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 ||||| Each morning, I take a pill called Truvada to protect me from becoming infected with HIV. This strategy, also known as pre-exposure prophylaxis, or PrEP, reduces the risk of HIV infection by up to 99 percent if the pill is taken once a day. This makes PrEP one of the most effective HIV-prevention measures in existence. After consulting with my physician, I went on PrEP to further protect and take personal responsibility for my health. I'm HIV-negative, and I want to remain that way. 
 
 I recently decided to be public about my use of PrEP in order to raise awareness about this relatively new tool for preventing HIV. It's important to encourage people at risk for HIV to talk to their medical providers about all the tools and methods available for preventing infection, including PrEP, and to choose the methods that are best for them. 
 
 As an elected official, disclosing this personal health decision was a hard but necessary choice. After all these years, we still see enormous stigma, shame, and judgment around HIV, and around sexuality in general. That is precisely why I decided to be public about my choice: to contribute to a larger dialogue about our community's health. I have the honor of representing a district that includes the Castro -- ground zero for the HIV epidemic. I represent a community that has been profoundly impacted by HIV, with a large number of HIV-positive people -- nearly one in four gay men in San Francisco is HIV-positive -- and an even larger number of people at risk of becoming positive. As an elected official in this role, I have an obligation to do everything in my power to support those living with HIV, increase public awareness about effective HIV prevention, and reduce stigma and shame. 
 
 My journey to PrEP was a long one. I came to terms with myself as a gay man when I was 17 years old in 1987, at the height of the HIV epidemic. Many gay men were getting sick and dying. Like many in my generation, I came of age associating sex with illness and death. That association -- with all the fear, anxiety, guilt, and shame that go along with it -- is still very real for many of us. 
 
 As time has gone by, I've seen people become healthier, and I'm continually in awe of those who have survived the epidemic and thrived. Yet new HIV infections continue -- 50,000 annually in the U.S., and over 2 million annually worldwide. Despite all our prevention efforts, I continue to know people who've remained HIV-negative for 20 or 30 years, only to become HIV-positive. I regularly meet young men, some barely out of high school, who have the virus. 
 
 None of this is preordained. People don't need to continue to get infected, and we know that PrEP has the potential to help stop the epidemic in its tracks by ending new HIV infections. It's one pill a day, with few side effects for most people. 
 
 Condoms remain critically important for HIV-prevention efforts, but they have their limits, as demonstrated by the continuing new infections after 30 years of robust prevention efforts. Only one in six gay men uses condoms consistently and effectively enough to be fully protected from HIV. For those who do use them consistently, condoms offer significant protection but have a failure rate, and condom usage among gay men reduces HIV risk by 76 percent, not 100 percent. 
 
 Given the challenges many gay men have with consistent condom use as well as the continued risk of HIV transmission even for those who use condoms, PrEP provides a powerful additional level of protection. It's not a question of either condoms or PrEP. It's about both important tools. 
 
 PrEP has broad support in the public-health community. The World Health Organization and Centers for Disease Control and Prevention have recommended its use by those at risk for HIV, including gay men. The state of New York and the San Francisco Department of Public Health have adopted PrEP as a core prevention strategy. The HIV advocacy community overwhelmingly supports PrEP. Most insurance companies cover it fully despite its considerable cost, precisely because it is so effective at preventing a serious illness for which there is no cure. 
 
 Some aren't sold on PrEP. Skeptics question whether people will adhere to a daily pill, which is a legitimate concern. Protection decreases if usage is inconsistent. This challenge can be overcome with effective education, and drug adherence is a challenge that isn't unique to PrEP. 
 
 Some critics also view PrEP as a license for people to engage in risky behavior and assert that it will cause non-HIV sexually transmitted infections to increase. No study to date has shown that those using PrEP increase risky behavior -- such as reducing condom usage compared with before using PrEP -- and there is evidence to the contrary. Indeed, this line of thinking -- that promoting an effective prevention method will lead to irresponsible behavior -- resembles some of the phony arguments used to attack the HPV vaccine by suggesting that getting vaccinated will lead young girls down a path to promiscuity. And, since PrEP users are regularly screened for HIV and other sexually transmitted infections, PrEP use will increase opportunities for prompt detection and treatment of STIs. 
 
 PrEP isn't only about gay men. Women can benefit tremendously from it as well. Many women are using PrEP to conceive a child with an HIV-positive partner, a new approach dubbed "PrEP-ception." PrEP can also protect women (and men) in abusive relationships. Too many women -- and gay men as well -- don't fully control how or when they have sex, whether their partners use condoms, and what risks their partners are taking elsewhere. People facing these challenges can take control of their infection risk -- and essentially eliminate that risk -- by using PrEP effectively. 
 
 In addition to lack of education and stigma, another significant barrier to fully realizing PrEP's potential benefits is lack of access. PrEP isn't cheap, and for the many people who are uninsured or underinsured, cost can effectively deny access. PrEP needs to be easily available to all communities and all income levels through public healthcare programs, including Medicaid. Otherwise we risk accentuating health disparities among our diverse communities. 
 
 Many people and organizations have gotten us where we are with PrEP. The University of California San Francisco is responsible for some of the earliest clinical studies of PrEP, and organizations like San Francisco AIDS Foundation, Project Inform, and the AIDS Vaccine Advocacy Coalition have been working on the front lines to ensure that the promise of PrEP is fully realized, including advocating for FDA approval, helping establish expanded access programs from the drug manufacturer, ensuring PrEP is covered by insurance plans, and disseminating information to consumers and clinicians. 
 
 We know how to end HIV infection. We simply need the political will to ensure that the community has accurate information about and access to all prevention methods, including PrEP. I hope my disclosure can play a role in moving us toward these goals. 
 
 Scott Wiener is an elected member of the San Francisco Board of Supervisors. For more information, visit scottwiener.com.
– 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."