been an intervention recommended by WHO since 2007. With widespread adoption of medical circumcision, Global AIDS Coordinator Ambassador Eric Goosby has said, “We expect a drop in [HIV] prevalence. It will look like a vaccine has entered the community.” PEPFAR has supported more than 2 million surgical circumcisions across Africa. Studies using modeling have produced estimates that an 80 percent increase in medical circumcision in countries where HIV is high and rates of circumcision are currently low, would lead to as much a a 67 percent drop in HIV prevalence in those regions.

Unlike surgical circumcision, using PrePex™ for circumcision does not require injected anesthetic, sutures, or a sterile environment, and takes a total of five minutes across two visits, according to the company website, where a video of the procedures involved is available. While a study published in January concluded that the device is “unlikely to result in significant cost-savings” in comparison to the most widely used surgical technique, OGAC’s statement says the use of the device may speed medical circumcision scale-up, “potentially simplifying the procedure and improving men’s experiences.”

Prepex™ received prequalification from WHO, a status that does not replace individual countries’ regulatory authorities, but indicates that the device complies with international standards. WHO considered studies of the device’s safety and efficacy that were carried out in Rwanda, Zimbabwe and Uganda, in the prequalifying the device.

The WHO prequalification of Prepex™ put the device on a list of one, but a news release from OGAC says "PEPFAR is optimistic" that at least one more device will be prequalified for use on adult men soon.

The WHO prequalification of Prepex™ put the device on a list of one, but a news release from OGAC says “PEPFAR is optimistic” that at least one more device will be prequalified for use on adult men soon.

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