The Dutch Acute Hepatitis C in HIV Study

Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of ACUTE hepatitis C genotype 1 or 4.

Over the last 2 years, the treatment of Hepatitis C (HCV) underwent an enormous change in a positive way. New direct acting antivirals (DAA) given in combination were shown to cure 95% of chronically HCV infected patients. Grazoprevir and elbasvir combination therapy is such a new DAA therapy. However, these new therapies have never been studied in patients with acute HCV. The only approved treatment for acute HCV is interferon but is associated with serious side-effects which limits it use. In the past it was shown that interferon therapy was much more effective when it was given during acute than during chronic HCV. It is unclear if the same is true for DAA therapy.

Study design: 80 acute HCV genotype 1 or 4 infected patients co-infected with HIV from 10 Dutch study sites will receive 8 weeks of grazoprevir and elbasvir. This will be the largest study ever performed on the treatment of acute HCV with an interferon-free therapy.

If this study shows that graprevir and elbasvir are effective for the treatment of acute HCV, it will make the treatment of patients with acute HCV much easier. The current treatment of acute HCV is based on interferon and is associated with sometimes very severe side effects. Therefore many patients are not willing or able to receive treatment for their acute HCV infection. Curing acute HCV means that less transmission of HCV will occur. Therefore a better treatment option for acute HCV will lead to a reduction of HCV transmission and a reduction in the prevalence. Therefore, if shown to be effective for the treatment of acute HCV as well, it will be an important improvement in the therapy of acute HCV.

For more detailed information about this study, click here.

Summary
In this multi-center study, we will for the first time investigate if grazoprevir and elbasvir therapy is effective when given during acute HCV infection. 80 acute HCV genotype 1 or 4 infected patients co-infected with HIV from 10 Dutch study sites will receive 8 weeks of grazoprevir and elbasvir.
Technology Readiness Level (TRL)
8
Time period
28 monts
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