Chronic hepatitis C
Conditions
Interventions
Patients with HCV genotype 1 (GT1) or serotype 1 receive ledipasvir (90 mg) plus sofosbuvir (400 mg) in a fixed-dose table (Product name: Harvoni) for 12 weeks.
Patients with HCV GT2 received sofosbuv
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients who regularly visit our hospital. Patients who infect with HIV-1 and HCV Blood HCV-RNA is positive in the time of enrollment. Patients who are receiving antiretroviral regimen for more than 8 weeks and to have evidence of HIV-1 viral suppression (HIV-1 RNA <200 copies per milliliter) with a CD4+ count of more than 100 cells per microliter in the time of enrollment. Patients who can prevent pregnancy from the initiation of DAA therapy to 24 weeks after the end of DAA treatment (total 36 weeks).
Exclusion criteria
Exclusion criteria: Patients with non-compensated cirrhosis Patients with severe renal impairment (eGFR<30ml/minute/1.73m2) Patients with HBs antigen positive Patients who have active opportunistic infection Other drugs are adequate for the patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful treatment is defined as sustained virological response at 12 weeks after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of safety: Grade 3/4 adverse events and discontinuation of study drugs. | — |
Countries
Japan
Contacts
Public ContactHaruka Uemura
National Center for Global Health and Medicine AIDS Clinical Center
Outcome results
None listed