WASHINGTON. History in the making. The first ever daily pill to prevent contaction of HIV was approved on monday by US regulators. This pill is to by uninfected people who are at hig risk of exposure.
WASHINGTON. History in the making. The first ever daily pill to prevent the contaction of HIV was approved on monday by US regulators. This pill is to be used in uninfected adults who are at high risk of contacting the virus that causes AIDS. This is a welcome developement and a wonderful breakthrough in research. Truvada, the name given to the drug is made by Gilead Sciences in California, and has been on the market since 2004 was approved by the Food and Drug Administration for a new use as a preventive tool to help ward off HIV in otherwise healthy and uninfected people, in combination with safe sex and regular testing. ￼ Truvada The pill as pre-exposure prophylaxis (PrEP) has been hailed by some AIDS experts as a potent new tool against human immunodeficiency virus. However, some critics and health care providers have expressed concern that it could encourage risky sex behavior especially among youths and adults. Adding, the regimen is expensive and out of reach of many at an estimated cost of around $14,000 per year. “Truvada alone should not be used to prevent HIV infection,” Decleared 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 in the world.” The FDA said Truvada should be used as “part of a comprehensive HIV prevention strategy/ therapy that includes other prevention methods, such as safe sex practices, risk reduction counseling, and regular HIV testing.” Truvada was previously approved as a treatment therapy for people infected with HIV to be used in combination with other antiretroviral drugs namely Nevarphine, Stavudine etc. 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. A 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. other studies has been documented Experts described the result of these studies as game-changing and the first demonstration that an already-approved oral drug could decrease the chances of HIV infections. Although the down side is the common side effects which are same as those experienced by people with HIV who were taking Truvada, which includes diarrhea, nausea, abdominal pain, headache, nightmare and weight loss. However, adherence rates — meaning how often people in the study actually took the drug daily — were low in the study of men who have sex with men, just 30 percent, said Birnkrant. In the study of heterosexual partners, adherence was much higher, between 80 and 90 percent. Therefore, the drug label must include specific instructions for health care providers on how to counsel potential users of the drug. The producer of the drug must 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 HIV testing should been carried out during drug use.” Gilead Sciences is also mandated to collect samples from people who test positive for HIV while taking the therapy and analyze them for signs of drug resistance and possible improvement. As to critics that says the pill would boost risky sex practices/ behavior and make people abandon condoms as a first line of protection, Birnkrant said the studies have not shown that so far. “We don’t really have any strong evidence to show that condoms were not used or that there was a decrease in condom use when Truvada was used,” she said. If you can’t tell if condoms were used or not? How can u now attribute the result to Truvada? Hmmm.. Interestin isn’t it. The approval of the drug is with the sole aim of reducing the rate of new infections in the United States, which have stayed put in recent years at about 50,000 annually, she said thereby achieving a key goal in decreasing new infections by 25 percent by 2015.