Regulatory Focus™ > News Articles > WHO Issues Guidance on PrEP Products to Minimize HIV Transmission

WHO Issues Guidance on PrEP Products to Minimize HIV Transmission

Posted 23 July 2012 | By Alexander Gaffney, RAC 

New guidance issued by the World Health Organization (WHO) is intended to aid countries in assessing pre-exposure prophylaxis (PrEP) drugs for use in preventing the transmission of HIV in high-risk individuals.

In a statement, WHO said the guidance is based on clinical research indicating the drugs are "both safe for people to use and effective in preventing HIV." Though the drug class is far from a silver bullet, it can still reduce rates of infection by between 40% and 75%, depending on a variety of factors including regularity of use, sexual orientation and relationship status.

WHO's guidance recommends PrEP products only be used on those who are HIV-negative to "guard against the development of drug resistance," without medical conditions likely to cause severe adverse reactions, with those able to access an uninterrupted supply of medications, and along with information for consumers regarding ways to minimize the risk of transmission.

WHO, like the US Food and Drug Administration (FDA), strongly recommends the drugs be used concurrently with condoms to further minimize the risk of HIV transmission. This was noted as being particularly important given the difficult nature of adhering to the "diligent treatment regimen required" under "real life settings," explained WHO.

The recommendation is part of WHO's role as a low-barrier regulator for many third-world countries, for which it acts as a simple regulatory authority to help boost regulatory capacity. As part of its guidance, WHO said it is "encouraging countries wishing to introduce PrEP to first establish small projects to help public health workers to better understand and realize its potential benefits."

Read more:

WHO - WHO issues first guidance on use of antiretrovirals by HIV-negative people at high risk to prevent infection

WHO Guidance - Guidance on oral pre-exposure prophylaxis (PrEP) for serodiscordant couples, men and transgender women who have sex with men at high risk of HIV

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