Truvada patent expires, potentially opening ‘new doors’ for PrEP access
The patent for the HIV medication Truvada expired today, potentially creating an opportunity for a generic PrEP option for patients.
“The real question will be whether this transition affects access, both through insurance plans that might select a less expensive option or through lower direct costs to patients themselves. One key question is whether the cost will be materially different, however,” Jeanne M. Marrazzo, MD, MPH, Infectious Diseases News Editorial Board Member and director of the division of infectious diseases at University of Alabama at Birmingham School of Medicine, told Healio.
“We have seen cases where generic alternatives have only minimally offered less costly alternatives, and that really hasn’t shifted uptake in a positive direction at all,” Marrazzo said. “We know that a substantial number of people at risk for HIV acquisition who could benefit from PrEP aren’t accessing it, for complex reasons ranging from stigma to cost. Any movement that could ease access would be welcome.”
Teva Pharmaceuticals will launch a generic version of both Truvada (emtricitabine/tenofovir disoproxil fumurate; FTC/TDF) and the treatment Atripla (FTC/TDF/efavirenz). Gilead Sciences announced the early expiration of the patent for FTC/TDF last year, and Teva’s generic FTC/TDF was originally approved in 2017.
Gilead confirmed to Infectious Disease News that the patent expired as planned today.
“This may give physicians more options within their prescribing universe — for example, coverage of a generic option might be more acceptable to insurers,” Marrazzo said. “It may also serve to remind physicians of the importance of PrEP, and to heighten their awareness and likelihood of gauging whether patients might benefit from it and facilitate access for them.”
Marrazzo said questions remain regarding what the change will mean for PrEP users.
“The key is whether this will open new doors for access to PrEP for patients who need it,” Marrazzo said. “Will it make it more affordable? Accessible? Likely to be addressed by physicians? Likely to be brought up by patients? I hope all these avenues turn out to be explored and PrEP uptake overall is better.”
Gilead’s second-generation PrEP medication, Descovy (emtricitabine/tenofovir alafenamide) was approved by the FDA last year.