The primary objectives of this study are to describe the efficacy of: 1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 2. 12-week treatment of SOF/LED for all other HCV-6 populations
The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Stanford University Medical Center
Palo Alto, California, United States
San Jose Gastroenterology
San Jose, California, United States
Liver and Digestive Consultants
Houston, Texas, United States
Digestive Health Associates
Plano, Texas, United States
Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment
Time frame: 12 weeks after end of therapy
Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.
Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Time frame: Day 1 of treatment to 12 weeks post treatment
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