Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

Phase 3

Completed

• Conditions: Human Immunodeficiency Virus; Hepatitis C Virus Infection, Response to Therapy of
• Interventions: Drug: sofosbuvir and daclatasvir

• Registration Number: NCT03369327
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

In a multi-center study 200 patients co-infected with hepatitis C virus (HCV) and human immunodeficiency virus (HIV) will be treated with a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular antiretroviral treatment (ART) being used by the patient. The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

Detailed Description

To achieve the goal of elimination of hepatitis C in 2030 as set forward by the world health organization (WHO) a main group requiring treatment are subjects co-infected with HIV. These subjects offer a particular challenge as they are receiving ART which frequently interferes with hepatitis treatment. The number of pills they are already taking also limits the compliance of these patients.

In order to evaluate the efficacy of a fixed-dose combination pill combined of 400 mg sofosbuvir and 30, 60, or 90 mg of daclatasvir - depending on the particular ART medicine being used by the patient - a multi-center study of 200 co-infected patients has been designed.

The treatment duration will be 12 weeks for subjects without cirrhosis and 24 weeks for those with cirrhosis.

The study is one of the pilots being run for hepatitis C elimination in Iran.

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Primary Completion: 2018-09-01
• Study Completion: 2018-12-01
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

Inclusion Criteria

• Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
• Positive human immunodeficiency virus test

Exclusion Criteria

• Heart rate < 50/min,
• Taking amiodarone
• Renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sofosbuvir/daclatasvir	sofosbuvir and daclatasvir	Once daily fixed-dose combination pill of sofosbuvir and daclatasvir for 12 weeks if the patient is non cirrhotic and for 24 weeks if cirrhotic

Primary Outcome Measures

Name	Time	Method
The sustained viral response rate	12 weeks after end of treatment	Qualitative hepatitis C virus RNA polymerase chain reaction

Secondary Outcome Measures

Name	Time	Method
Adverse drug events	weeks 2, 4, 8, 12 and 24	Questionnaire

Trial Locations

Locations (2)

Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

Emam Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of