The success of linking most diagnosed HIV patients to care so that they receive treatment in the major markets has been a key part of controlling the spread of HIV, but diagnosed and undiagnosed patients who are not virally suppressed remain. One strategy to further combat the spread of HIV is the utilization of Gilead’s Truvada for HIV Pre-Exposure Prophylaxis (PrEP), a pharmacological method to provide protection for those at high risk of contracting the virus.

The clinical data supporting the use of Truvada for HIV PrEP has been remarkable. The iPrEx study, a randomized, double-blind trial that examined whether daily use of oral Truvada could prevent HIV infection in men who have sex with men (MSM), found a 99% protection rate associated with daily use. However, the question remained whether Truvada for HIV PrEP could make a substantial impact on HIV incidence.

At the July 2018 International AIDS Symposium (IAS), Gilead presented data from 2012 to 2016 that demonstrated an overall decrease in HIV incidence in the United States from 15.7 to 14.5 cases per 100,000 people. A key driver of this decrease in incidence looks to be Truvada for PrEP, as usage of PrEP directly correlated with decreased incidence at the state-level across a subset of 38 states and Washington, D.C., where virologic suppression data was available. In the 2012 to 2016 study period, the ten states with the highest PrEP uptake observed a 4.7 percent decline in HIV incidence. In contrast, the ten states with the lowest PrEP usage observed a 0.9 percent increase in prevalence. This study provides the first the direct observation of the impact of Truvada for PrEP on HIV incidence and the efficacy of PrEP is quite outstanding.

While the recent data support the conclusion that Truvada for PrEP is effective in reducing incidence, overall uptake is low in the United States. Patient advocacy groups are critical of the current state of access to Truvada for PrEP, noting that generic Truvada isn’t expected to enter the United States market until 2021, thereby creating a patient-level cost barrier for many who would be indicated for HIV PrEP. These advocacy groups believe that reimbursement is the largest road block to widespread PrEP usage. HIV experts interviewed by Decision Resources Group cite PrEP education and awareness among both those at high risk of contracting HIV and providers as the biggest constraints to the uptake of PrEP. According to these interviewed experts, there is a reluctance among high risk individuals, even those who are educated on the benefits of Truvada for PrEP, to openly speak of their sexual behavior with their health care providers. Participation in high-risk sexual behavior, or sex with those individuals, is a requirement, along with testing for sexually transmitted infections, to receive a prescription of Truvada for PrEP. Therefore, improvements in the patient and provider relationship will be critical to drive future uptake of PrEP, though it will likely take a major cultural shift to enhance communication between eligible patients and providers. Initiatives like New York City’s “PlaySure” that encourage education and open communication about safe sexual health practices are likely the key first steps to making changes in community.

Truvada for PrEP as a single initiative is unlikely to be effective in curbing the HIV epidemic, though the data from IAS 2018 indicates that PrEP may be an increasingly important part of the strategy along with treatment as prevention in lowering HIV incidence. For a more in depth analysis of HIV PrEP and a 10-year annualized forecast of the G7 HIV PrEP indicated population, please see Decision Resources Group’s recent report, the 2018 Human Immunodeficiency Virus Disease Landscape & Forecast.

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