By Meredith Cohn, The Baltimore Sun –
BALTIMORE — The federal government has for the first time approved a drug that can prevent an HIV infection, a significant development for areas and groups with high transmission rates for the virus that can develop into AIDS.
The U.S. Food and Drug Administration approved Truvada in 2004 to treat HIV, but on Monday said it can also be used to increase the odds of stopping the disease from taking hold in high-risk people such as gay men, intravenous drug users and sex workers.
“In the ’80s and early ’90s, HIV was viewed as a life-threatening disease; in some parts of the world it still is. Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time,” said Dr. Debra Birnkrant, director of the division of antiviral products at FDA, in a statement.
“But it is still better to prevent HIV than to treat a life-long infection of HIV,” she said.
The FDA stressed that the drug, manufactured by Gilead Sciences, should be used in combination with other prevention methods such as testing, counseling and condom use to be most effective.
Truvada is a combination of two antiretroviral medications that is now given with a third drug to treat the virus. It can have negative effects on bones and kidneys and can worsen hepatitis B infections, so it won’t likely be prescribed widely as a preventive measure.
Two large clinical trials showed the drug reduced the risk of HIV infection by 42 percent in gay and bisexual men and transgender women, and by 75 percent in heterosexual couples where one partner was positive. Some experts say some study participants did not take the drug as directed and the prevention rates would be higher if they had.
Government data show that about 1.2 million Americans are living with HIV, though the rate of infection has remained stable since 2004. About 50,000 more people are diagnosed every year.
Preventing more people from contracting HIV is the goal, said Dr. Joel Gallant, an infectious disease specialist and AIDS expert at Johns Hopkins Hospital.
“This is a very big step forward,” he said about the drug. “For the first time, we will be able to offer a preventive drug” to people who don’t have HIV.
It remains to be seen who gets the drug because it’s likely to be expensive, he said. The total cost isn’t known, but it could be $7,000 to $12,000 annually per person, and it would not be cost effective to hand it out to everyone.
Unlike HIV-positive people, who have access to federal funds for treatment, not everyone is likely to be covered for preventive medications. Those with insurance or Medicaid would likely have access to Truvada, but many of the most at-risk — such as African-American men in Baltimore who have sex with men — do not have insurance and do not even have a regular doctor, said Gallant, a professor in Johns Hopkins School of Medicine and the associate director of the AIDS Service at Hopkins Hospital.
Also, redirecting funds away from testing and treatment for prevention could have dire consequences. Those who are infected would continue to infect other people, Gallant said. About 20 percent of those infected don’t know their status, he said.
“Preventing HIV transition is the top priority,” he said. “We need figure out the economics of this and try and do it without de-funding treatment.”
