(CBS/AP) Federal drug regulators on Tuesday affirmed landmark study results showing that a popular HIV-fighting pill can also help healthy people avoid contracting the virus that causes AIDS in the first place. While the pill appears safe and effective for prevention, scientists stressed that it only works when taken on a daily basis.
The Food and Drug Administration will hold a meeting Thursday to discuss whether Truvada should be approved for people who are at risks of contracting HIV through sexual intercourse. The agency’s positive review posted Tuesday suggests the daily pill will become the first drug approved to prevent HIV infection in high-risk patients.
FDA reviewers conclude that taking Truvada pre-emptively could spare patients
“infection with a serious and life-threatening illness that requires lifelong treatment.”
Despite the positive results, reviewers said that patients must be diligent about taking the pill every day. Adherence to the medication was less than perfect in clinical trials, and reviewers said that patients in the real world may forget to take their medication even more than those in clinical studies.
More than one million people in the U.S. are living with HIV, according to AIDS.gov. About 20 percent of them are unaware that they have the disease. Men who have sex with men in the African American community are the most affected by the disease. More than 619,000 people with AIDS have died in the U.S. since the epidemic began in June 1981.
HIV attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off foreign infections.
First announced in 2010, Truvada’s preventive ability was hailed as a breakthrough in the 30-year campaign against the AIDS epidemic. A three-year study found that daily doses cut the risk of infection inhealthy gay and bisexual men by 44 percent, when accompanied by condoms and counseling. Another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was HIV infected and the other was not.
The FDA’s panel of advisers will take separate votes on whether Truvada should be approved for: