All patients with HCV, both mono-infected or HIV co-infected are at risk for complications derived from the course of the disease and may, in the end, require a liver transplant. In addition, in patients with HIV, the viral load is higher, the disease progresses faster and there are fewer treatment options.
In this multicenter international phase II trial the antivirals grazoprevir and elbasvir were administered, with or without ribavirin, for 8 or 12 weeks to 218 patients with previously untreated hepatitis C (159 with HCV and 59 HIV-infected). The parallel administration of the treatment to mono and co-infected patients is novel because HIV patients are usually enrolled in independent clinical trials. Thus, this study represents a unique opportunity to assess the role of HIV infection in response to HCV treatment.
The results indicate that the 12 week treatment was well tolerated and between 87 and 98% of participants in the study achieved HCV RNA less than 25 IU/ml, indicating a sustained virological response or, in other words, the hepatitis C curation. This response was similar for both mono and co-infected patients, suggesting that this combination of drugs provides an effective and safe treatment option for the two groups.
With these promising results for the curation of hepatitis C with only 12 weeks of treatment and a very good tolerance, several phase III clinical trials have been launched that will evaluate the effectiveness of this therapeutic approach in a higher number of patients.
Efficacy and safety of 8 weeks versus 12 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin in patients with hepatitis C virus genotype 1 mono-infection and HIV/hepatitis C virus co-infection (C-WORTHY): a randomised, open-label phase 2 trial
Sulkowski M, Hezode C, Gerstoft J, Vierling JM, Mallolas J, Pol S, Kugelmas M, Murillo A, Weis N, Nahass R, Shibolet O, Serfaty L, Bourliere M, DeJesus E, Zuckerman E, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B.
Lancet. 2014 Nov 11. pii: S0140-6736(14)61793-1. doi: 10.1016/S0140-6736(14)61793-1. [Epub ahead of print]