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

Stanford University

Status and phase: Withdrawn; Phase 4

Conditions: PT-NANBH

Treatments: Drug: Simeprevir; Drug: Sofosbuvir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02485080

33431

Details and patient eligibility

About

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.

Full description

Key objectives of this study include:

1. To describe efficacy (SVR) in a special population of patients with chronic hepatitis C who are not willing or not candidates for IFN-based therapy.
2. To describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.

Sex: All

Ages: 18 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Simeprevir + sofosbuvir daily, 24 weeks

Experimental group

Description:

Eligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions.

Treatment:

Drug: Sofosbuvir

Drug: Simeprevir