Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may not be remedied even with the FDA label Gilead is seeking, infectious disease experts said.
Last December, the company announced a supplemental NDA (sNDA) regulatory application for its currently marketed HIV drug Truvada, a potential therapy to reduce the risk of acquiring HIV, commonly described as pre-exposure prophylaxis (PrEP). Truvada has been approved since 2004 for use in combination with other antiretroviral drugs to treat HIV infection.
Truvada has not been approved yet as a preventative therapy in HIV.
Results from the Phase III iPrEx study reported in the New England Journal Of Medicine in December 2010 showed prophylactic effect from Truvada given orally among men who have sex with men (MSM). In January 2011, the CDC issued interim guidance on the use of PrEP in this population.
While HIV therapy is much more manageable than previously, with fewer pills and side-effects, experts in recent years have begun to initiate therapy in earlier stages of the viral infection, and most recently in uninfected individuals to prevent infection. While multiple PrEP studies have reported encouraging data, multiple hurdles to adoption still remain.
Slow uptake thus far
This news service reported in December 2010 that uptake of Truvada as an HIV prophylaxis therapy would likely be slow, as non-HIV specialists would largely be responsible for prescriptions. Infectious disease specialists reported few, if any, prescriptions in this indication, when interviewed by this news service.
The University of North Carolina division of infectious disease has not been prescribing PrEP, said Dr Christopher Hurt, clinical assistant professor. He added there has been some talk in the medical community that primary care providers and potentially ob-gyns would be responsible for PrEP prescription, similar to how they are responsible for oral contraceptives.
He noted in some urban areas, particularly San Francisco, Boston, New York and Washington, DC, with stronger healthcare settings for MSM, have probably been prescribing PrEP more frequently as they regularly see those individuals at risk of HIV infection. He noted his clinic had some discussion about offering PrEP to partners of current patients, but no decision was finalized. Those partners need to be in care somewhere, where potential side effects can be monitored, he added.