Clinical trial NCT03369327: Sofosbuvir and Daclatasvir for Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
Official title: Efficacy of a Fixed-Dose Combination Pill of Sofosbuvir and Daclatasvir in Treating Hepatitis C in 200 Patients Co-infected With Human Immunodeficiency Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection, Response to Therapy of
Human Immunodeficiency Virus
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: RojanPharma Pharmaceutical Company
First posted: 2017-12-12
Enrollment: 232
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The sustained viral response rate
timeFrame: 12 weeks after end of treatment
Secondary outcomes:
measure: Adverse drug events
timeFrame: weeks 2, 4, 8, 12 and 24
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Emam Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Reza Malekzadeh
role: STUDY_CHAIR
References:
citation: 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.