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Entries in Truvada (5)

Monday
Jul162012

FDA Approves Truvada for HIV Prevention

Justin Sullivan/Getty Images(WASHINGTON) -- The Food and Drug Adminstration Monday announced the approval of the first drug for use in people who are not infected with the human immunodeficiency virus (HIV), to prevent its transmission, which some are calling a landmark in the fight against AIDS.

The drug, Truvada, is actually a combination of two medicines and is manufactured by Gilead Sciences, Inc. of Foster City, Calif. While Truvada has been approved since 2004 as a treatment for those already infected with the HIV virus, this is the first time any drug has been approved for pre-exposure prophylaxis, or PrEP.

The study that led to the drug's approval found the risk of transmission among men who have sex with men decreased more than 40 percent. Furthermore, it showed a decrease of more than 70 percent in risk of transmission among heterosexual couples in which one partner was infected with HIV but the other was not.

"Truvada should not be used alone for preventing infections," cautioned Dr. Debra Birnkrant, director of the Division of Antiviral Products at the FDA's Center for Drug Evaluation and Research. "However, when used in combination with other prevention methods, such as safer sex practices, counseling, and regular testing to determine infection status, Truvada is effective in reducing the risk of transmission."

Other experts in the field agreed with this assessment.

"The approval of Truvada to prevent HIV infection in uninfected individuals who are at high risk of sexually acquired HIV infection is a significant development, providing an important addition to our toolkit of HIV prevention interventions," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Disease. "However, it is critical to stress that Truvada as 'pre-exposure prophylaxis' should not be considered a stand-alone method, but should be used in conjunction with other proven HIV prevention strategies."

Not everyone was in favor of the approval. The AIDS Healthcare Foundation, a global organization involved in providing treatment to AIDS/HIV patients, strongly criticized the move, calling it irresponsible and saying Truvada's approval for this use would undermine current prevention efforts.

AHF president Michael Weinstein questioned whether the fact that support provided to study participants -- such as monthly HIV testing and intensive counseling -- would not be available to the general population would lead to decreased adherence to the drug regimen, and thus to the development of drug-resistant strains. Weinstein further cautioned that the drug's side effects on the kidneys and bones might be worth accepting in patients who needed to be treated for HIV, but were not worth the risk on otherwise healthy individuals.

"Today marks a catastrophe in the history of AIDS in America," he said.

While the AHF criticized the approval, a number of experts said there are many high risk individuals who won't use condoms but might take a daily pill.

"It's argued that PrEP is far more expensive than condoms, but it's a lot cheaper than a lifetime of HIV treatment," said Dr. Joel Gallant of the Johns Hopkins Center for Global Health. "If we can target PrEP to those at highest risk, PrEP is likely to be cost-effective."

Copyright 2012 ABC News Radio

Monday
May212012

HIV Prevention Pill Truvada Helps Couple Cope with Stress of Virus

Justin Sullivan/Getty Images(SEATTLE) -- Nick Literski, 45, and Wes Tibbett, 39, have been together for six years, and their bond is strong.  But when Tibbett was diagnosed with HIV in 2009, it was a major blow to the Seattle couple.  Tibbett became terrified of giving the virus to Literski.

"I was heading down the road of not wanting to be around anymore because I felt too unsafe to be around him.  I was too afraid of infecting him," Tibbett said.

"When Wes became positive, it was a strain for both of us," Literski said.  "It's actually very common for people to break off their relationship when one partner contracts HIV."

According to the U.S. Center for Disease Control and Prevention, correct and consistent condom use greatly reduces the risk of HIV transmission.  So does being in a monogamous, long-term relationship.  But Tibbett and Literski still worried.

Both men started taking a daily pill called Truvada.  Tibbett took it as an HIV treatment six months after he was diagnosed, but in November 2010, the couple's doctor suggested Literski start taking the pill to prevent infection.  The men said the drug took the weight of worry about the virus out of their relationship.

"Condoms don't always work.  Sometimes they break," Tibbett said.  "If we're intimate and I have an accident, I'm not as worried for Nick."

Last week, an advisory panel recommended Truvada for approval by the U.S. Food and Drug Administration as a tool for HIV prevention, a landmark in the 30-year fight against the deadly virus.

Truvada was previously approved for treatment of HIV, and some people, like Literski, got the drug off-label as a prevention method.  But the advisory committee's vote officially recommends the use of the drug for preventing infection.

Proponents hailed the committee's vote on Truvada as an historic step in the fight against HIV/AIDS, but critics say the drug has the potential to create a false sense of security for those at risk, perhaps leading them to practice safe sex less diligently, thinking they are protected by the drug.

Copyright 2012 ABC News Radio

Wednesday
May092012

Critics Worry HIV Prevention Pill Will Promote Risky Behavior

Bananastock/Thinkstock(NEW YORK) -- AIDS advocates say a pill proven to protect against the HIV virus could promote unsafe sex by creating a false sense of security.

The U.S. Food and Drug Administration will meet Thursday to discuss whether Truvada, a drug already approved to manage HIV, should be approved to prevent the infection in high-risk patients, including men who have sex with other men, and heterosexuals with HIV-positive partners.  But advocacy groups argue the drug would encourage risky behavior and undo decades of safe-sex advocacy.

"I think it will be a catastrophe for HIV prevention in this country," said Michael Weinstein, president of the Los Angeles-based AIDS Healthcare Foundation, the largest provider of AIDS and HIV care in the U.S.  "Men don't need more excuses to not use condoms."

An estimated 1.2 million Americans have HIV, according to the Centers for Disease Control and Prevention.  Nearly half are men who have sex with men.

When taken daily, Truvada has been shown to cut the risk of HIV by up to 44 percent in gay and bisexual men in conjunction with condom use and counseling, and up to 75 percent in heterosexuals with HIV-positive partners.

"Why would a person use a condom if they're taking this serious, heavy duty medication?" said Weinstein.  "When used properly, condoms are 95 percent effective at preventing infection.  We don't want to reduce condom use."

Weinstein described the pill approach to HIV prevention as "the typical American easy way out" of a public health problem worthy of a bigger effort aimed at changing the culture of sex.

"We've done a really poor job in this country of promoting safer sex," he said, describing the "failure" of sex education in schools.  "It's not that safe sex has failed, it's that it's barely been tried in this country."

But Dr. Barry Zingman, medical director of the AIDS Center at Montefiore Medical Center in New York, said Truvada would give high-risk patients one more layer of protection.

"It's not a panacea by any means, but there is still a tremendous fear of becoming HIV-positive, even when couples are using all the proper protection," he said.  "When used in carefully selected patients getting significant support and close follow-up, it can clearly make a difference in people's lives."

Copyright 2012 ABC News Radio

Monday
Apr182011

HIV Prevention Drug Truvada: No Effect on Women

Romeo Gacad/AFP/Getty Images(DURHAM, N.C.) -- Prophylactic medicine widely used to prevent HIV infection among gay men appears to have no effect on women.

Researchers stopped one in a series of long-term studies testing the antiretroviral drug Truvada on thousands of African women who are at high risk of HIV infection after preliminary data showed an equal HIV infection rate among both women who took Truvada and those who took a placebo.

Many experts say they found the results of the study, known as FEM-PrEP, disappointing, since Truvada is regarded as a groundbreaking drug for HIV prevention among gay men. Researchers believed Truvada would also work for high-risk women in Africa.

"We were surprised by the outcome," said Dr. Timothy Mastro, vice president of health and developmental science at FHI, the nongovernmental organization that oversaw the study. "We were advised that there was no benefit to continue for the next several months."

A number of possible reasons could have contributed to the findings, according to Mastro. One reason, according to the organization, could be that the women may not have been taking the medication as advised, if they were taking it at all. Or the medication might not work for women the way it seemed to work for men.

"The final data have not been confirmed," said Mastro. "So at this point, all we can say is that the study was not able to conclude that Truvada works for women."

Copyright 2011 ABC News Radio

Tuesday
Nov232010

Preemptive Use of HIV Therapy May Prevent Virus Transmission

Photo Courtesy - Romeo Gacad/AFP/Getty Images(WALTHAM, Mass.) -- Antiretroviral drugs given as treatment of HIV/AIDS could prevent HIV infection if taken before exposure to the virus, according to a new study published Tuesday in the New England Journal of Medicine.

The study offered the first indication of an oral method to prevent the spread of HIV among those at high risk.

"We've known for some time that correct and consistent condom use is the best way to prevent transmission," said Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, an arm of the National Institutes of Health in Bethesda, Maryland, which partly funded the study. "We have had frustration all along in behavior modification programs -- getting people to use condoms, getting people to reduce the number of sexual partners."

Surpisingly, study participants who used the new oral method, called pre-exposure prophylaxis, or PrEP, reported a higher compliance with other HIV prevention methods such as condom use, and also reported a decrease in the number of sexual partners, Fauci said.

The study, called iPrEx, which began in June 2007, followed 2,499 men and transgendered women from six countries, including the U.S., who engaged in sexual intercourse with other men and were categorized as high risk for HIV infection.  Participants were randomized to either receive a combination antiretroviral drug commonly known as Truvada or a placebo.

Participants assigned to Truvada who reported taking the pills about half of the time they were prescribed had about a 50 percent lower risk of HIV infection.  Those who reported taking the medication about 90 percent of the time had a 73 percent lower risk of infection.

Although the study was limited to one type of high-risk group, other PrEP studies are looking at other groups at risk for transmission, including heterosexual couples and intravenous drug users. Researchers also plan to conduct a follow up study to iPrEx beginning 2011.

Copyright 2010 ABC News Radio







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