October 6, 2017
This week, we learn about new data exploring the critical intersection between HIV treatment access and reduced HIV incidence in the U.S. We also ponder the value of replacing placebos with pre-exposure prophylaxis (PrEP) in clinical trials on HIV prevention; the wisdom of prescribing PrEP to women with bacterial vaginosis; and the cost-effectiveness of routine HIV screening in primary care settings.
To beat HIV, you have to follow the science!
More than 250,000 seroconversions could be avoided in the U.S. over the next 20 years, if the National HIV/AIDS Strategy goal of having 72% of people living with HIV virally suppressed by 2020 were achieved, a mathematical model published in The Journal of Infectious Diseases showed. This number of seroconversions includes 80,000 African-American men who have sex with men, a group that currently faces a 50% lifetime risk of seroconversion.
Such a scale-up of HIV prevention and treatment efforts would require a 5% annual increase in federal HIV spending, unless the cost of antiretroviral medications dropped significantly, researchers estimated.
Studies have shown the importance of health insurance for HIV treatment access, Adaora A. Adimora, M.D., M.P.H., noted in a related editorial. The Affordable Care Act and its provision for expanded Medicaid coverage dramatically increased the number of people with such insurance. "Of all the threats to progress in controlling the U.S. HIV epidemic, however, the constant assault on the ACA and expansion of healthcare access is potentially the most damaging," she concluded.
New biomedical agents for HIV prevention should be compared to tenofovir disoproxil fumarate/emtricitabine (Truvada), the proven PrEP medication, rather than a placebo, Treatment Action Group recommended in a report on HIV prevention research released on Sept. 27.
The report notes that two current clinical trials involving experimental biomedical agents for HIV prevention use a "double-dummy" approach, where participants in one arm receive the study drug plus placebo Truvada, and in the other arm participants get Truvada plus study drug placebo. However, other trials refer participants to outside PrEP sources.
Report authors argued that either referrals or direct provision of PrEP should be standard in all prevention trials, unless researchers can argue convincingly why this should not be the case. PrEP may also enhance the effectiveness of experimental HIV vaccines, they suggested.
Almost half of respondents to TAG's survey on prevention research favored direct PrEP services during a clinical trial; by comparison, almost a quarter argued for providing Truvada by referring participants to outside sources for related services.
The report also recommended seeking community input and following good participatory practices during trial design.
Oral PrEP worked similarly well in women with bacterial vaginosis and in those with healthy vaginal microbiota, an analysis published in The Lancet HIV showed.
The CAPRISA trial of topical tenofovir for PrEP had found that the gel was less efficacious in women with vaginal dysbiosis. For the current analysis, researchers used data on almost 1,500 women enrolled in the Partners PrEP study, close to a quarter of whom had bacterial vaginosis. Partners PrEP assessed the efficacy of daily tenofovir disoproxil fumarate or tenofovir disoproxil fumarate/emtricitabine (Truvada) to prevent seroconversion among East African serodiscordant couples. The trial's placebo arm was stopped early when the PrEP arms showed two-thirds or better efficacy, but the data analyzed here were collected prior to that.
Oral prophylaxis is being rolled out among young women in areas where both HIV and bacterial vaginosis are common. "Our results suggest that, in the setting of high adherence to PrEP, women with vaginal dysbiosis receive the same high level of protection as women with healthy microbiota," study authors concluded.
HIV testing during primary care is cost-effective in the United Kingdom in areas with high HIV prevalence, a model published in The Lancet HIV found.
The analysis was based on data from a clinical trial that assessed the integration of rapid opt-out HIV testing into standard health checks in a high prevalence London neighborhood. The cost of such screenings and resulting early antiretroviral therapy was compared to the expense of treating people who are diagnosed with advanced symptoms in addition to the cost of treating onward transmissions of the virus. After 33 years, the model determined that the money saved from avoiding late treatment and additional seroconversions makes testing and earlier treatment a cost-effective intervention at an incremental cost-effectiveness ratio of £30,000 per quality-adjusted life year gained.
Researchers noted that this threshold would be reached much sooner in countries with higher long-term health care costs for people diagnosed late, such as in Canada. The intervention might even produce cost savings, they suggested, in places where health care costs remained more expensive for patients diagnosed late than for patients diagnosed early.
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