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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)

CME Content


Evolocumab (Repatha), a human monoclonal antibody and proprotein convertase subtilisin/kexin type 9 inhibitor, produced positive results in persons living with HIV in the BEIJERINCK study by reducing their levels of low-density lipoprotein cholesterol (LDL-C). These individuals have a risk of cardiovascular disease that is almost twice that of HIV-negative individuals.

The environment surrounding the coronavirus disease 2019 (COVID-19) pandemic seems to change by the minute. The full extent to which HIV-positive individuals can be affected if they contract COVID-19, because they are immunocompromised, is not known. Recently, the CDC issued guidance for this patient population.

Between 2010 and 2017, there were 327,700 new HIV infections in the United States. Of these, HIV-2 infections accounted for less than 0.03% of the total. It is important to differentiate which HIV strain an individual is infected with because HIV-2 is intrinsically resistant to nonnucleoside reverse-transcriptase inhibitors, which are typically used to treat HIV-1 infections.

A second individual may have been cured of HIV following an allogeneic stem-cell transplant for stage 4b refractory Hodgkin lymphoma with Δ32-mutated cells, which are resistant to the virus. These cells did not express the CCR5 chemokine receptor, 1 of 2 methods of entry for HIV into a host cell.

A year after being only the second person to be cured of HIV, the “London Patient” revealed his identity; BMS announced today that its combination therapy for multiple myeloma—elotuzumab, lenalidomide, and dexamethasone—failed its primary endpoint of progression-free survival in its phase 3 ELOQUENT-1 trial; Biocon and Mylan N.V. announced that the FDA accepted their biologics license application (BLA) for MYL-14020, a proposed biosimilar to bevacizumab (Avastin), for review.

In 2018, Washington, DC, saw 340 newly diagnosed cases of HIV, according to a study published in Scientific Reports. The city’s rate is 5 times higher than the national rate, and it falls under the World Health Organization’s definition of an epidemic. Researchers used next-generation sequencing to gain a broader view of the disease’s dynamics in the DC area.

Chronic obstructive pulmonary disease (COPD) occurs at a higher rate in individuals who have HIV compared with those who do not, and it has a global incidence of more than 380 million people. The progressive lung disease is also diagnosed at a younger age in HIV-positive persons compared with their HIV-negative counterparts, and higher rates of smoking may be to blame.

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.

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