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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus

Conditions
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Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: sofosbuvir and daclatasvir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sofosbuvir/daclatasvir<br>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 | Drug: sofosbuvir and daclatasvir<br>* Depending on the ART received by each patient one of the fixed-dose combination pills below will be used: Daclatasvir 30 mg and sofosbuvir 400 mg Daclatasvir 60 mg and sofosbuvir 400 mg Daclatasvir 90 mg and sofosbuvir 400 mg<br>* Other names: Sovodak 90/400;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sustained viral response rate | Qualitative hepatitis C virus RNA polymerase chain reaction | 12 weeks after end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug events | Questionnaire | weeks 2, 4, 8, 12 and 24 |