Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus (HIV200)

Tehran University of Medical Sciences

Status and phase: Completed; Phase 3

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

Treatments: Drug: sofosbuvir and daclatasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03369327

95-04-159-34058

Details and patient eligibility

About

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.

Full 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.

Enrollment: 232 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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232 participants in 1 patient group

sofosbuvir/daclatasvir

Experimental group

Description:

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

Treatment:

Drug: sofosbuvir and daclatasvir