Hepatitis C Virus Infection, Response to Therapy of, Human Immunodeficiency Virus
Conditions
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.
Interventions
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
Sponsors
RojanPharma Pharmaceutical Company
Tehran University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The sustained viral response rate | 12 weeks after end of treatment | Qualitative hepatitis C virus RNA polymerase chain reaction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug events | weeks 2, 4, 8, 12 and 24 | Questionnaire |
Countries
Iran
Outcome results
None listed