Posts Tagged ‘Truvada’

Condoms vs PrEP

Substantial Minority’ of MSM Would Use Condoms Less When on PrEP

 A “substantial minority” of men who have sex with men (MSM) anticipated that they would use condoms less if they were taking PrEP, or pre-exposure prophylaxis, according to results of a survey  presented Tuesday, July 24, at the XIX International AIDS Conference in Washington, DC.

Specifically, 20 percent of 3,245 respondents said they would decrease condom use while “topping”—engaging in insertive anal sex—while using PrEP.
And 14 percent of 3,237 respondents said they would forgo condoms while “bottoming”—engaging in receptive anal sex—while taking PrEP.

PrEP, which is when an HIV-negative person takes daily medication to prevent potential infection, is a controversial and timely topic. The Food and Drug Administration this month approved the use of the antiretroviral Truvada (tenofovir plus emtricitabine) as PrEP.

A 2010 study called iPrEx showed that among men who have sex with men (MSM) and transgender women, Truvada as PrEP reduced HIV infections by 42 percent. However, not everyone took the meds as prescribed.
Those who followed the daily regime received higher protection—as much as 92 percent.
But in real world settings, will PrEP’s potential benefit be reduced by risk compensation?
In other words, will men who take PrEP perceive themselves to be protected and as a result stop using condoms?
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The U.S. Food and Drug Administration (FDA) has approved Truvada as the first prescription drug—to be used daily and in conjunction with condoms and other safer-sex measures—to prevent HIV among those at high risk for the infection.

Truvada’s approval as pre-exposure prophylaxis (PrEP) was announced via statements from both the FDA and Truvada’s manufacturer, Gilead Sciences.

“As part of PrEP, HIV-uninfected individuals who are at high risk will need to take Truvada daily to lower their chances of becoming infected with HIV should they be exposed to the virus,” the FDA said.

“Truvada for PrEP is meant to be used as part of a comprehensive HIV prevention plan that includes risk reduction counseling consistent and correct condom use, regular HIV testing, and screening for and treatment of other sexually-transmitted infections.

Truvada is not a substitute for safer sex practices.”

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Drug to Prevent HIV

The first drug shown to prevent HIV infection won the endorsement of a panel of federal advisers Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

  • In a series of votes, a Food and Drug Administration advisory panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

The FDA is not required to follow the panel’s advice, though it usually does. A final decision is expected by June 15.

Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe it as part of a drug cocktail to repress the virus.

While panelists ultimately backed Truvada for prevention, Thursday’s 12-hour meeting highlighted a number of concerns created by the first drug to prevent HIV. In particular, the panel debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug’s effectiveness in women, who have shown much lower rates of protection in studies.

Panelists struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who didn’t take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.

“The trouble is adherence, but I don’t think it’s our charge to judge whether people will take the medicine,” said Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug. “I think our charge is to judge whether it works when it’s taken and whether the risks outweigh the benefits.”

Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42 percent, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75 percent in heterosexual couples in which one partner was infected with HIV and the other was not.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval would allow Gilead Sciences to formally market its drug for that use.

But Truvada’s groundbreaking preventive ability has exposed stark disagreements on prevention among those in the HIV community. While Truvada’s supporters say the drug is an important new option, critics worry that the drug could give users a false sense of security, and encourage risky behavior.

Other speakers worried that wide scale use of Truvada would divert limited funding from more cost-effective options. Truvada sells for about $900 a month, or just under $11,000 per year. The AIDS Healthcare Foundation, which opposes approval of Truvada, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with preventive Truvada.

“Truvada for prevention will squeeze already-constrained health care resources that can be better spent on cheaper and more effective prevention therapies,” the group states in a petition to the FDA.

The FDA is legally barred from considering cost when reviewing drugs. Medicare and Medicaid, the nation’s largest health insurance plans, generally cover all drugs approved by the FDA and many large insurers take their cues for coverage from the government plans.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body’s immune system to breakdown, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases — nearly two-thirds.

The number of new HIV infections in the U.S. has held steady for 15 years at about 50,000 per year. But with no vaccine in sight and an estimated 240,000 HIV carriers unaware of their status, doctors and patients say new methods are needed to fight the spread of the virus.

Nick Literski, a federal worker in Seattle, has been taking Truvada for HIV prevention for more than a year. His partner is HIV-infected and his doctor prescribes the drug as a precautionary measure, even though it is not yet FDA-approved for that use. Literski pays a $40 monthly co-pay for the once-daily pill.

FDA approval of the drug for prevention would be “a huge step forward” in the fight against AIDS, he said in an interview Thursday. But he said rejection would be devastating, threatening gay relationships like his that involve one partner who is HIV infected and one who isn’t.

“Many HIV-positive men end up ending their relationships with HIV-negative men out of fear of infecting their partner,” Literski said, and he worried about that happening to him before he started using Truvada.


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The PrEP study using Truvada

Mark King in his blog My Fabulous Disease summarizes this important debate raging among AIDS advocates right now – does PrEP (pre-exposure prophylaxis) help or hurt prevention efforts? PrEP, in layman’s terms, is the strategy of giving a pill regimen to people at risk of contracting HIV – the regimen appears partially effective, in early studies, in keeping them from becoming HIV infected. The AIDS Healthcare Foundation, for one, has gone on record saying “there is no magic pill,” because they fear PrEP will lead to riskier behavior. But other HIV advocates, like many involved in IRMA (International Rectal Microbicide Advocates) believe PrEP is worthy of further investigation. Yes this sounds wonky, but trust me, it has everything to do with the future of HIV prevention and it’s worth your browsing these links and forming your own opinion.

Response from ACT NOW – Choice in HIV Prevention

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Truvada slashes HIV Infection Risk in ‘Breakthrough’ Study

This past week a study was released that showed giving HIV-negative men Truvada significantly reduced the percentage of them becoming positive.

About 2,500 trial participants were divided into two groups. One group was given Truvada, the other a look-a-like placebo. Both groups were also given condoms, counseling on safe sex, and tested for HIV and other STD’s once a month. They also returned their pill bottles to see how diligent they were taking the drug. The trial lasted a little longer than a year.

A total of 100 men contracted HIV during the trial, 36 of them were on Truvada and 64 were on the placebo. That translates into a 44% reduction in risk.

Truvada costs between $5,000 and $7,000 a year in the U.S. when purchased through the health care system and more if bought privately.

My Comments: Forgive me for being cynical, BUT we talked about this concept at least two years ago in group with a slightly different slant. The street has been using Truvada to prevent HIV infection for years as part of the Party-n-Play-Cocktail. The PnP-Cocktail consists of 3 drugs; Crystal Meth to get high and remove inhibitions, Vigra to keep an erection (Erectile Dysfunction is a common side effect of Crystal Meth) , and Truvada to prevent HIV infection allowing people to practice unsafe sex totally uninhiiBBited (BB= BareBack). By taking all three drugs, the idea is that you can stay up all weekend having unprotected sex and then go back to work on Monday HIV-negative.

Although the Gilead study is more scientific than the street experiment, I’m not sure a reduction of 44% over just a year is the “end of the AIDS” in the Gay community. Combining that with the cost of Truvada at $5-7,000/year and I also don’t put much faith in the idea that we have the tools “to break the back of the epidemic”.

We don’t know the long-term side-effects of taking Truvada or any anti-HIV medication over a lifetime. HIV is only 30 years old and these HIV medications are still within their patent period.

Even if Truvada became readily available at affordable rates, would Gay men who were using condoms, abandom them for Truvada? These are questions that need to be answered before we jump on the bandwagon that the AIDS epidemic is over.

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