Earlier this month, the UK’s high court ruled that there was no legal reason the National Health Service (NHS) should not offer Gilead’s Truvada for HIV pre-exposure prophylaxis (PrEP). This news comes about five months after the NHS declared it was not their responsibility to provide coverage for HIV prophylaxis. Needless to say, the initial NHS announcement elicited strong disapproval from physicians and the public alike, especially given the long delay in availability of PrEP in Europe. The use of Truvada for PrEP was only approved by the EMA in August 2016, four years after its approval in the US.
The FDA approval of Truvada for PrEP in 2012 made it the first and only drug to be approved for HIV prophylaxis. Having initially been approved for the treatment of HIV, Truvada’s expanded label including HIV prophylaxis was met with limited enthusiasm from payers, treatment providers and at-risk uninfected individuals. In particular, payers and treatment providers questioned the use of a pharmacological prophylaxis when condoms are a highly cost-effective means of reducing the risk of contracting HIV. However, public opinion of PrEP has since improved as demonstrated by the increased uptake of Truvada for HIV PrEP, with an estimated 80 thousand individuals having used the drug between 2012 and 2015 in the US.
To date, the clinical data supporting the use of Truvada for HIV PrEP has been very positive. The iPrEx study, a randomized, double-blinded trial that examined whether daily use of oral Truvada could prevent HIV infection in men who have sex with men (MSM), found that for those who adhered to a minimum of four doses of Truvada per week, PrEP was 96% effective at preventing HIV infection. This protection rises to 99% when patients adhered to a daily regimen. Numerous additional trials in major markets, including those in the EU, such as the UK PROUD trial and the IPERGAY trial in France (a study that evaluated Truvada use around a high-risk event instead of regularly), have further supported Truvada’s use for HIV PrEP. Cumulatively, these studies indicate that Truvada is at least 96% effective in preventing HIV infection with timely administration. Overall, these clinical trials have eliminated any major concern that use of Truvada for HIV PrEP will not be an effective prophylactic drug. Moreover, further commercial opportunity still exists in the HIV PrEP market, as drug developers seek to create options with long-acting formulations.
Beyond efficacy, with payer budgets already struggling to provide HIV therapies for infected individuals, cost remains a key constraint to the widespread use of Truvada for HIV PrEP. In the four years since Truvada’s label expansion, U.S. payers have been slow to include Truvada for PrEP on their formularies. However, fueled in part by the public health demands to eliminate HIV, and in part by the long-term cost associated with HIV care, more payers are starting to cover Truvada for PrEP as well as loosening prescribing restrictions for PrEP. This shift in formulary positioning in combination with increased patients awareness of Truvada for HIV infection prevention has therefore led to an increase in prescribing.
The years since Truvada’s label expansion to include PrEP have seen a shift in the public’s perception of a pharmacological prophylaxis for HIV. When Truvada was first approved for PrEP, its prophylactic use in many high-risk groups was actively discouraged by treating physicians, equating prescribing of PrEP to the endorsement of sexual promiscuity. However, since then, a massive education effort by both physicians and patient advocacy groups has led to a reform in public thinking. Indeed, patient advocacy groups have launched campaigns to bring tailored messaging of HIV PrEP benefits to high-risk groups, encouraging at-risk individuals to be proud of making intelligent health-related choices. Nevertheless, uninfected individuals still need to actively seek out physicians open to prescribing PrEP, often the physicians managing their seropositive partners, highlighting that patient education alone is not enough. These messaging campaigns must therefore also target general practitioners, such as primary care physicians.
Truvada for HIV PrEP has the potential to make a real difference in the incidence of new HIV infections outside of the US as well. Several EU countries, such as the UK, have already succeeded in getting nearly all their HIV positive patients virally suppressed, as outlined in the UNAIDS 90/90/90 initiative – 90% diagnosed/90% drug-treated/90% virally suppressed. With the majority of the diagnosed HIV population successfully managed in many countries, some control over the HIV epidemic is in place as virally suppressed individuals are less likely to infect their sexual partners. PrEP has the potential to further curb the incidence of HIV infections, thereby allowing some nations to stem back expansion of the HIV epidemic. However, cost concerns are likely to serve as the largest barrier towards the widespread adoption of Truvada for HIV PrEP in EU markets. As such, each country in the EU will face unique challenges in the effort to include HIV PrEP into their single payer systems.
Overall, PrEP alone will not be able to prevent all new HIV infections. As such, there needs to be support for other initiatives, like the UNAIDS’ 90/90/90, which not only benefits diagnosed HIV patient health and well-being, but can also help prevent new infections. This “treatment as prevention” approach, can help justify high drug-treatment rates, and the associated increased cost, in order to help reduce the number of new infections. While no single initiative will be sufficient to curb the HIV epidemic, PrEP is poised to be an increasingly important part of a comprehensive strategy that includes HIV education, prophylaxis and widespread treatment. Nevertheless, short of an HIV vaccine, we have a number of effective tools at our disposal. It’s just a matter of putting them to use.
Additional in-depth analyses of the HIV market are available here.