National Center for Health Research; December 20, 2018
National Center for Health Research’s Public Comments on the
USPSTF’s Draft Recommendation Statement – Prevention of Human Immunodeficiency
Virus (HIV) Infection: Pre-Exposure Prophylaxis
Thank you for the opportunity to share our views regarding the draft recommendation on the prevention of HIV infection using pre-exposure prophylaxis (PrEP). The National Center for Health Research is a nonprofit research center that conducts, analyzes, and reviews research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from pharmaceutical companies and have no financial ties to this issue.
We agree with the recommendation for using PrEP to prevent HIV infection for people at high risk. As discussed in the recommendation and review, between 2013 and 2016 approximately 40,000 people were diagnosed with HIV infection each year in the United States. Although HIV is manageable with antiretroviral therapy, it is not curable. HIV increases the risk for very serious health issues, including respiratory infections, cancers, cardiovascular diseases, and problems of the central nervous system.
As discussed in the recommendation and review, there are no well-validated and accurate risk assessment tools that can accurately identify people at high risk of acquiring HIV. However, we agree that there is sufficient epidemiological evidence to recommend that physicians discuss the possible use of PrEP with patients at high risk, such as 1) people who inject drugs and share drug injection equipment and 2) men who have sex with men or heterosexual people who either have a serodiscordant sex partner, or use condoms inconsistently with partners whose HIV status is not known and who are at a high risk, or in some cases people who have had a recent bacterial STI. Other factors, such as the local prevalence of HIV, also affect an individual’s likelihood of acquiring HIV. This discussion and evaluation of all of a person’s risk factors and personal preferences should identify patients for whom the benefits of PrEP outweigh its risks. Moreover, this discussion should also include other methods to decrease risk, including consistent condom use.
PrEP can cause problems with the kidneys and gastrointestinal system, as well as bone loss. However, the evidence suggests that benefits of PrEP can outweigh its risks for people at high risk.
We agree with the concern about the lack of studies on the long-term safety of PrEP. We further agree that there is a need for better research to determine the risks of PrEP use in adolescents and pregnant or breast feeding women. As more information becomes available on the use of PrEP in pregnant or breastfeeding women, adolescents, and on the long-term safety of PrEP, we encourage USPSTF to re-evaluate its recommendations.
In summary, we support USPSTF’s draft recommendation on the use of pre-exposure prophylaxis for high risk populations.
Thank you for the opportunity to comment on this important issue.
The National Center for Health Research can be reached through Stephanie Fox-Rawlings at sfr@center4research.org.