HIV prevention drug is now available. Would you risk your life to use it?
By Marie Cendejas
According to ABC News, the Food and Drug Administration (FDA) announced its approval of the first drug intended for healthy people to use to prevent them from getting HIV infection.
Truvada, a combination of two medicines, is manufactured by Gilead Sciences, Inc. based out of Foster City, California. Truvada has been approved since 2004 as a treatment for those who are already infected with the HIV. For the first time the drug was approved for pre-exposure prophylaxis, or PrEP.
The study that led to the drug's approval found the risk of transmission among men who have sex with men, who are a high risk for acquiring HIV and spreading the disease to others, was lowered more than 40%. It showed a decrease of more than 70% in risk of transmission among heterosexual couples in which one partner was infected with HIV but the other was not.
"Truvada should not be used alone for preventing infections. However, when used in combination with other prevention methods, such as safer sex practices, counseling, and regular testing to determine infection status, Truvada is effective in reducing the risk of transmission," cautioned Dr. Debra Birnkrant, director of the Division of Antiviral Products at the FDA's Center for Drug Evaluation and Research.
Other experts in the field agreed with this assessment.
"The approval of Truvada to prevent HIV infection in uninfected individuals who are at high risk of sexually acquired HIV infection is a significant development, providing an important addition to our toolkit of HIV prevention interventions. However, it is critical to stress that Truvada as 'pre-exposure prophylaxis' should not be considered a stand-alone method, but should be used in conjunction with other proven HIV prevention strategies," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Disease.
Not everyone was in favor of the approval.
The AIDS Healthcare Foundation strongly criticized the move, calling it irresponsible and saying Truvada's approval for this use would damage current prevention efforts.
The AHF president Michael Weinstein questioned the fact that support provided to study participants (such as monthly HIV testing and intensive counseling) wouldn’t be available to the general population would lead to a lower adherence to the drug regimen, and the development of drug-resistant strains.
He further cautioned that the drug's side effects on the kidneys and bones might be worth accepting in patients who needed to be treated for HIV, but were not worth the risk on otherwise healthy individuals.
"Today marks a catastrophe in the history of AIDS in America," he said.
While the AHF criticized the approval, but a number of experts said there are many individuals with a higher risk who won't use condoms but might take a daily pill.
"It's argued that PrEP is far more expensive than condoms, but it's a lot cheaper than a lifetime of HIV treatment. If we can target PrEP to those at highest risk, PrEP is likely to be cost-effective," said Dr. Joel Gallant of the Johns Hopkins Center for Global Health.
A health observer suggested that the approval and availability of the drug could mislead people to engage themselves in unsafe sexual acts more often while its efficacy is quite limited. He urged consumers to continue using the conventional prevention measures such as condoms etc.
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