The purpose of this study is to assess the rate of sustained virological response (SVR) 12 weeks after 8-week oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4.
Increasing rates of acquisition of HCV in men who have sex with men (MSM) have been reported since 2001 in Western European countries and particularly in France. Observational studies have recently reported that HIV-infected gay and bisexual men with sexually transmitted hepatitis C have shown unexpectedly rapid liver disease progression in a relatively short period of time. It is therefore admitted that, in the absence of a spontaneous HCV clearance within 3 months of acute HCV infection, treatment should be initiated. Pegylated interferon in combination with weight-adapted ribavirin is still recommended as the treatment of choice for all HCV genotypes in an acute setting. For patients developing a rapid virologic response, treatment duration of 24 weeks is recommended. If antiviral therapy was initiated within 24 weeks after diagnosis, sustained virologic response rates of 60 to 80% have been observed at the price of a high side effects burden. However, short course therapies with new direct acting antivirals are likely to be safer and more efficient. But their efficacy in acute hepatitis C has still to be established. To date, US- and Europe- based trials are ongoing in this setting with the association of sofosbuvir and ribavirine, sofosbuvir / ledipasvir or sofosbuvir / simeprevir, for a duration of 4, 6, 8 or 12 weeks. Preliminary results are very diverse, with SVR12 ranging from 56% to 95%. MSD has been evaluating the efficacy and safety of a double drug combination (grazoprevir + elbasvir) in HIV-infected patients which exhibits paramount efficacy and excellent tolerance in a diverse range of genotypes, including 1 and 4 HCV strains, which are those mainly encountered in the French acute HCV epidemics in MSM. This association has the potential to be used for short treatment duration especially with regards to the fact that patients will have no fibrosis at the time of treatment initiation. This MRK-combo would therefore be an ideal candidate for treating acute hep C due to GT1 or 4 in a "test and treat" approach in high-risk population such as MSM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks
CHU de Lyon
Lyon, France
CHU de Nice
Nice, France
Hôpital Saint-Antoine
Paris, France
Hôpital La Pitié-Salpêtrière
Paris, France
Hôpital Bichat
Sustained Virological Response 12 Weeks Post-treatment (SVR12)
Undetectable plasma HCV RNA (\<12 IU/mL) 12 weeks post-treatment.
Time frame: 12 weeks
Virological Failure
Number of patients harboring HCV (NS5A and NS3/4) resistance mutations 12 weeks post treatment
Time frame: 12 weeks
Treatment Adherence
Number of patients missing study drug within the last four days during treatment
Time frame: 8 weeks
Number of Participants With Undetectable HIV RNA
Number of participants with undetectable HIV RNA at 12 weeks post treatment (in HIV-positive co-infected patients)
Time frame: 12 weeks
CD4 Cell Count
CD4+ T cell count at 12 weeks post treatment (in HIV-positive co-infected patients)
Time frame: 12 weeks
Incidence of HCV Re-infection
Number of patients with positive HCV RNA 48-weeks post treatment.
Time frame: 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Paris, France
Hôpital Tenon
Paris, France