Taking Anti-HIV Meds Prior to Exposure May Help Prevent Infection

TUESDAY, May 29 (HealthDay News) -- Preventive antiretroviral treatment appears to be an effective way to help protect high-risk people against HIV infection, a new study suggests.

HIV, the virus that causes AIDS, can be transmitted through unprotected sex and contaminated needles.

Immediate treatment after HIV exposure can be successful in preventing HIV infection, previous research has found. More recently, several large randomized, controlled trials -- the gold standard of medical research, in which people are randomly assigned to treatment or no treatment -- have shown that giving antiretroviral drugs before people are exposed may also prevent infection.

For the new report, published May 28 in the CMAJ (Canadian Medical Association Journal), researchers reviewed studies published between January 1990 and April 2012 and found that preventive antiretroviral treatment could reduce the risk of HIV infection in high-risk groups such as gay men, intravenous drug users, and women in areas with high rates of HIV.

For example, one recent study that included 900 women from a region with a high rate of HIV found that applying a topical vaginal microbicide 12 hours before and after sex led to a 39 percent reduction in HIV infection rates.

"All pre-exposure prophylaxis [prevention] interventions should be considered one part of a more comprehensive plan for preventing the spread of HIV infection, including standard counseling on safer sexual practices and condom use, testing for and treating other sexually transmitted infections and, in select circumstances, male circumcision and needle exchange programs," Dr. Isaac Bogoch of Harvard Medical School and Massachusetts General Hospital in Boston, and colleagues wrote.

While pre-exposure treatment is promising, there are a number of unanswered questions, such as which groups would benefit most, and the possibility of the development of drug resistance, the researchers noted.

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The U.S. Centers for Disease Control and Prevention has more about HIV transmission.

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FDA delays decision on first drug to prevent HIV

WASHINGTON (AP) — Federal health regulators have delayed a decision on whether to approve the first pill shown to prevent HIV infection, the drug's manufacturer says.

Gilead Sciences disclosed Friday that the Food and Drug Administration will take three more months to review its application for Truvada, after the company submitted additional materials to the agency earlier this month.

In May, a panel of experts recommended approval of the daily pill for healthy people who are at high risk of contracting HIV, including gay and bisexual men. The vote was nonbinding, though the FDA often follows the group's advice.

Gilead said it submitted updated information on its planned safety materials for patients and doctors using the drug. The FDA typically extends its reviews after receiving such information.

The FDA is now expected to rule by Sept. 14, the company said in a statement.

Gilead Sciences Inc., based in Foster City, Calif., 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.

Truvada made headlines in 2010, when government researchers showed it could actually prevent people from contracting HIV when used as a precautionary measure. 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.

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 break down, leading to infections which are eventually fatal. Gay and bisexual men account for the majority of cases — nearly two-thirds.

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 to stop the spread of AIDS, critics worry that the drug could give users a false sense of security and encourage risky behavior.

Groups including the AIDS Healthcare Foundation have asked the FDA to reject the new indication, saying it could reduce use of condoms, the most consistently reliable prevention against HIV.

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

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FDA Seems to Back Pill to Help Prevent HIV

WEDNESDAY, May 9 (HealthDay News) -- U.S. Food and Drug Administration advisers will meet Thursday to decide whether to endorse the use of the drug Truvada as a means to help prevent HIV infection in people at high risk.

Those individuals might include highly sexually active gay or bisexual men, or the partners of people already infected with HIV, the virus that causes AIDS.

A report released by the FDA this week ahead of Thursday's meeting suggests that experts do believe the drug is safe and effective for this use.

There are potential drawbacks to using the medication in this way, however. Truvada -- which combines two HIV-fighting drugs, tenofovir (Viread) and emtricitabine (Emtriva) -- is very expensive and may cause side effects. And although doctors can already prescribe it to people trying to avoid HIV infection, critics say it's too early to officially allow it to be promoted for that use.

On the other hand, those who support marketing the drug as a preventive agent say it can help high-risk people avoid the disease, especially if they don't use condoms or if they want an added layer of protection.

"I don't see it as a panacea, but it's an option, and that's important," said Dr. Kenneth Mayer, an AIDS specialist and medical research director of The Fenway Institute at Fenway Health in Boston. "Some people won't use a condom, but will say, 'if you give me another option, I'll use that.'"

Truvada works to prevent HIV from replicating in the body's cells. Mayer explained that in someone who is not yet infected but is exposed to HIV, the drug may prevent the virus from reproducing even if it's already invaded cells. As a result, he said, "the virus cannot start turning the newly exposed person's body into a 'factory' to produce more HIV particles."

A study published in 2010 in the New England Journal of Medicine found that Truvada cut the risk of HIV infection by almost 44 percent in those at highest risk for contracting the virus, namely sexually active gay and bisexual men. The risk reduction climbed to nearly 73 percent among study participants who took the pill 90 percent of the time, the researchers added.

On Thursday, the FDA advisory panel will meet and come up with advice for federal officials about the possible marketing of the drug as a preventive agent by its manufacturer, Gilead Sciences.

The research suggests that people who use Truvada daily along with condoms would gain an added layer of protection, because condoms aren't 100 percent effective. But one organization, the AIDS Healthcare Foundation, worries that wider use of the drug could lead to more infections by discouraging people from bothering to use condoms.

"Why would you take this medication if you intended to use condoms?" asked the group's president, Michael Weinstein, in an interview with Bloomberg News. He used a sartorial metaphor to elaborate how unlikely that might be: "You've got to be really paranoid about your pants falling down to wear a belt and suspenders."

A. David Paltiel, a professor at Yale School of Medicine, said his research has shown that the use of preventive drug treatments should reduce the risk of infection overall. Still, he said, it's unknown if "people (would) take more chances because they feel protected by a 'chemical condom.'"

Potential markets for Truvada as a preventive drug, Mayer said, include gay men who have sex with more than one man and any committed couple in which one person is HIV-positive, including some heterosexual couples who want to have children.

Mayer, who has conducted research into the drug, said that allowing the marketing will probably lead to an increase in its usage for prevention. But, "this is not a one-time, end-of-the-problem approach like a shot of penicillin to treat an infection like syphilis," he said. "Also, it involves someone perceiving that he or she is at risk, or a provider being comfortable enough to ask about a person's risk. We know that a lot of health providers don't like to talk to their patients about sex."

Truvada can also cause a long list of side effects, including gastrointestinal problems. And it's costly, with prices in the United States tagged at about $26 a day or $10,000 a year. Still, a study released this year found the drug would be cost-effective if used extensively by gay and bisexual men at high risk of becoming infected.

For his part, Paltiel said his research came to the same conclusion: That widespread usage of the drug in high-risk people would be "as cost-effective as other widely accepted public health and medical interventions."

More information

Find out more about HIV/AIDS at the U.S. National Library of Medicine.

View the original article here

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FDA Advisers Back Pill to Help Prevent HIV Infection

THURSDAY, May 10 (HealthDay News) -- U.S. Food and Drug Administration advisers on Thursday endorsed the use of the drug Truvada as a means to help prevent HIV infection in healthy people at high risk of contracting the AIDS-causing virus.

In a series of votes that could lead to a major new weapon in the fight against AIDS, the FDA advisers recommended approval of the daily pill for healthy, at-risk individuals, including gay and bisexual men and heterosexual couples with one HIV-infected person, the Associated Press reported.

The FDA is not bound to follow the recommendations of its advisory panels, but it typically does so. A final decision is expected by mid-June.

A report released earlier this week by the FDA suggested that scientists believe the drug is safe and effective. It has been available since 2004 to treat people already infected with HIV.

But there are potential drawbacks to using the medication as a way to try to prevent HIV infection. Truvada -- which combines two HIV-fighting drugs, tenofovir (Viread) and emtricitabine (Emtriva) -- is very expensive and may cause side effects. And although doctors can already prescribe it to people trying to avoid HIV infection, critics contend it's too early to officially allow it to be promoted for that use.

On the other hand, those who support marketing the drug as a preventive agent say it can help high-risk people avoid the disease, especially if they don't use condoms or if they want an added layer of protection.

"I don't see it as a panacea, but it's an option, and that's important," said Dr. Kenneth Mayer, an AIDS specialist and medical research director of The Fenway Institute at Fenway Health in Boston. "Some people won't use a condom, but will say, 'if you give me another option, I'll use that.'"

Truvada works to combat HIV from replicating in the body's cells. Mayer explained that in someone who is not yet infected but is exposed to HIV, the drug may prevent the virus from reproducing even if it has already invaded cells. As a result, he said, "the virus cannot start turning the newly exposed person's body into a 'factory' to produce more HIV particles."

A study published in 2010 in the New England Journal of Medicine found that Truvada cut the risk of HIV infection by almost 44 percent in those at highest risk for contracting the virus, namely sexually active gay and bisexual men. The risk reduction climbed to nearly 73 percent among study participants who took the pill 90 percent of the time, the researchers added.

Research suggests that people who use Truvada daily along with condoms would gain an added layer of protection, because condoms aren't 100 percent effective. But one organization, the AIDS Healthcare Foundation, worries that wider use of the drug could lead to more infections by discouraging people from bothering to use condoms.

"Why would you take this medication if you intended to use condoms?" asked the group's president, Michael Weinstein, in an interview with Bloomberg News. He used a sartorial metaphor to elaborate how unlikely that might be: "You've got to be really paranoid about your pants falling down to wear a belt and suspenders."

A. David Paltiel, a professor at Yale University School of Medicine, said his research has shown that the use of preventive drug treatments should reduce the risk of infection overall. Still, he said, it's unknown if "people (would) take more chances because they feel protected by a 'chemical condom.'"

Potential markets for Truvada as a preventive drug, Mayer said, include gay men who have sex with more than one man and any committed couple in which one person is HIV-positive, including some heterosexual couples who want to have children.

Mayer, who has conducted research into the drug, said that allowing the marketing will probably lead to an increase in its usage for prevention. But, "this is not a one-time, end-of-the-problem approach like a shot of penicillin to treat an infection like syphilis," he said. "Also, it involves someone perceiving that he or she is at risk, or a provider being comfortable enough to ask about a person's risk. We know that a lot of health providers don't like to talk to their patients about sex."

Truvada, which is manufactured by Gilead Sciences, can also cause a long list of side effects, including gastrointestinal problems. And it's costly, with prices in the United States tagged at about $26 a day or $10,000 a year. Still, a study released this year found the drug would be cost-effective if used extensively by gay and bisexual men at high risk of becoming infected.

For his part, Paltiel said his research came to the same conclusion: That widespread use of the drug in high-risk people would be "as cost-effective as other widely accepted public health and medical interventions."

More information

Find out more about HIV/AIDS at the U.S. National Library of Medicine.

View the original article here

Read more »