HIV-preventing drug holds up under study 
 
 Truvada, a daily pill that holds the hope of eliminating the risk of contracting HIV, appears to be living up to its promise. 
 
 In the first real-world study of the prescription drug, Kaiser researchers found no new HIV infections among the more than 650 people they followed over nearly three years, beginning just after the drug was approved by the U.S. Food and Drug Administration in 2012. 
 
 A clinical trial leading up to the FDA approval had shown that Truvada, made by Foster City’s Gilead Sciences, nearly eliminated the risk of getting infected by the AIDS virus. But no evaluations of the drug, also known as PrEP, for pre-exposure prophylaxis, had been published outside the tightly regulated clinical trial setting. 
 
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 In the new study, participants were sexually active. Many did not use condoms for prevention, and half of them were diagnosed with other sexually transmitted diseases within a year of starting the study. But no new HIV infections turned up, researchers said. 
 
 “This is really compelling data that shows that PrEP works in a real-world setting,” said Dr. Jonathan Volk, a San Francisco Kaiser physician and epidemiologist and lead author of the study, which was published Wednesday in the medical journal Clinical Infectious Diseases. 
 
 Truvada, which contains the antiviral drugs emtricitabine and tenofovir, was originally created as an anti-retroviral drug used to treat HIV, but it has been shown to reduce the risk of HIV infection in people who are at high risk by up to 92 percent when taken consistently, according to the U.S. Centers for Disease Control and Prevention. 
 
 Drug has its critics 
 
 Still, the drug, which costs Kaiser patients about $50 a month, is not without controversy. PrEP was criticized early on by health providers and other advocates over concerns that the drug would encourage unsafe sex because of a false sense of security. In fact, the Kaiser study did find a significant decrease in condom use among the participants. 
 
 One of the loudest critics has been Michael Weinstein, president of the AIDS Healthcare Foundation in Los Angeles, who has publicly called Truvada a “party drug.” While PrEP may be an option for high-risk individuals who don’t use condoms, he said last month, it should not be used as community-wide public health intervention strategy. 
 
 But the CDC and public health advocates disagree. 
 
 The CDC last summer recommended the drug as a prophylactic for those at highest risk of becoming infected — sex workers, men with HIV-positive partners or those who engage in high-risk behaviors, such as IV drug use — and under careful watch by their doctors. San Francisco health advocates have also recognized Truvada as an important tool for the city’s Getting to Zero program, which aims to make the city the first in the country to have no new HIV infections, deaths or stigma. 
 
 “We have a fantastic new tool we can be using to help our patients protect themselves from HIV,” Kaiser’s Volk said. “I don’t think PrEP is right for everybody. But for the folks who need it, it works.” 
 
 No new infections seen 
 
 To test the effectiveness of the drug, Kaiser researchers identified 657 Kaiser San Francisco patients and followed them over 32 months without requiring anything after their initial screening other than regular testing for sexually transmitted diseases and completing an occasional questionnaire. The average age was 37, and 99 percent were men who have sex with men. 
 
 The study did not have a control group for the sake of comparison, but the participants clearly weren’t abstinent. After six months, about 30 percent of the PrEP users had been diagnosed with at least one sexually transmitted infection, with that number rising to 50 percent after a year. But there were no HIV infections, the study found. 
 
 When the participants were asked about any changes in behavior, 74 percent reported no change in their number of sexual partners, while 15 percent reported a decrease and 11 percent said the number increased. Condom use was unchanged in 51 percent of the participants, while 41 percent said they had decreased their condom use and 3 percent had increased the use of condoms. 
 
 “We know adherence to the medication is a really importance piece,” Volk said. “The fact we had no new HIV infections is very encouraging, but we still have more to learn about how people are using this medication.” 
 
 ‘At high-risk phases’ 
 
 For study participant Paul Marcelin, a San Francisco Kaiser patient who lives in Alameda, the drug allows him to protect himself while maintaining his relationship with his HIV-positive boyfriend. “I felt very comfortable that we don’t worry the same way that some couples might,” he said. 
 
 Marcelin, 40, a database expert, participated in a separate PrEP study conducted in 2013 by the San Francisco Department of Public Health and stayed on the drug for the Kaiser study. He said he thinks any hesitancy about Truvada is starting to dissipate, and people are accepting it as another prevention option. 
 
 “PrEP is something you can choose to use when at high-risk phases in your life,” he said. “I’m in a phase of my life I need to use it, but I won’t always be.” 
 
 Victoria Colliver is a San Francisco Chronicle staff writer. E-mail: vcolliver@sfchronicle.com Twitter: @vcolliver ||||| Bloomberg News 
 
 Healthy people at risk of HIV are advised to take daily pills that cut the odds of infection by more than 90 percent, U.S. health officials said in the first formal recommendation on using the drugs as a preventative. 
 
 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 in a statement. Gilead Sciences Inc. (GILD:US)’s 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 aren’t 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. 
 
 The strategy of using the pills, call 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 Food and Drug Administration in 2012 to be used as a prevention regime with safe sex practices and regular HIV testing. 
 
 ‘Life-Saving Tool’ 
 
 “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 wants its new guidelines to help promote mass distribution of the HIV medicine. The agency is working with other health organizations 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,” Cara Miller, a Gilead spokeswoman, said in an e-mail. The company also assists patient who need the medicine but aren’t covered by insurance, she said. 
 
 Cost Factor 
 
 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 nonprofit group 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 also is a concern that patients won’t take the drug as directed, the group said in a statement. 
 
 “This is a position I fear the CDC will come to regret,” AFP president Michael Weinstein said in the statement. 
 
 ‘Catastrophic Consequences’ 
 
 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,” Weinstein 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. 
 
 Taken Daily 
 
 “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.” 
 
 To contact the reporter on this story: Sonali Basak in New York at sbasak7@bloomberg.net 
 
 To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Andrew Pollack, Bruce Rule ||||| Federal health officials recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take a daily pill that has been shown to prevent infection with the virus that causes it. 
 
 If broadly followed, the advice could transform AIDS prevention in the United States — from reliance on condoms, which are effective but unpopular with many men, to a regimen that relies on an antiretroviral drug. 
 
 It would mean a 50-fold increase in the number of prescriptions for the drug, Truvada — to 500,000 a year from fewer than 10,000. The drug costs $13,000 a year, and most insurers already cover it. 
 
 The guidelines tell doctors to consider the drug regimen, called PrEP, for pre-exposure prophylaxis, for gay men who have sex without condoms; heterosexuals with high-risk partners such as drug injectors or male bisexuals who have unprotected sex; patients who regularly have sex with anyone they know is infected; and anyone who shares needles or injects drugs. 
 
 Officials at the Centers for Disease Control and Prevention have long been frustrated that the number of H.I.V. infections in the United States has barely changed in a decade, stubbornly holding at 50,000 a year, despite 30 years of official advice to rely on condoms to block transmission. 
 
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 Although there is no guarantee that gay men will adopt the drug regimen, federal officials say something must be done because condom use is going down. In a C.D.C. survey in November, the number of gay men reporting recent unprotected sex rose nearly 20 percent from 2005 to 2011. 
 
 Nevertheless, advocates for the drug regimen were elated at Wednesday’s announcement. 
 
 “This is wonderful,” said Damon L. Jacobs, a therapist in Manhattan who is HIV negative, has been on the regimen since 2011 and runs a Facebook page promoting it. “When an institution like the C.D.C. makes a statement, it makes a profound difference to the doctors who are ambivalent.” 
 
 Dr. Jonathan Mermin, director of the C.D.C.’s national center for AIDS and other sexually transmitted diseases, said the new guidelines should save many lives. 
 
 “On average, it takes a decade for a scientific breakthrough to be adopted,” he said. “We hope we can shorten that time frame and increase people’s survival.” 
 
 While many antiretroviral drugs could in theory be used for the drug regimen, the only pill approved for that purpose by the Food and Drug Administration is Truvada, made by Gilead Sciences. 
 
 Truvada, a mix of tenofovir and emtricitabine, is considered relatively safe with few side effects. Generic versions are made in India, and it has become the backbone of AIDS treatment in poor countries. 
 
 Common side effects include headache, stomach pain and weight loss. Rare but serious ones include liver and kidney damage. 
 
 Officially, the C.D.C. is endorsing the drug regimen only in conjunction with condoms. But health officials say they know that some people will stop using them. Many gay men, including Mr. Jacobs, report doing just that. 
 
 That raises their risk of contracting other diseases, like syphilis and gonorrhea. But health officials argue that the benefits of taking the drug regimen outweigh the risks. 
 
 Continue reading the main story Ask Well Do you have a question about Truvada? Or the new recommendation that all Americans at high risk for H.I.V. take this drug? Your question may be answered by our reporter, Donald G. McNeil, Jr. All open questions » 
 
 “Making the perfect the enemy of the good is something we’ve got to get over,” said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases and the country’s best-known AIDS doctor. “I strongly support the C.D.C. doing this.” 
 
 Continue reading the main story Advertisement 
 
 Syphilis and gonorrhea can usually be cured with antibiotics, but H.I.V. lasts for life and is fatal if left untreated. Even those treated properly often develop early heart disease and other problems. 
 
 Since 2010, three separate studies using Truvada have shown that when taken daily it can vastly reduce the chances of infection. That held true for gay men, heterosexual couples and drug injectors. In the study of gay men, known as iPrEx, men whose blood tests showed they had taken their pill every day were 99 percent protected. 
 
 The new guidelines say patients should have an H.I.V. test before starting the regimen, to make sure they are not already infected. (Prophylaxis involves doses of two drugs, but anyone with the disease should be on triple therapy.) 
 
 Patients should be retested every three months to be sure that they are still H.I.V. negative, that they are not developing side effects from the drug and that they have not caught any other sexually transmitted diseases. 
 
 While many AIDS specialists endorse the drug regimen, it has not caught on among doctors as a whole. 
 
 A survey of 1,175 infectious disease specialists in the United States and Canada published in December showed that 74 percent supported it, but only 9 percent had actually prescribed it. 
 
 “There’s a lot of inertia among doctors, and a strong statement from the C.D.C. will be pretty valuable for overcoming that,” said Dr. Demetre C. Daskalakis, an AIDS specialist at Mount Sinai Hospital in New York who has many patients on the regimen. 
 
 Also, the drug regimen has not caught on among gay men, who are by far the largest risk group. 
 
 By analyzing pharmacy databases, Gilead has tried to track how many Truvada prescriptions are for the drug regimen, rather than AIDS treatment. As of last September, the company said, it knew of only 2,319 — of which 49 percent were for women. 
 
 Continue reading the main story To Save a Life Scientists have compared the effectiveness of two preventive drug regimens: a daily dose of Truvada, against H.I.V.; and statins to prevent heart attacks. By that measurement (called “number needed to treat”), the Truvada regimen is far more likely to save lives. 250 Number of people taking statins for one year to prevent one heart attack. 61 Average number of people given Truvada for one year to prevent one H.I.V. infection. 
 
 Advocates said there were several reasons there had been little clamor for the drug regimen. First, while many doctors prescribe statins as prophylaxis against heart attacks, for example, only AIDS specialists are likely to prescribe AIDS drugs as prophylaxis. But uninfected gay men have no reason to see AIDS specialists, and usually see general practitioners if they see doctors at all. 
 
 Also, Truvada is expensive. However, private insurers and state Medicaid programs have thus far generally covered such prescriptions, and Gilead has a program covering co-pays and giving Truvada to the uninsured. 
 
 “In my experience, it’s a simple process to get the meds approved,” Dr. Daskalakis said. 
 
 Another reason is that Gilead does not advertise Truvada for prophylaxis, even though the F.D.A. approved it for that use in 2012 and Gilead does advertise it for treatment, for which it was approved in 2004. 
 
 A company spokeswoman said it had no plans to do so, but it does make grants to gay organizations that espouse the drug regimen. 
 
 Not advertising helps Gilead avoid controversy. 
 
 Michael Weinstein, president of the AIDS Healthcare Foundation, has called Truvada a “party drug” and argued that the drug regimen would encourage men to avoid condoms and thus increase the infection rate. He called the release of the guidelines “a shameful chapter in the history of the C.D.C.” 
 
 That debate has played out on gay websites, where men favoring the drug regimen are often stigmatized as “Truvada whores.” (The term was coined in a 2012 Huffington Post article whose author has since publicly regretted his stance.) 
 
 “People are reacting out of fear,” Mr. Jacobs said. “Gay men who embraced the condom message and survived the trauma of 30 years ago have PTSD. This is a paradigm shift, and people don’t like change.” 
 
 Recently, a lash against the backlash has emerged, with a few men proudly wearing “Truvada Whore” T-shirts, just as others proudly wear “Queer” or “H.I.V. Positive” ones. 
 
 Adam Zeboski, a test counselor for the San Francisco AIDS Foundation, makes and sells “Truvada Whore” T-shirts to raise money for the foundation. 
 
 “People are both very supportive and very offended,” he said. “By reclaiming the ‘Truvada Whore’ term, we’re taking the power away from those who use it against us.”
– Big news in the fight against HIV: Kaiser Permanente, San Francisco's biggest private insurer, says that over a 32-month period, not a single one of its clients taking Truvada contracted HIV. Truvada is the name of the daily pre-exposure prophylaxis, or PrEP, pill that the CDC recommended for use in at-risk populations earlier this year. The new study followed 657 San Franciscans (all but four of them gay men) who asked their doctors for Truvada, and found that while condom use did decline—a major fear of PrEP critics—no one contracted HIV between mid-2012 and February of this year, the New York Times reports. More than 40% of the subjects said they used fewer condoms after starting Truvada, the San Francisco Chronicle reports, and while half of the subjects got syphilis, gonorrhea, or chlamydia within a year of starting PrEP, the Times notes most sexual infections other than HIV can be cured with antibiotics. And rates of those infections were already climbing among gay men before PrEP came on the market, a doctor notes. This was an observational study of the $50-a-month drug; a clinical trial last year actually gave some participants a placebo instead of Truvada. That study, however, was stopped early—because it became so obvious that Truvada worked that it was unethical to keep some of the subjects on a placebo. This new study "takes it out of the realm of clinical trials and into the real world," one doctor and infectious disease expert says. An AIDS activist echoes that, noting the study "fills in a critical gap by showing that PrEP can prevent infections in a real-world public health program." "This is very reassuring data," adds the lead author of the new study. "It tells us that PrEP works even in a high-risk population." According to ABC 7, the study population also included "injection drug users."