WASHINGTON Only high-risk gay and bisexual men should use Gilead's HIV drug Truvada to protect themselves from the AIDS virus, federal officials said on Thursday in the first official guidance on using the drug.
A study published last November showed that the pill, which combines two AIDS drugs, reduced the HIV infection rate by nearly 44 percent in high-risk gay and bisexual men. [ID:nN2287379]. It worked even better if the men used the drug consistently.
Some doctors have already been using the experimental approach, called pre-exposure prophylaxis, or PrEP for short. This use of the drug is not approved by the U.S. Food and Drug Administration, which has approved Truvada for treating HIV infection.
But the U.S. Centers for Disease Control and Prevention decided to issue some guidance for doctors who may want to prescribe the drug to protect people at very high risk of infection with the fatal and incurable virus.
"Concerns exist that without early guidance, various unsafe and potentially less effective PrEP-related practices could develop among health-care providers and MSM (men who have sex with men) beginning to use PrEP in the coming weeks and months," the CDC says in its guidance.
For instance, people might be tempted to use other HIV drugs, which have not been shown to prevent infection, they might just take the pills occasionally, they might not get screened for infection first and they might not get the needed counseling.
'SATURDAY NIGHT SPECIAL'
"Let's be really clear -- the use of this medication is not a license for unsafe sex and it's not a Saturday night special," said Dr. Michael Horberg, vice chairman of the HIV Medicine Association and director of HIV and AIDS for Kaiser Permanente in California.
"You can't just pop a pill as you are getting ready to go out Saturday night."
The CDC guidelines stress this.
"Until the safety and efficacy of PrEP is determined in trials now under way with populations at high risk for HIV acquisition by other routes of transmission, PrEP should be considered only for men who have sex with men," the guidelines say.
High-risk gay and bisexual men include those who have frequent, unprotected sex with others.
Patients should be tested to make sure they do not have HIV and they need to be counseled about other ways to protect themselves, including consistent use of condoms, the CDC said.
"Health-care providers should report any serious adverse events," the guidance adds.
Horberg said the advice was "reasoned" and said only doctors experienced with HIV medications should consider prescribing PrEP for patients.
"This really is going to have fall in the hands of HIV and infection specialists," he said.
Horberg also said it is unclear who will pay for such treatment. Insurers usually do not pay for treatments not approved by the FDA, even though licensed doctors are legally free to prescribe any approved drug as they see fit.
Truvada costs $1,000 a month in the United States.
"The drug is only one element of the whole process," Horberg said.
"There is the monitoring, the office visits, correct prevention counseling -- trying to ensure that the patients are also using condoms, etc.," he said.
Regular tests will be needed to ensure the drug is not damaging the bones or kidneys, he added -- known side-effects of HIV drugs.
"We don't know the real long-term effects of these medications in HIV non-infected patients," he said.
(Editing by Eric Beech)