The latest study results of Truvada, the drug used for PrEP, or pre-exposure prophylaxis, found that not a single person became infected with HIV. The Kaiser study followed more than 650 people beginning in 2012 when the U.S. Food and Drug administration approved Truvada. The Kaiser study is the most definitive yet that a once-a-day pill can prevent HIV if taken as prescribed, and it validates previous clinical trials that also showed remarkable promise for the drug (HIV infection was reduced for people who are high risk by 92 percent when they took the medication as directed).
That's good news as federal, state, and local entities work to ramp up PrEP use, especially among gay and bisexual men. Expanded access to PrEP, via Truvada (tenofovir and emtricitabine), is a cornerstone of San Francisco's Getting to Zero coalition, which aims to dramatically reduce HIV transmission by 90 percent by 2020. The ultimate goal is no HIV infections.
An important aspect of the Kaiser study is that it's the first one to follow people on PrEP in real-world settings, without the regulations of a clinical trial. Participants in the study were sexually active. Many did not use condoms, and half were diagnosed with other sexually transmitted diseases. Researchers found no new HIV infections.
There's never been much to debate about Truvada for PrEP. But one agency, the Los Angeles-based AIDS Healthcare Foundation, has waged a lonely battle against the drug, cherry-picking research results, and fear-mongering to sway the LGBT community. In fact, it was just over a year ago that AHF launched a full-scale assault on PrEP, running misleading ads in this newspaper and elsewhere claiming that the clinical trial PrEP results weren't as good as were claimed. But it's been a long 12 months for AHF and its outspoken president, Michael Weinstein. With this latest Kaiser "real-world" study confirming previous results, AHF has retooled its message, and that's a good thing.
In its latest ad, which ran in the Bay Area Reporter , AHF is "Reaching for Common Ground on PrEP." The agency now has principles it's offering "for the administration of PrEP for the community's consideration." Those include PrEP for those who have not and will not use condoms; testing and re-testing for STDs for those taking PrEP; and urging those considering PrEP to thoroughly discuss the issue with their medical provider. AHF also urges people who are on PrEP to take the drug every day. That's important because adherence to the medication regimen is key.
AHF also offers some advice that's worth repeating: medical providers need to engage in "frank conversations" about sexual risks with patients. We would add general sexual health, too. We still hear too many stories about LGBT people who have reservations about candid conversations with their doctors, or worse, physicians who don't "get it" when patients reveal that they are LGBT. This underscores the need for regular training of medical professionals on LGBT health issues.
Access to PrEP is a crucial component, not only for San Francisco's Getting to Zero program, but for the success of PrEP worldwide. The costs must come down, insurers must include it in covered prescriptions, and it needs to be widely available in developing countries in Africa and Central and South America. AHF stated in its principles that "more study is needed, particularly among marginalized populations such as women, youth, African-Americans, and Latinos about the likelihood of adherence to PrEP." We think such studies can be conducted in real-world environments similar to the Kaiser research. That way, patients would have access to the drug and follow-up counseling to help them succeed. We suspect that adherence to the regimen won't be a problem. What will be challenging is making sure people who are in lower income brackets, which historically in this country includes minorities, are able to afford PrEP, or receive a subsidy or patient assistance plan to get it.
AHF still doesn't seem convinced that PrEP is a major new tool in the fight against HIV. But with its latest ad campaign calling for a truce, it's clear that AHF's tired of fighting a losing battle.