Advocates, policy experts respond to FDA approval of Truvada for HIV prevention

Jul 18 2012

Though the FDA's Monday approval of the antiretroviral drug Truvada for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV infection among people at risk of contracting the virus "was hailed by many as an important step in the fight against AIDS, concerns that people will incorrectly use the drug -- potentially spurring drug resistance -- led others to blast the agency for not laying down tougher rules," the Wall Street Journal's "Health Blog" writes. "Instead of requiring that people prove they are HIV-negative before getting a prescription filled, the FDA slapped a boxed warning on the drug, saying it must only be used by people who have a confirmed HIV-negative test prior to getting a prescription, and then get tested at least every three months while they are using it," the blog notes (Marcus, 7/16).

Michael Weinstein, president of the AIDS Healthcare Foundation, "denounced the approval" and expressed concern over the potential for the development of drug-resistant HIV strains among people who are unknowingly HIV-positive, as well as the potential loss of protection among HIV-negative people who do not take the drug daily as prescribed, the Washington Post reports. The newspaper adds that Jen Kates, vice president and director of global health and HIV policy at the Kaiser Family Foundation, said, "Drug adherence is really key here" (Vastag, 7/16). "One of the conditions of the FDA approval is that Gilead has to collect viral strains from people who become infected with HIV while taking Truvada and test them for any signs of drug resistance," the Wall Street Journal writes (7/16). Cost and access in the developing world also are concerns, Bloomberg reports, noting that "Gilead sells Truvada in the least-developed countries at no profit and has given the rights to sell the drug to Indian generic makers to help lower the price in 112 countries, said Cara Miller," a Gilead spokesperson (Pettypiece/Jordan, 7/16).