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

NCT ID: NCT03369327

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-12-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sofosbuvir/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

Group Type: EXPERIMENTAL

sofosbuvir and daclatasvir

Intervention Type: DRUG

Depending on the ART received by each patient one of the fixed-dose combination pills below will be used:

1. Daclatasvir 30 mg and sofosbuvir 400 mg

2. Daclatasvir 60 mg and sofosbuvir 400 mg

3. Daclatasvir 90 mg and sofosbuvir 400 mg

Interventions

sofosbuvir and daclatasvir

Depending on the ART received by each patient one of the fixed-dose combination pills below will be used:

1. Daclatasvir 30 mg and sofosbuvir 400 mg

2. Daclatasvir 60 mg and sofosbuvir 400 mg

3. Daclatasvir 90 mg and sofosbuvir 400 mg

Intervention Type: DRUG

Other Intervention Names

Sovodak 30/400; Sovodak 60/400; Sovodak 90/400

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RojanPharma Pharmaceutical Company

UNKNOWN

Sponsor Role: collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reza Malekzadeh

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Locations

Shariati Hospital

Tehran, , Iran

Emam Hospital

Tehran, , Iran

Countries

Iran

References

Dehghan Manshadi SA, Merat S, Mohraz M, Rasoolinejad M, Sali S, Mardani M, Tabarsi P, Somi MH, Sedghi R, Tayeri K, Nikbin M, Karimi J, Sharifi AH, Kalantari S, Norouzi A, Merat D, Malekzadeh Z, Mirminachi B, Poustchi H, Malekzadeh R. Single-pill sofosbuvir and daclatasvir for treating hepatis C in patients co-infected with human immunodeficiency virus. Int J Clin Pract. 2021 Aug;75(8):e14304. doi: 10.1111/ijcp.14304. Epub 2021 May 17.

Reference Type: DERIVED

PMID: 33930223 (View on PubMed)

Other Identifiers

95-04-159-34058

Identifier Type: -

Identifier Source: org_study_id