Gay and bisexual men who are at risk for HIV infection should consider using antiretroviral drugs for pre-exposure prophylaxis, better known as PrEP, according to new guidelines from the World Health Organization.
The WHO recommendation is similar to U.S. Centers for Disease Control and Prevention guidelines released in May, which state that health care providers should consider advising people at "substantial risk" to use PrEP to prevent HIV infection.
"With the WHO's recommendation, two of the world's most important public health institutions have recommended that gay and bisexual men who could become infected by HIV carefully consider PrEP," said Project Inform Executive Director Dana Van Gorder. "In Project Inform's view, this would especially include men and transgender women who ever bottom without condoms."
Noting that HIV infection rates among gay and bi men remain high almost everywhere and new prevention options are urgently needed, WHO strongly recommended that men who have sex with men consider taking antiretroviral drugs as an additional method of protection along with condoms.
The Food and Drug Administration approved Gilead Sciences' Truvada combination pill for PrEP in July 2012. The two drugs in Truvada, tenofovir and emtricitabine, have been approved for HIV treatment for more than a decade and are considered safe and well tolerated. Tenofovir can cause impaired kidney function and bone loss in some people, but so far it has shown minimal side effects in PrEP studies.
The international iPrEx trial found that daily use of Truvada reduced the risk of HIV infection for gay and bisexual men and transgender women by 42 percent overall, rising to more than 90 percent among participants with blood drug levels indicating regular daily use.
Mathematical models estimate that widespread use of PrEP could reduce HIV incidence among men who have sex with men by 20-25 percent worldwide, preventing up to 1 million new infections.
"The WHO recommendation for PrEP for men who have sex with men is extremely important," iPrEx lead investigator Robert Grant from UCSF told the Bay Area Reporter. "These recommendations highlight how HIV uninfected people can play an important role in getting to zero transmissions. These medications have a proven record of safety and effectiveness for treatment and prevention."
The WHO PrEP recommendation was included in new guidelines for HIV prevention, diagnosis, treatment, and care for key populations, released ahead of the 20th International AIDS Conference that starts Sunday in Melbourne, Australia.
"Failure to provide adequate HIV services for key groups - men who have sex with men, people in prison, people who inject drugs, sex workers, and transgender people - threatens global progress on the HIV response," WHO warned. "These people are most at risk of HIV infection yet are least likely to have access to HIV prevention, testing, and treatment services. In many countries they are left out of national HIV plans, and discriminatory laws and policies are major barriers to access."
So far, uptake of PrEP has been relatively slow. A Gilead survey showed that about half of all Truvada PrEP users in the U.S. are women. San Francisco has taken the lead, having implemented one of the country's first PrEP demonstration projects. Many local doctors are prescribing PrEP, and most insurers are covering it, but some resistance remains.
"The CDC and WHO recommendations should put to rest the harmful efforts of community members and medical providers who would deny people the right to choose PrEP in order to protect their health," said Van Gorder. "Armed with these sound and important WHO and CDC recommendations, people who want to start PrEP are in a superior position to advocate for what they believe is the right prevention intervention for them."