Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

Not Recruiting

Trial ID: NCT02485080


The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.

Official Title

Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health


Inclusion criteria:

   1. Adult 18-72 years

   2. Cirrhosis: defined by stage 4 on biopsy or noninvasive tests or presence of
   splenomegaly and platelet of 130K or lower, or presence of shrunken nodular liver on
   CT or MRI, or presence of varices or encephalopathy or ascites.

   3. HCV genotype 1 or indeterminate and later assessed at Screening and confirmed as
   genotype 1

Exclusion criteria:

   1. Uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled
   esophageal/gastric varices

   2. Co-infection with HIV or hepatitis B (HBV)

   3. CPT 7 or above, or MELD >10

   4. Total bilirubin 4.0 mg/dL or above

   5. CrCl (creatinine clearance) < 30 mL/min

   6. Any unstable active medical illnesses.

   7. Active use of illicit substances, alcohol, or smoking.

   8. Any malignancy within last 5 years except for basal cell skin cancer that has been
   adequately treated or HCC within Milan or UCSF criteria, which will be acceptable

   9. Any prior treatment with direct acting antivirals (approved or investigational),
   including HCV protease inhibitors, such as SMV. Patients who received prior treatment
   with SOF, and/or NS5A inhibitors (e.g. ledipasvir or Daclatasvir) can be included in
   this study

10. Platelet < 30 K/uL


drug: Simeprevir

drug: Sofosbuvir

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie H Nguyen, MD, MAS