Preventing HIV: New Tools, New Hope
Since Truvada is already available by prescription, the CDC and other public health agencies are developing guidelines on its use as PrEP. Without this guidance, unsafe and ineffective use may occur. Among these concerns are the use of other HIV meds not used in the study and not proven safe for HIV-negative people; using a dosing schedule not proven effective (such as just before sex or only after sex); not screening for HIV before starting PrEP or waiting long periods of time before retesting for HIV; and providing prescriptions for PrEP without other HIV prevention support, such as condoms and risk-reduction counseling.
Additionally, reports suggest that some people are already using HIV meds not prescribed to them, following unapproved PrEP regimens. Studies of how they get the meds, and from whom, may help to eliminate a black market that could undermine any benefits of PrEP. A critical concern is that people who sell their HIV meds will miss their own doses, leading to drug resistance. This puts their health at risk and could increase community viral load.
The New York State AIDS Institute is currently seeking advice from an advisory group of clinicians to determine next steps, but it will take several months before guidelines are published. The AI is urging providers and patients to wait for guidelines to be released before using PrEP. The CDC recently released interim guidelines for use of PrEP for MSM. The guidelines specifically discourage anyone other than high-risk, HIV-negative MSM from using it (since there are no data in other groups), and instruct users to follow the regimen used in the iPrEx study. This includes daily dosing of Truvada, regular HIV testing, treatment of other STIs, and risk-reduction counseling and condoms. The interim guidelines also provide information on how best to discontinue PrEP.
The retail price of Truvada is $14,000 a year in the U.S., and even though insurers and Medicaid pay less than that, the price to them is still in the thousands. If it is approved for PrEP, some have asked how a "chemical condom" that costs $38 a day could be justified when condoms themselves cost a few cents each. In the U.S., we would need cost-effectiveness analyses, perhaps calculating the cost of PrEP per infection avoided, to convince insurers and Medicaid that it is worth the money.
In developing countries, where generic forms of Truvada are available for as low as $143 a year, the picture is very different. If PrEP is approved in these countries, the biggest dilemma may center on providing HIV drugs for prevention when only 36% of people with HIV have access to these same drugs to save their lives. This lack of access to treatment makes justifying funding for PrEP challenging. Treatment alone, however, is not enough to stop the epidemic. With 56,000 new HIV infections in the U.S. and 2.7 million new infections worldwide, it is imperative that we utilize every prevention option available.
The Way Forward
Education about these two prevention methods will most likely be centered in health care facilities. This will require that they have enough personnel and supplies to provide high-quality services that are available to the most vulnerable people. And before these new methods are widely used, the general community, and people with HIV, must be educated about them. Education needs to be correct, easily available, and constantly updated about new prevention methods. Both microbicides and PrEP are still in the development phase, and each new result will bring both new information and new questions.
Samuel Kalibala is a Senior Associate and Country Director (Kenya) at the Population Council. Sarah Littlefield is a Clinical Trial Specialist in the HIV/AIDS Program at the Population Council. Robert Valadéz is a Policy Analyst at GMHC.
Prevalence and Correlates of Heterosexual Anal Intercourse Among Clients Attending Public STD Clinics in Los Angeles County
This article was provided by ACRIA and GMHC. It is a part of the publication Achieve. Visit ACRIA's website and GMHC's website to find out more about their activities, publications and services.
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