It’s estimated that 1.2 million Americans are currently living with HIV, and despite the availability of existing prevention tools like condoms, there are approximately 50,000 new infections each year. Nearly one-quarter (23 percent) of new HIV cases occur among women, and more than half (61 percent) occur among men who have sex with men (MSM). In particular, young African American MSM bear a heavy burden of the epidemic, with new HIV cases among this group increasing by nearly 50 percent between 2006 and 2009.
But on the heels of approving the first at-home HIV test, the FDA has approved a new use for an existing drug this week that could decrease the chance for transmission of HIV in high-risk cases. Truvada, which has already been used as an antiretroviral medication, will now be able to be used in combination with safer sex practices to help prevent sexually acquired HIV. And while the FDA warns in a statement that the drug, made by Gilead Sciences, is not a substitute for safe sex, it is being shown to lessen the risk of exposure to HIV among those who may be at highest risk.
“Today’s approval marks an important milestone in our fight against HIV,” says FDA Commissioner Margaret A. Hamburg, M.D. “Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, despite the availability of prevention methods and strategies to educate, test, and care for people living with the disease. New treatments as well as prevention methods are needed to fight the HIV epidemic in this country.”
In a study of almost 2,500 HIV-negative men and transgender women who have sex with men, Truvada was effective, even in cases with inconsistent condom use with multiple partners whose HIV status was unknown. Truvada reduced the infection rate by 42 percent compared with 75 percent using a placebo.
Truvada, taken daily, is to be used for pre-exposure prophylaxis (PrEP). As a part of this action, the FDA is strengthening Truvada’s boxed warning to alert health care professionals and uninfected individuals that Truvada for PrEP must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use.
“This approval is a major milestone in our 30-year fight against AIDS,” says Robert M. Grant, M.D., MPH at University of California in San Francisco, and lead investigator of the drug’s trial. “The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world.”
But because Truvada is a powerful antiretroviral, it also has side effects, like diarrhea, nausea, abdominal pain, headache and weight loss, as well as more serious, fatal disorders in select users. It’s also not cheap. In order to take the pill daily as recommended, it would cost as much as $13,000 a year (no telling whether insurance companies will pay for it).
The biggest worry is that the virus could become resistant to the drug if it’s the only antiviral a patient is taking. If you are on it, expect to be retesting for HIV every few months. And if you skip a day? The drug becomes much less effective.
But those who could benefit from the new drug’s use are couples in which one partner is positive and the other is negative. But this assumes that the positive person isn’t already on antivirals, which can lower HIV into low levels in the blood, thus also reducing the risk for a negative partner to become infected (when used with condoms).
Groups like the Gay Men’s Health Crisis (GMHC) are already praising the drug’s approval. ”GMHC applauds the FDA decision on Truvada which will clear the way in making this new prevention tool available for adults at high risk of contracting HIV,” says Janet Weinberg, GMHC’ COO. “PrEP drug development will be added to the vast array of HIV prevention tools including condoms, HIV testing and Post-Exposure Prophylaxis (PrEP). Truvada as PrEP will clearly be one of the first iterations for Treatment as Prevention (TasP). While we do not have all the necessary information about how the public will respond and potentially utilize this medication for prevention, our clients, family members and loved ones deserve complete support to advance HIV prevention.”
What do you think: Would you be willing to take one pill a day to help prevent HIV transmission?