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Clarifying USPSTF Recommendations for HIV Pre-Exposure Prophylaxis (PrEP)

This discussion focuses on how to address barriers and disparities as obstacles to using PrEP, with a focus on USPSTF PrEP guidelines and ACA Part 47 for payers and providers.

Clarifying USPSTF Recommendations for HIV Pre-Exposure Prophylaxis (PrEP)


The Patent Trial and Appeals Board delivered a setback to Gilead Sciences, rejecting its attempt to invalidate a pair of Truvada patents owned by the CDC; Merck is spinning off some businesses in order to focus on its oncology drug pembrolizumab, including its biosimilars operations; Republican and Democratic governors are worried that a proposed CMS fiscal accountability rule for Medicaid will reduce access to healthcare.

The FDA launched a mobile-friendly, interactive database providing information on eligible HIV antiretroviral treatments available; an HIV vaccine trial by Fred Hutchinson Cancer Research Center ended after failing to provide protection from the virus; New Jersey Governor Phil Murphy established a coronavirus task force to manage the state’s preparedness and response to the virus.

Antiretroviral treatment (ART) is the regimen mainstay for everyone who has HIV, irrespective of infection duration. More than twice as many options for ART were available in 2018 as were offered in 2012—but this did not equal cheaper prices. Between 2012 and 2018, the average wholesale price for initial ART jumped 34% for most people with HIV.

Participants in Last Gift, an end-of-life HIV research program from UC San Diego, donate their blood and their bodies so researchers can uncover all the places that HIV hides, to both fight the disease and stop it. Before each autopsy, the following is read: “From our first breath to our last, each of us tells a unique story. Here, we honor our Last Gift participants for their altruism to further research into HIV and the human condition. We take this moment of silence to honor their gifts and express our gratitude for all the discoveries their selfless donations will yield.”

New York Attorney General Letitia James announced a lawsuit filed against 2 former chief executive officers of Turing Pharmaceuticals, now known as Vyera Pharmaceuticals: “Pharma Bro” Martin Shkreli, currently serving a 7-year sentence in federal prison for securities fraud, a crime that took place before the launch of Vyera, and his business partner Kevin Mulleady.

The use of antiretroviral therapy has allowed patients with HIV to have a life expectancy that approaches the lifespan of those without HIV. Despite this progress, however, HIV-associated neurocognitive disorders remain prevalent, and range from mild problems with memory, language, and reasoning to more severe HIV-associated dementia.

A second study, slated for next year, will continue these infants on antiretroviral treatment with 2 experimental monoclonal antibodies, hoping the medications produce viral suppression—and testing the effects of temporarily stopping them—so that they don’t have to eventually initiate the standard triplet therapy that most older patients typically take. For adults, most treatments for HIV come from the cancer field, and are inflammatory, and are not safe enough to apply in children. An ongoing debate is when is it appropriate to begin these therapies in children.

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