This study will evaluate the safety and efficacy of sofosbuvir (SOF)-based regimens administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.
Study Type
OBSERVATIONAL
Enrollment
532
SOF tablets administered orally once daily based on approved prescribing information
Global Hospitals
Hyderabad, Andhra Pradesh, India
Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen
Time frame: Up to Posttreatment Week 4
Proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12)
SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ) 12 weeks following the last dose of study drug, respectively.
Time frame: Posttreatment Week 12
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A.I.I.M.S.
New Delhi, Ansari Nagar, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, India
Artemis Hospital
Gurgaon, Haryana, India
Manipal Hospital
Bengaluru, Karnataka, India
BGS global Hospitals
Bengaluru, Karnataka, India
Lakeshore Hospital
Kochi, Kerala, India
Midas Institute of Gastro-enterology
Nagpur, Maharashtra, India
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
SMS Medical College & Hospital
Jaipur, Rajasthan, India
...and 16 more locations