The group urged to take the pills includes people with HIV-infected partners and those who inject illicit drugs and share equipment, or have been in treatment programs for injection medicine use, the Centers for Disease Control and Prevention said Wednesday in a statement. Gilead Sciences’ anti-AIDS pill Truvada has been approved as a preventative medicine for the virus that causes AIDS.
Also advised to take the medicines are heterosexual men or women who don’t always use condoms with at-risk partners and gay or bisexual men who have sex without a condom or are not in mutually exclusive relationships with partners testing HIV- negative, the agency said.
For HIV, “there’s no vaccine and cure in the near horizon. Prevention is key,” Jonathan Mermin, director of the CDC’s national center for HIV/AIDS, Viral Hepatitis, STD and TB prevention, said in a telephone interview.
PrEP, or pre-exposure prophylaxis, is a step toward combating the AIDS-causing virus that infects 50,000 new patients each year in the U.S. Gilead’s Truvada was approved for sale by the U.S. Food and Drug Administration in 2012 to be used as part of a prevention strategy that included safe sex practices and regular HIV testing.
“It’s a potentially life-saving tool,” Mermin said. Fewer than 10,000 people are prescribed the drugs for prevention while about almost 500,000 are eligible.
Mermin said the CDC’s new guidelines are to promote mass distribution of the pills and the agency is working with other health organization to conduct pilot programs to demonstrate the effectiveness of the approach. The recommendations follow interim guidelines on the prevention strategy issued in August 2012.
Truvada, a combination of two drugs from Gilead, is usually covered by insurance, Mermin said.
The medicine generated more than $3.1 billion in sales last year for Foster City, California-based Gilead, the world’s largest maker of HIV medicines.
While the drug costs about $15,000 a year in the U.S., “it is important to note that those taking Truvada for PrEP may not take it for an entire year,” said Cara Miller, a Gilead spokeswoman, in an email. The company also assists patient who need the medicine but aren’t covered by insurance, she said.
For many, cost is an inhibiting factor in using the medicine as a preventative, said Victoria Richards, associate professor of medical sciences the Frank H. Netter School of Medicine at Quinnipiac University in North Haven, Connecticut.
“In other countries, companies have reduced the cost of the medication, and that’s where research is coming from,” Richards said in a telephone interview.
A push for the drug “on this type of a scale with the CDC involved, there might be some type of mechanism in place to alleviate the cost of the medication,” she said.
The AIDS Healthcare Foundation, a Los Angeles-based non-profit that provides medical care to more than 300,000 patients, said they oppose the recommendation. The group said it could lead to a decline in use of condoms, which can prevent the spread of other sexually transmitted diseases.
There is also a concern that patients won’t take the drug as directed, the AFP said in a statement.
“This is a position I fear the CDC will come to regret,” said AFP president Michael Weinstein in a statement.
By making the recommendation, “the CDC has abandoned a science-driven, public health approach to disease prevention - a move that will likely have catastrophic consequences in the fight against AIDS in this country,” he said.
The FDA and CDC urge HIV testing before prescribing the drug as a preventative and at three month intervals while using the medicine. If patients contract HIV, they should discontinue using the drug, or else risk that the virus becomes resistant to the treatment.
The CDC’s Mermin said the agency will roll out pilot programs in four cities - Chicago, Philadelphia, Houston and Newark, New Jersey - that have federally qualified health centers in areas with high HIV rates.
“It is not a magic pill,” said Princy Kumar, professor of medicine and microbiology at Georgetown University and chief of infectious diseases at MedStar Georgetown University Hospital in Washington.
“It’s one more intervention that’s shown to work,” she said. “And it works well provided that it is taken every day” and in conjunction with safe sex practices, consistent counseling, and with the population at high risk of contracting the disease. Because the drug has to be taken each day for years and years, it can be difficult to administer, she said.
Kumar said the most significant side effects of the drug are weakness of bones in healthy people over a period of time, and renal issues in people with underlying ailments including diabetes or hypertension.
A number of physicians are hesitant to prescribe the medicine as a preventative because of associated risks, according to a December study by the National AIDS Manual.
“There’s potential to adverse effects with any medication,” Mermin said. “The two drugs that are used in PrEP are very safe medicines. Most people have no side effects even after taking it daily for year,” according to studies that informed the CDC’s recommendation.
“PrEP has the potential to alter the course of the epidemic,” he said. “Having these guidelines come out now will hopefully prevent thousands of people from getting and spreading a potentially fatal disease.”
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