Truvada, the first anti-AIDS preventive drug marketed in the U.S.

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truvada-anti-aidsJuly 18, Washington: Truvada, the first AIDS treatment, will be marketed in the United States. The U.S. agency (FDA) has given the green light Monday. This antiretroviral U.S. laboratory Gilead Sciences is intended for people at risk but not infected with AIDS. This should help, according to authorities, to reduce new infections.

Truvada, taken daily, is intended “to be used prophylactically before contact with HIV (human immunodeficiency virus), in combination with safer sex practices like condom use and other preventive measures – regular screening and treatment of other sexually transmitted diseases, to prevent transmission of the virus among adults at high risk, “said the agency. “Truvada is not a substitute for safe sex,” insists the FDA in a statement.

The approval comes just before the International AIDS Conference to be held in Washington from July 22 to 27 and whose theme is: “Turning the tide of the pandemic” to end it. “The approval of Truvada is a milestone in our fight against HIV,” said Margaret Hamburg, director of the FDA. “Each year about 50,000 American adults and adolescents are diagnosed with HIV infection despite the availability of prevention methods, educational strategies, screening tests and treatment for people living with the virus,” she says in a statement.

The objective in the United States is “to reduce the number of new infections by 25% by 2015,” also said at a press conference Dr. Debra Birnkrant, director of the division of the antiviral FDA. And “we expect that the approval of Truvada helps to achieve this goal,” she added.

The cost of this treatment varies from 12 000 to 14 000 dollars per year. The preventive efficacy of Truvada has been highlighted by the results of a clinical trial with 2,499 HIV-negative homosexual men from 2007 to 2009 in six countries, including Brazil, South Africa, and the USA, and funded largely by the U.S. National Institutes of Health (NIH). He has then reduced by 44% the risk of infection among participants who used a condom as compared to those undergoing placebo.Une another clinical study with 4875 heterosexual couples showed a decreased risk of infection up to 75 % among HIV-negative partners who took Truvada compared to controls.

Truvada, a combination of two antiretroviral drugs, was originally approved by the FDA in August 2004 for use with other antiretrovirals to treat HIV-affected adults and children 12 years and over. No new side effects have been identified in recent clinical trials designed to evaluate the preventive capacities of Truvada. The most common side effects are diarrhea, nausea, abdominal pain, headaches and weight loss and more serious, very rare, affecting the kidneys and bones.

The head of the NGO, AIDS Healthcare Foundation, Michael Weinstein said it was “irresponsible” the FDA’s decision to authorize the Truvada as a preventive treatment without “testing requirement” of HIV. He said it “will eventually decline to the prevention efforts carried out over several years.”

News Gathered by India News

Posted by on Wednesday, July 18th, 2012. Filed under Health, Life Style. You can follow any responses to this entry through the RSS 2.0. You can skip to the end and leave a response. Pinging is currently not allowed.

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