A drug hailed as a means to prevent HIV infection has won the approval of a FDA panel, which may result in the clearance of a daily drug designed to battle the growing rate of the viral infection.
It is reported that the Food and Drug Administration advisory panel recommended the drug Truvada, designed for daily intake through a series of votes in a meeting this week.
The drug can be prescribed for otherwise healthy people who are considered at ‘high risk’ of contracting the human immunodeficiency virus — including homosexual and bisexual men, and heterosexual couples who include one HIV-carrying partner.
Truvada has been marketed since 2004 as a treatment for those already carrying the virus. A combination of two older drugs, Emtriva and Viread, it is usually prescribed once an individual is already battling the condition.
The meeting eventually voted to recommend its daily use, but it did highlight a number of concerns. In particular, the potential of the drug lulling people into a false sense of security was raised — and whether it would result in the reduced use of condoms, which is currently one of the best ways to defend against HIV.
The drug’s effectiveness in women was also questioned, as clinical trials have shown a reduced level of protection for the fairer sex. In addition, whether individuals would adhere to the strict use of the drug was debated. One contributor told the panel:
“Truvada needs to be taken every day, 100 percent of the time, and my experience as a registered nurse tells me that won’t happen. In my eight years, not one patient that I’ve cared for has been 100 percent adherent.”
The drug does not offer full protection against the virus, but in a three-year study, the rate of infection was reduced by 75 percent in heterosexual couples using the drug as a preventative measure.
However, the panel stressed that users must be tested for HIV before the drug is used, as long-term use would only increase resistance to the drug, and make long-term treatment more difficult to achieve.
Over a million Americans are estimated to carry the HIV virus, with hundreds of thousands unaware of their condition. The rate of new infections over the last 15 years is approximately 50,000 per year. Homosexual and bisexual men account for almost two-thirds of these cases.
The advisory panel in question cannot enforce its recommendations, but usually the FDA does follow its advice. A final decision is expected in June this year.
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