DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C)

PHASE4CompletedINTERVENTIONAL
Enrollment

979

Participants

Timeline

Start Date

November 13, 2018

Primary Completion Date

November 30, 2020

Study Completion Date

December 30, 2022

Conditions
Hepatitis CDrug UseViral Hepatitis C
Interventions
DRUG

Sofosbuvir 400 mg and Daclatasvir 60 mg

All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.

DRUG

Sofosbuvir 400 mg and Daclatasvir 90 mg

For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.

DRUG

Ribavirin

"In case of cirrhosis:~* Ribavirin will be added to sofosbuvir/daclatasvir during the 12 weeks of treatment. The dose will be adapted to the patient weight although the vast majority of patients (weight \< 75 kg) will receive 500 mg x 2/day.~* In case of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks."

DRUG

Sofosbuvir and Daclatasvir for 24 weeks

In case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.

Trial Locations (2)

Unknown

Hai Phong University of Medicine and Pharmacy, Haiphong

Viet Tiep Hospital, Haiphong

All Listed Sponsors
lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT03537196 - DRug Use & Infections in ViEtnam - Hepatitis C (DRIVE-C) | Biotech Hunter | Biotech Hunter