WHO okays non-surgical circumcision devise to slow spread of HIV

The World Health Organization (WHO) last week prequalified a non-surgical circumcision device, PrePex that could delay the spread of the HIV/Aids pandemic.

PrePex is a disposable and easy-to-use device made of rubber bands. When applied to penis, the foreskin dies from a lack of oxygen and either falls off on its own or is easily cut off. This procedure is non-surgical, bloodless and requires no injected anaesthesia. 

 

WHO based its prequalification (a process to ensure that medicines, diagnostics and medical devices meet international standards of quality, safety and efficacy) of PrePex on a range of clinical data, including trials of the device in Rwanda, Uganda and Zimbabwe and evaluation of the manufacturing facilities and processes for the device. In a statement it (WHO) issued on Friday, it is estimated that if 80 percent of adult men in 14 priority African countries (with high HIV incidence and low rates of voluntary medical male circumcision) were to undergo the procedure by 2015, 20 percent of all new infections in men and women would be averted by 2025 in those countries.

Angelo Kaggwa, the program coordinator of the AIDS Vaccine Advocacy Coalition (AVAC) said that international donors have indicated a willingness to fund pilot studies and introduce PrePex for VMMC programs. However, African governments need to evaluate whether PrePex is a good additional option and develop policies and budgets to match.

 “This initial prequalification of PrePex is only for men 18 and older. One of the key next steps for PrePex must be to gather data on safety and effectiveness among younger men and adolescents,” he said adding that many men seeking surgical procedures are under 18 and there is need to provide them with a range of options.

Prepex was developed by Circ MedTech; an Israeli company founded in 2009 and was validated for the safety and efficacy by the Government of Rwanda and findings published in the Journal of Acquired Immune Deficiency Syndromes (JAIDS).

According to the WHO statement, the impact of PrePex and other non-surgical devices that could also be prequalified will depend on factors including the cost of the devices, quality and scope of data available to guide decisions about product introduction.

The cost of the device is reported to be $20 (Shs 52,000) which may be a barrier for widespread use. 

PrePex was first approved by the U.S. Food and Drug Administration in 2012 and certified by the European Union.

Landmark clinical trials in three Uganda, South Africa and Kenya in 2007 showed that voluntary medical male circumcision reduced HIV-negative men’s risk of HIV infection by at least 60 percent.

Dr Joshua Musinguzi, the acting Programme Manager of the AIDS Control Program said circumcision reduces the surface area for the virus to thrive.

“It is estimated that the removed foreskin reduces the surface area by about the size of the forehead and removes the Langerhans cells which act as receptors for the virus,” he said. The cells are found in the foreskin.

After circumcision, the area develops a scar and is therefore hard. This reduces the permeability capacity of virus.

Uganda’s position;

In its National HIV Prevention Strategy for 2011-15 and its HIV Prevention Action Plan, Uganda’s government has identified safe male circumcision as one of five priority evidence-based biomedical interventions and targets 4.2 million eligible men undergoing the procedure by 2015.

However, of the 1.2 million men that were targeted last year, only 380,000 were circumcised according to the ministry of health records and the 2011 Uganda Demographic Health Survey indicates that 24% of men in Uganda are circumcised.

To scale up efforts, the U.S. through the President’s Emergency Plan for AIDS Relief (PEPFAR) is offering support through funding, going from over $1.6 (Shs 4b) million in 2009 to over $31 million (Shs 80b) in 2012. It has supported more than 450,000 circumcisions in Uganda since April 2010.

 Currently, the Ministry of Health is spearheading a campaign dubbed, “Stand Proud, Get Circumcised” to educate the public and promote the uptake of safe male circumcision among men 15 years and older.