An estimated 120,000 people in the US have started Truvada for pre-exposure prophylaxis (PrEP) since 2012, according to the latest findings from a survey of retail and mail-order pharmacies by Gilead Sciences.
The new numbers, presented at the 9th International AIDS Society Conference on HIV Science (IAS 2017) last month in Paris, are thought to be an underestimate. But changes in the survey results over time give an indication of how rapidly PrEP use has grown, and show that its use is still lagging in some of the groups most at risk for HIV infection.
The US Food and Drug Administration approved Truvada (tenofovir/emtricitabine) for HIV prevention in July 2012. Adoption was initially slow, but by late 2013 it began to rise steeply as gay and bisexual men started promoting PrEP within their communities. However, it is difficult to estimate the total number of people who have used PrEP because this information is not centrally collected.
At a conference in 2013 Gilead researchers first presented findings from a survey of just over half of US retail pharmacies, showing that fewer than 1300 Truvada prescriptions for PrEP were written in 2012. An update presented the following year brought the total to about 3250. In October 2015, Robert Grant of the University of California at San Francisco reported that prescriptions had more than doubled, reaching close to 8500.
At last summer's International AIDS Conference, Scott McCallister from Gilead presented an update showing that more than 79,000 people had started Truvada for PrEP between early 2012 and the end of 2015. While the methodology of the survey and the proportion of pharmacies included have varied over time, so the year-to-year numbers are not strictly comparable, they do show a rapid rise in PrEP use.
Numbers to 2016-2017
At the recent IAS meeting McCallister's team presented the latest survey results, adding detailed data on PrEP prescriptions to September 2016, as well as an estimate through the first quarter of 2017.
The survey looked at de-identified patient-level electronic prescription data from US retail pharmacies. The data represent more than 80% of Truvada prescriptions and were projected to account for all retail pharmacies and a small subset of non-retail pharmacies, according to the researchers.
Most Truvada PrEP use (80%) was tracked to retail or mail-order pharmacies and 4% to long-term care facilities. Among the pharmacies, 38% were chain stores, 17% were independent pharmacies, 10% were at clinics and 21% were mail-order. Federal facilities, prisons and university heath services accounted for less than 1%.
The survey's major limitation is that it does not include all the ways people may obtain PrEP outside of retail pharmacies. For example, it does not count people who receive PrEP through the Medicaid system or private PrEP programmes, such as the one at Kaiser Permanente in San Francisco, that do not report data to drug companies.
The analysis excluded Truvada prescriptions that probably were not for PrEP, such as those for HIV treatment (determined by a recorded HIV diagnosis, opportunistic illnesses or use of other antiretrovirals), post-exposure prophylaxis (PEP) or off-label treatment of hepatitis B (tenofovir is approved for this indication, but not the Truvada combination pill).
The survey found that 98,732 individuals started Truvada for PrEP since 2012, with 36,732 – more than a third of the total – doing so during 2016. The researchers estimated that by the first quarter of 2017 there were 120,000 people currently on PrEP.
PrEP use could be divided into three periods:
- Slow growth from the beginning of 2012 to the first quarter of 2014 (9% increase per quarter).
- Rapid growth between the second quarter of 2014 and the end of 2015 (17% increase per quarter).
- Stabilisation between the first and third quarter of 2016 (< 1% increase per quarter).
Over the four years, 83,672 PrEP users were men and 15,060 were women (the presentation did not specify whether they were cisgender or transgender); however, the proportions shifted over time. Women accounted for more than 40% of all PrEP starts in 2012, but from mid-2014 onward this fell to around 10%.
The average age of people starting PrEP was approximately 38 years for men and 35 years for women; 11% of the men and 24% of the women were under age 25, a group with a disproportionately higher risk of HIV infection.
The breakdown of PrEP users by race/ethnicity is more difficult, as this information is not routinely included in pharmacy records, but it was available for about 40% of them.
The survey showed that 73% of people starting PrEP were white, 13% were Latino/Hispanic, 10% were African American and 4% were Asian. This does not differ dramatically from the racial/ethnic distribution of the US population as a whole (about 61%, 18%, 12% and 6%, respectively, in 2016).
However, it does not reflect the distribution of the HIV epidemic in the US. According to the latest data from the Centers for Disease Control and Prevention, 45% of new HIV diagnoses occurred among African Americans, about 25% among whites, 24% among Latinos and 2% among Asians in 2015. Young black gay and bisexual men are at especially high risk.
"Despite this trend of increasing [PrEP] use in the USA, barriers to greater use in women and younger individuals at risk of HIV should be explored," the researchers concluded.
Mera R et al. Changes in Truvada for HIV pre-exposure prophylaxis utilization in the USA: 2012-2016. 9th International AIDS Society Conference on HIV Science, Paris, abstract WEPEC0919, July 2017.