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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF-based regimens | Adults with chronic HCV infection in India who are being treated with a SOF-based treatment regimen as per the approved prescribing information. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | SOF tablets administered orally once daily based on approved prescribing information |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions (ADRs) during treatment and up to 4 weeks after discontinuation of a SOF-based regimen | Up to Posttreatment Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Posttreatment Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Adults residing in India aged ≥ 18 years, who are infected with HCV, and for whom the treating physicians in the participating clinics have prescribed a SOF-based regimen as per the approved prescribing information.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Hospitals | Hyderabad | Andhra Pradesh | 500 004 | India | ||
| A.I.I.M.S. |
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| New Delhi |
| Ansari Nagar |
| 110029 |
| India |
| Nirmal Hospital Pvt. Ltd. | Surat | Gujarat | 395002 | India |
| Artemis Hospital | Gurgaon | Haryana | 122001 | India |
| Manipal Hospital | Bengaluru | Karnataka | 560017 | India |
| BGS global Hospitals | Bengaluru | Karnataka | 560098 | India |
| Lakeshore Hospital | Kochi | Kerala | 682040 | India |
| Midas Institute of Gastro-enterology | Nagpur | Maharashtra | 440 010 | India |
| S.R. Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | 302001 | India |
| SMS Medical College & Hospital | Jaipur | Rajasthan | 302004 | India |
| Marudhar Hospital | Jaipur | Rajasthan | 302012 | India |
| Global Hospitals & Health City | Chennai | Tamil Nadu | 600100 | India |
| VGM Hospital | Coimbatore | Tamil Nadu | 641 005 | India |
| KGMU Medical College | Lucknow | Uttar Pradesh | 226003 | India |
| Postgraduate Institute of Medical Education and Research | Chandigarh | Uttarakhand | 160012 | India |
| Institute of Post Graduate Medical Education And Research | Kolkata | West Bengal | 700 020 | India |
| Sanjivani Superspeciality Hospital Clinical Research Department | Ahmedabad | 380015 | India |
| Saviour Hospital | Ahmedabad | 380015 | India |
| Sri Ramachandra Medical College and Research | Chennai | 600116 | India |
| Aware Global Hospital | Hyderabad | 500035 | India |
| M.V. Hospital and Research Centre | Lucknow | 226003 | India |
| K. R. M. Hospital & Research Centre | Lucknow | 226010 | India |
| Dayanand Medical College & Hospital | Ludhiana | 144001 | India |
| BYL Nair Hospital & T N Medical College | Mumbai | 400008 | India |
| Sir Ganga Ram Hospital | New Delhi | 110060 | India |
| Om Research Center, Om Surgical Center & Maternity Home | Varanasi | 221007 | India |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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