The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
400/100 mg FDC tablet(s) administered orally once daily
Seth GS Medical College and KEM hospital
Mumbai, Maharashtra, India
Government Medical College & Super Speciality Hospital
Nagpur, Maharashtra, India
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time frame: Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time frame: Up to Week 12
Percentage of Participants With Virologic Failure
Virologic failure was defined as the following: * On Treatment Virologic Failure: HCV RNA persistently ≥ LLOQ through 12 weeks of treatment (nonresponse), or * Relapse: HCV RNA ≥ LLOQ at Posttreatment Week 12 having achieved HCV RNA \< LLOQ at end of treatment.
Time frame: Up to Posttreatment Week 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
Delhi, New Delhi, India
Global Hospital-Super Speciality & Transpant Centre (A Unite of Centre for Digestive & Kidney Diseases (India) PVT LTD.
Mumbai, Parel, India
Post Graduate Institute of Medical Education and Resesarch (PGIMER)
Chandigarh, Punjab, India
YRG Care
Chennai, Tamil Nadu, India
VGM Hospital - Institute of Gastroenterology
Coimbatore, Tamil Nadu, India
Gandhi Hospital
Secunderabad, Telangana, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
...and 6 more locations