Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02596880

Acronym

SD100

Enrollment

100

Registered

2015-11-04

Start date

2015-09-30

Completion date

2016-06-30

Last updated

2023-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hepatitis C

Keywords

Hepatitis C, Cirrhosis, Sofosbuvir, Daclatasvir, Ribavirin

Brief summary

The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Detailed description

Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) \> 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Interventions

DRUGSofosbuvir

400 mg, included in a combination pill (Sovodak) with 60 mg daclatasvir

DRUGDaclatasvir

60 mg, included in a combination pill (Sovodak) with 400 mg sofosbuvir

DRUGRibavirin

1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Positive qualitative HCV RNA test on two occasions at least 6 months apart * Cirrhosis proven by either of: 1. Liver biopsy, 2. Liver elasticity \> 12 kilopascal (KPa), 3. Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)

Exclusion criteria

* Renal failure (eGFR \< 30 cc/min), * MELD score \> 20, * Child's C (CTP score \> 12), * Heart rate \< 50/min, * Taking amiodarone

Design outcomes

Primary

Measure	Time frame	Description
The sustained viral response rate	week 24 (12 weeks after end of treatment)	Qualitative HCV RNA polymerase chain reaction (PCR)

Secondary

Measure	Time frame	Description
Adverse drug events	week 2, 4, 8, 12, 24	Questionnaire

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026