UPDATE- Federal health regulators have delayed a decision on whether to approve the first pill shown to prevent HIV infection, the drug’s manufacturer says.
Gilead Sciences disclosed Friday that the Food and Drug Administration will take three more months to review its application for Truvada, after the company submitted additional materials to the agency earlier this month. (AP)
In May, a panel of experts recommended approval of the daily pill for healthy people who are at high risk of contracting HIV, including gay and bisexual men. The vote was nonbinding, though the FDA often follows the group’s advice.
If this drug is approved by the FDA (Food and Drug Administration) it will be the first agent indicated for uninfected individuals to reduce the risk of acquiring HIV through sex.
Foster City drugmaker Gilead updated its application with the FDA for approval to market a medication known as Truvada as a HIV prevention pill. However, a move like this is rubbing many public health advocates the wrong way. They say that the wide availability of the drug would discourage safe sex and actually increase the rate of HIV.
Clinical trials supported by the National Institutes of Health have shown that when taken daily, Truvada, a blue oval pill, reduced the risk for contracting HIV by between 44 percent among gay men in four countries and 73 percent by heterosexual couples in Uganda and Kenya. One trial among women in sub-Saharan Africa was stopped in April 2011.
Some are still fearful and skeptical of this drug.
“I believe that this could be catastrophic in terms of HIV prevention,” said Michael Weinstein, president the AIDS Healthcare Foundation, based in Los Angeles. 42,000 people with HIV are already living in California.
This is another chapter of an ongoing discussion about the use of this drug. Various articles have been written about Truvada, and several press conferences have been held where people discussed this topic.
Do you feel the delay could be a good thing for the drug? Share your thoughts.