Ledipasvir and Sofosbuvir in HIV Coinfection
Co-infection with HIV and hepatitis C virus (HCV) is relatively common because of shared routes of transmission.
Researchers enrolled 50 co-infected people with severe liver injury (cirrhosis) and assigned them to receive 12 weeks of ledipasvir + sofosbuvir.
Participants were divided into two groups based on their use (or not) of anti-HIV therapy (commonly called ART or HAART):
- untreated HIV infection -- 13 participants
- ART users -- 37 participants
The average profile of participants at the start of the study was as follows:
- 74% men and 26% women
- age -- 58 years
- HCV genotype 1a -- 78%
- HCV genotype 1b -- 22%
- HCV viral load -- 6 logs
- CD4+ cell counts -- 687 cells/mm3 in non-users of ART; 576 cells in ART users
Anti-HIV drugs that were allowed in this clinical trial included the following:
- a fixed-dose combination of FTC + tenofovir (Truvada)
- a fixed-dose combination of efavirenz + FTC + tenofovir (Atripla)
- rilpivirine (Edurant and in Complera)
- raltegravir (Isentress)
Among all participants who were not using ART, 100% (13 of 13) achieved an SVR12.
Among ART users, 97% (36 of 37) achieved an SVR12.
There were no significant changes to CD4+ cell counts or HIV viral load or toxicities to major organ-systems.
No deaths or premature departures from the study occurred.
For the Future
A larger study code-named ION-4 is ongoing in co-infected people. This trial has enrolled 335 participants with HCV genotypes 1 or 4, all of whom are using one of the following ART regimens:
- Complera (rilpivirine + Truvada)
- raltegravir + Truvada
ION-4 has enrolled participants from Canada, New Zealand and the U.S. Results are expected later in 2015 or early in 2016.
Townsend KS, Osinusi A, Nelson AK, et al. High efficacy of sofosbuvir/ledipasvir for the treatment of HCV genotype 1 in patients coinfected with HIV on or off antiretroviral therapy: Results from the NIAID Eradicate trial. In: Program and abstracts of The Liver Meeting, 7-11 November 2014. Abstract 84.