Trial | NCT03369327  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    232
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.
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 Started
Jan 01
2017
Primary Completion
Sep 01
2018
Study Completion
Dec 01
2018
Last Update
Feb 20
2019

Drug sofosbuvir and daclatasvir [sofosbuvir (sovaldi), daclatasvir (daklinza)]

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

  • Other names: Sovodak 30/400, Sovodak 60/400, Sovodak 90/400

sofosbuvir/daclatasvir Experimental

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

Criteria 

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
No Results Posted