Truvada, made by Gilead Sciences in California, has been on the market since 2004 and was approved by the Food and Drug Administration for a new use as a tool to help ward off HIV in otherwise healthy people, in combination with safe sex and regular testing. It was approved by the United States yesterday for use in uninfected adults who are at risk for getting the virus that causes AIDS.
The pill as pre-exposure prophylaxis (PrEP) has been hailed by some AIDS experts as a potent new tool against human immunodeficiency virus, but some health care providers are concerned it could encourage risky sex behavior.
Now, let’s try to understand this drug better.
The regimen is estimated to cost around $14,000 per year, making it out of reach of many.
“Truvada alone should not be used to prevent HIV infection,” said Debra Birnkrant, director of the division of antiviral products at the FDA. “Truvada as PrEP represents another effective, evidence-based approach that can be added to other prevention methods to help reduce the spread of HIV.”
The FDA said Truvada should be used as “part of a comprehensive HIV prevention strategy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.”
Truvada was previously approved as a treatment for people infected with HIV to be used in combination with other antiretroviral drugs.
The decision by the FDA followed the advice of an independent panel in May that supported Truvada for prevention in uninfected people, after clinical trials showed it could lower the risk of HIV in gay men and heterosexual couples.
One study on Truvada, called the iPrEx trial, published in 2010 in the New England Journal of Medicine included 2,499 men who were sexually active with other men but were not infected with the virus that causes AIDS.
Participants were selected at random to take a daily dose of Truvada — a combination of 200 milligrams of emtricitabine and 300 milligrams of tenofovir disoproxil fumarate — or a placebo.
Those in the study who took the drug regularly had almost 73 percent fewer infections. Across the entire study, including those who had not been as diligent in taking Truvada, there were 44 percent fewer infections than in those who took a placebo.
A second study on 4,758 heterosexual couples in which one partner was infected with HIV and the other was not, showed that Truvada reduced the risk of becoming infected by 75 percent compared with a placebo.
Experts have described the results as game-changing and the first demonstration that an already-approved oral drug could decrease the likelihood of HIV infections.
Common side effects were the same as experienced by people with HIV who were taking Truvada, and included diarrhea, nausea, abdominal pain, headache, and weight loss.
The drugmaker must also include a warning that Truvada for PrEP “must only be used by individuals who are confirmed to be HIV-negative prior to prescribing the drug and at least every three months during use.”
So, what do you think about Truvada? Would you rather abstain or use the drug? Do you think it would encourage risky sexual behavior among adults?
Please share your thoughts.
News Source: Vanguard