Research Spotlight: Generic daily HIV prevention pill for young men who have sex with men could save lives and money

Anne Neilan, MD, a physician-scientist in the division of Infectious Diseases at Massachusetts General Hospital is the senior author of a recently published paper in Clinical Infectious Diseases, Daily Oral HIV Pre-exposure Prophylaxis Among Young Men Who Have Sex With Men in the United States: Cost-Saving at Generic Drug Price.

Summary: Compared to annual HIV screening alone, generic daily oral HIV pre-exposure prophylaxis (PrEP) with HIV screening every three months would result in fewer HIV acquisitions, longer life expectancy, and fewer HIV-associated costs among young men who have sex with men in the United States. These projections which come from a simulation modeling study supported by the National Institutes of Health, illustrate the value of promoting PrEP use in this population.

What was the question you set out to answer with this study?

About one in five new HIV diagnoses in the United States occur among youth ages 13 to 24 years. Young men who have sex with men (YMSM) are account for 81% of new diagnoses in this age group in 2019. When taken daily as prescribed, oral PrEP reduces the risk of sexually acquiring HIV by about 99%. Compared to older men who have sex with men, YMSM are less likely to start PrEP and tend to have more challenges adhering to PrEP and remaining in care.

Our team wanted to understand how tenofovir-based daily oral HIV pre-exposure prophylaxis (PrEP) would compare to current CDC-recommended annual HIV screening in terms of clinical benefits and costs among U.S.-based YMSM in light of newly available generic PrEP medication and new CDC guidelines for PrEP use.

What Methods or Approach Did You Use?

Our research team used data from two studies conducted by NICHD’s Adolescent Medicine Trials Network for HIV Interventions. These studies examined the acceptability and feasibility of daily TDF-FTC among young men ages 15 to 22 years considered at increased risk of acquiring HIV because they engaged in condomless anal sex or had other sexually transmitted infections (STIs).

What Did You Find?

The model projected that over 10 years, the generic PrEP strategy would reduce new HIV acquisitions from 37% to 30% and decrease costs by $5,000 per person, compared to annual screening.

The finding that PrEP would provide more benefits at lower cost held up across several scenarios, including a range of ART prices, HIV incidence rates, and PrEP retention rates.

Even if as few as 6% of young men remained in the PrEP program after six years, the strategy would still have benefits over annual screening.

Our team also found that offering generic PrEP in addition to screening every three months was more cost-saving than every-three-month screening alone.

What are the Clinical Implications?

Our findings show us that we would be throwing away both lives and money by failing to implement generic PrEP in this population. Policies that create barriers to PrEP access for this population – such as the recent Braidwood Management versus Becerra case, which overrules ACA-mandated employer-based coverage for HIV PrEP – aren’t justifiable on clinical or economic grounds.

What are the Next Steps?

Our research team’s next step is to understand the value interventions to improve access to and adherence to existing and novel HIV prevention strategies in adolescents and young adults in the US and abroad.

About the Massachusetts General Hospital

Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The Mass General Research Institute conducts the largest hospital-based research program in the nation, with annual research operations of more than $1 billion and comprises more than 9,500 researchers working across more than 30 institutes, centers and departments. In July 2022, Mass General was named #8 in the U.S. News & World Report list of "America’s Best Hospitals." MGH is a founding member of the Mass General Brigham healthcare system.