CDC Recommends Preventative Antiviral For HIV/AIDS
By Cyndi Root
The Centers for Disease Control (CDC) issued new guidelines for the prevention of HIV/AIDS. The federal agency said that people who think they are at risk for contracting the virus, should consider taking a preventative antiviral. The CDC recommends pre-exposure prophylaxis (PrEP), a daily pill, for people who do not have the disease. Gilead Sciences’ Truvada is the only Food and Drug Administration (FDA) approved drug for the newly recommended regime, although many antiretroviral drugs could be used, and there may be an increase in applications to the FDA for HIV/AIDS prevention.
The CDC, with the new advice, acknowledges that prevention may be a key strategy in reducing the infection rates. Dr. Jonathan Mermin, director of the CDC’s national center for AIDS said in an interview with The New York Times, “On average, it takes a decade for a scientific breakthrough to be adopted. We hope we can shorten that time frame and increase people’s survival.”
Not everyone is convinced that the CDC’s move is wise. The CDC has said the preventative treatment should be used along with safe sex practices like condom use. Michael Weinstein, president of the AIDS Healthcare Foundation, argues in the NY Times article that men may use the medication as an excuse to return to unsafe sexual behaviors that the CDC, outreach groups, and physicians have been fighting against for years. He sees the new advice as a setback.
Truvada
Truvada is formulated with tenofovir and emtricitabine, nucleoside analog HIV-1 reverse transcriptase inhibitors. Its indications are for 1.) in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older and 2.) in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired
HIV-1 in adults at high risk.
The treatment is considered safe with a few side effects including weight loss and headache. Due to patent protection, generic Truvada is not available in the U.S. Last year, the FDA granted approval for generic manufacturing of Truvada for distribution outside of the U.S. Strides Arcolab Limited of Bangalore, India was approved to manufacture the drug, which is widely used for treatment in resource-poor nations.
Clinical Trials
Studies of Truvada support its efficacy in prevention in heterosexuals, homosexuals, and drug users. In the iPrEx Study, 2,499 HIV-seronegative participants took Truvada or a placebo. They were tested prior to treatment and found HIV negative. They were tested during treatment, counseled, and given condoms. People who took Truvada had a 42 percent reduction in HIV-1 acquisition compared to the placebo group.