Physical inactivity kills 5 million a year: report

"A third of the world's adults are physically inactive, and the couch potato lifestyle kills about five million people every year, experts said in the medical journal The Lancet on Wednesday. (AFP Photo/Chip Somodevilla)" title

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Hepatitis C Virus Levels Higher in Certain Injection Drug Users

HealthDay – Fri, Jul 13, 2012 FRIDAY, July 13 (HealthDay News) -- Among injection-drug users in the United States infected with hepatitis C, virus levels are highest among blacks, males and those who are also infected with HIV, the virus that causes AIDS, a new study finds.

A 2010 report from the U.S. Centers for Disease Control and Prevention estimates that up to 3.9 million Americans have chronic hepatitis C infection, which is a leading cause of liver cancer, end-stage liver disease and liver transplantation.

The study was published in the July issue of the journal Hepatology.

Previous research indicates that one-third of injection-drug users aged 18 to 30 -- and up to 90 percent of older users -- are infected with the hepatitis C virus. With such high rates, it's important to learn more about the characteristics of infection in this group of people, Dr. Thomas O'Brien, of the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute, said in a journal news release.

O'Brien also noted that hepatitis C virus levels predict treatment response in people with chronic hepatitis C.

O'Brien and colleagues looked at approximately 1,700 black, Hispanic and white injection-drug users in San Francisco. Nearly 75 percent of the participants were men. Their average age was 46 and the average age at which they first used injection drugs was 18.

"We know that the level of

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Colorado says dentist put thousands at HIV risk from reused syringes

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Scientists see AIDS vaccine within reach after decades

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German doctors seek urgent action on circumcision row

"A rabbi carries an eight-day-old baby during a 2004 circumcision ceremony in Jerusalem. German doctors are seeking an urgent clarification from the government over religious circumcision after a court ruling calling it a criminal act prompted an international outcry. (AFP Photo/Menahem Kahana)" title

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Drugs 'arsenal' could help end AIDS: WHO

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Colorado Dentist Reused Needles, Putting Thousands at Risk

Since blood can stay in a syringe and needle after an injection, health officials said, that creates a risk of spreading blood-borne illnesses such as HIV and hepatitis if the implements are reused. Those who received IV medications are being urged to get tested for those viruses.

MORE: Can HIV Prevention be Found in a Pill?

The Denver Post reported state health director Dr. Chris Urbina said that as patients get tested, no infections have been reported yet. Stein’s license to practice medicine was suspended in 2011 due to an unrelated matter that hasn’t been disclosed.

Jeannine Stein, a California native, wrote about health for the Los Angeles Times. In her pursuit of a healthy lifestyle she has taken countless fitness classes, hiked in Nepal, and has gotten in a boxing ring. Email Jeannine

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Truvada Gets FDA Nod for HIV Prevention

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."

More from ABC News HIV Prevention Pill Strengthens BondCritics Pan HIV Prevention PillMajor Breakthrough in HIV PreventionHIV Prevention Setback: Drug Trial HaltedAntiretroviral Drugs May Prevent HIV InfectionAIDS Prevention Pill Ineffective for Women More Video » Related Topics: HIV, Infectious Diseases, Sexually Transmitted Diseases, Food And Drug Administration, Gilead Sciences, Contraception, Side Effects, U.S., Allergy, Kidney Health Follow

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FDA OKs 1st Pill to Help Prevent HIV

A bottle of antiretroviral drug Truvada is displayed at Jack's Pharmacy on Nov. 23, 2010 in San Anselmo, California. (Justin Sullivan/Getty Images)

The Food and Drug Adminstration today 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."

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FDA approves first pill to help prevent HIV

The Food and Drug Administration on Monday approved the first drug shown to reduce the risk of HIV infection, the latest milestone in the 30-year battle against the virus that causes AIDS.

The agency approved Gilead Sciences' pill Truvada as a preventive measure for healthy people who are at high risk of acquiring HIV through sexual activity, such as those who have HIV-infected partners. The decision comes less than two weeks after the agency approved another landmark product: the first over-the-counter HIV test that Americans can use in the privacy of their homes.

The two developments are seen as the biggest steps in years toward curbing the spread of HIV in the U.S., which has held steady at about 50,000 new infections per year for the last 15 years. An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. And it's estimated that one-fifth, or about 240,000 people, are unaware that they are infected.

"I think the combination of self-testing and a medicine that you can take at home to prevent infection could mean a whole new approach to HIV prevention that is a bit more realistic," said Dr. Demetre Daskalakis of New York University's Langone Medical Center, who served on the FDA panel that recommended approving Truvada. While a positive step forward, Daskalakis added that Truvada would likely be unavailable for many people without health insurance, who often face the greatest risk of acquiring HIV.

Researchers had long sought to create a pill that could help stem the epidemic. Public health advocates said Monday that Truvada represents a major breakthrough, both as a medical therapy and as a means of expanding other preventive measures. Patients who get a prescription for Truvada will be expected to take part in a comprehensive HIV prevention plan, which experts say will enhance the drug's impact.

"It really marks a new era in HIV prevention because in adding Truvada as a prevention strategy, what comes with it is expanded access to HIV testing, condoms and preventive counseling and support," said James Loduca, vice president of the San Francisco AIDS Foundation.

But HIV experts have raised concerns that patients might not use the drug correctly. Dr. Tom Giordano of Baylor College of Medicine said Monday the drug must be taken every day to be effective, and would be most effective for a relatively small group of people.

"It's been most effective in people who are at very high risk and are able to take the drug on a regular basis," said Giordano, who served on the FDA panel that recommended approving the drug. "When you really boil it down that's going to be a relatively focused population, but it's an important population to treat."

The drug's label carries a warning that people should be tested to make sure they don't have HIV before starting Truvada. Patients who already have the virus could develop resistance to the drug, making their disease more difficult to treat. The label also warns of side effects, including kidney and liver problems.

Gilead Sciences Inc. has marketed Truvada since 2004 as a treatment for people who are already infected with the virus. The once-a-day pill is a combination of two older HIV drugs, Emtriva and Viread.

Starting in 2010, studies showed that the drug could 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.

Because Truvada is on the market to manage HIV, some doctors already prescribe it as a preventive measure. FDA approval will allow Gilead Sciences to formally market the drug for that use, which could dramatically increase prescriptions.

Truvada's groundbreaking preventive ability has exposed disagreements about managing the disease among those in the HIV community. Groups including the AIDS Healthcare Foundation asked the FDA to reject the new indication, saying it could give patients a false sense of security and reduce the use of condoms, the most reliable preventive measure against HIV.

But FDA scientists said Monday said there was no indication from clinical trials that Truvada users were more likely to engage in risky sexual behavior.

"What we found was that condom use increased over time and sexually transmitted infections either remained at baseline levels or decreased," said Dr. Debra Birnkrant, FDA's director of antiviral products. "So in essence, we don't have any strong evidence that condoms were not used or there was a decrease in condom use."

Gilead Sciences said Monday that it would keep the pill at its current price, nearly $14,000 per year. Even at that price, HIV physicians said the drug could be cost effective if it prevents people from contracting the virus.

"It is expensive, but on the other hand it's far cheaper than a lifetime of HIV treatment," said Dr. Joel Gallant of Johns Hopkins University School of Medicine. "So if there are people who will not use condoms but are willing to use this, then for those people it's cost effective."

The lifetime cost of treating one person diagnosed with the AIDS virus has been estimated at more than $600,000.

The decision by the FDA on Truvada follows its approval of the OraQuick test earlier this month. The test, which detects the presence of HIV in saliva collected using a mouth swab and returns a result within 40 minutes, is aimed at people who might not otherwise be tested. The FDA has said the test is not 100 percent accurate.

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FDA Approves Truvada as First HIV Prevention Drug

in addition, patients must also practice safe sex, go through risk reduction counseling and undergo regular HIV testing.

Because of the stringent guidelines the FDA is strengthening the box warnings that patients must be confirmed that they’re HIV negative and must be tested for the virus every three months while they’re on the medication.

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Gilead wins first approval of drug to prevent HIV

Reuters – 21 hrs ago (Reuters) - Health regulators for the first time approved using an HIV drug to prevent infection in people who are at high risk of contracting the virus that causes AIDS.

Gilead Sciences Inc's Truvada was approved for people who are not yet infected but may engage in sexual activity with HIV-infected partners, a concept known as pre-exposure prophylaxis (PrEP).

Truvada, which combines two anti-HIV drugs in one pill, is already approved in combination with other antiretroviral agents to treat patients 12 years of age and older who are infected with the virus.

Under the new Food and Drug Administration approval Truvada taken daily, is to be used along with safer sex practices, risk reduction counseling and regular HIV testing to reduce the risk of sexually acquired HIV infection in adults deemed to be at high risk.

"Today's approval marks an important milestone in our fight against HIV," FDA Commissioner Margaret Hamburg said in a statement.

Every year, about 50,000 U.S. adults and adolescents are diagnosed with HIV infection, Hamburg said. "New treatments as well as prevention methods are needed to fight the HIV epidemic in this country."

A landmark study published in 2010 found that giving a daily dose of Truvada to men who have sex with other men could reduce HIV infection rates by 44 percent.

The use of combination therapies for people already infected with HIV has turned the virus that was once a sure death sentence into a condition people can live with for many years.

Meanwhile, researchers have been working for decades to come up with a vaccine that would prevent the virus from infecting people only to be disappointed time and again. A 2009 clinical trial in Thailand was the first to show it was possible to prevent HIV infection in humans, and more powerful vaccines using HIV-fighting antibodies are being studied amid renewed optimism that a vaccine may be within reach.

Debra Birnkrant, director of the Division of Antiviral Products at the FDA, said the federal government has a goal of a 25 percent decrease in HIV infections in the United States by 2015, and added that responsible use of Truvada for prevention could help achieve it.

In a conference call with reporters, Birnkrant was asked if the drug might give people a false sense of security that could tempt them to stop using condoms or otherwise engage in unsafe sex.

"We are concerned about risk-taking behavior, however, the (clinical) trials did not bear that out," she said. In one U.S. trial involving 400 men who have sex with other men, she said there was not an increase in unsafe sex.

"The hope is the right messages will get out and Truvada will be used properly," she said.

As part of the approval, the FDA is strengthening the warning label on the drug to make sure physicians screen individuals to ensure they are not infected with the HIV virus before prescribing the medication as a preventive measure, and at least every three months during use.

The approval comes with a risk mitigation program that includes training and education to assist prescribers in counseling people considering Truvada as a prophylaxis.

As a condition for approval, Gilead is required to collect samples from individuals who acquire HIV while taking Truvada and to evaluate them for potential resistance to the drug. It is also required to collect data on pregnancy outcomes for women who become pregnant while taking Truvada as prophylactic.

Gilead's shares closed up 1.5 percent at $51.94 on Nasdaq.

(Reporting by Toni Clarke in Boston and Ransdell Pierson and Bill Berkrot in New York; Editing by Maureen Bavdek, Bernard Orr)

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