This is an open-label, single arm, multicenter, pilot-study to compare the efficacy and safety of LDV/SOF fixed dose combination (FDC) in subjects with acute genotype 1 HCV infection. A total of 20 subjects will be assigned to receive LDV/SOF FDC tablet (LDV 90 mg/SOF 400 mg/) once daily for 6 weeks.Patients will be followed up for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Ledipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily
Efficacy of treatment with ledipasvir (LDV)/sofosbuvir (SOF) FDC (proportion of subjects with sustained viral response (HCV RNA < LLOQ TND) using COBAS TaqMan Realtime PCR)
To evaluate the efficacy of treatment with ledipasvir (LDV)/sofosbuvir (SOF) FDC for 6 weeks in patients with acute genotype 1 HCV infection as measured by the proportion of subjects with sustained viral response (HCV RNA \< LLOQ TND) 12 weeks after discontinuation of therapy (SVR 12) using COBAS TaqMan Realtime PCR.
Time frame: 12 weeks
Safety and tolerability of LDV/SOF FDC-containing regimens (frequency of AEs and SAEs)
To evaluate the safety and tolerability of LDV/SOF FDC-containing regimens administered for up to 6 weeks in patients with acute genotype 1 HCV infection as measured by the frequency of AEs and SAEs assessed at end of treatment, 12 and 24 weeks after end of treatment.
Time frame: 24 weeks after treatment
Durability of response (proportion of subjects with sustained viral response (HCV RNA < LLOQ TND)
To determine the durability of response after discontinuation of therapy as measured by the proportion of subjects with sustained viral response (HCV RNA \< LLOQ TND) 24 weeks after discontinuation of therapy (SVR 24).
Time frame: 24 weeks after treatment
Kinetics of circulating HCV RNA (mean viral load)
To evaluate the kinetics of circulating HCV RNA measured as mean viral load during treatment (Baseline, week 2,4,6) and after treatment discontinuation (Follow up week 4, 12, 24)
Time frame: 24 weeks after treatment
Emergence of viral resistance to LDV/SOF FDC
To evaluate the emergence of viral resistance to LDV/SOF FDC during treatment and after treatment discontinuation
Time frame: 24 weeks after treatment
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...and 10 more locations