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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This use-results post-marketing surveillance (PMS) study for Sovaldi® tablets (sofosbuvir, SOF) administered in combination with Rebetol® capsules (ribavirin, REB) will evaluate the safety and efficacy of SOF administered in combination with ribavirin under real world use in Japan. Among adult patients with chronic genotype 2 hepatitis C virus (HCV) infection and treated with SOF+ribavirin in routine clinical use, the primary objective of this study is to evaluate the incidence of adverse drug reactions (ADRs) under real world settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+REB | Adult patients with genotype 2 chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | SOF 400 mg tablets administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reaction (ADR) under real world settings | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24) | SVR12 and SVR24 are defined as HCV RNA < the lower limit of quantification (LLOQ) 12 and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 12 and 24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Adult patients with serogroup 2 (genotype 2) chronic HCV infection with or without compensated cirrhosis who take SOF+REB as part of routine clinical care at a participating clinical site.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageo-shi | Japan | |||||
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Whole blood
| REB | Drug | REB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (< 60 kg = 600 mg , > 60 kg to †80 kg = 800 mg, and > 80 kg = 1000 mg) |
|
|
| Proportion of participants with HCV NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks |
| Approximately 12 weeks after treatment completion or discontinuation |
| BunkyÅ City |
| Japan |
| Chuo-shi | Japan |
| Fujioka-shi | Japan |
| Fukui-shi | Japan |
| Fukuoka | Japan |
| Hakodate-shi | Japan |
| Handa-shi | Japan |
| Ichihara-shi | Japan |
| Inashiki-gun | Japan |
| Iruma-gun | Japan |
| Kamogawa-shi | Japan |
| Karatsu-shi | Japan |
| Kashiwa-shi | Japan |
| Katsushika-ku | Japan |
| Kawagoe-shi | Japan |
| Kawasaki-shi | Japan |
| Kitamoto-shi | Japan |
| Kobe | Japan |
| Kodaira-shi | Japan |
| KÅtoku | Japan |
| Kurume-shi | Japan |
| Kyoto | Japan |
| Matsue | Japan |
| Matsuyama | Japan |
| Minatoku | Japan |
| Miyazaki | Japan |
| Morioka | Japan |
| Nagoya | Japan |
| Osaka | Japan |
| Osakasayama-shi | Japan |
| Saitama-shi | Japan |
| Sakaishi | Japan |
| Sapporo | Japan |
| Shibuya-ku | Japan |
| Shimotsuke-shi | Japan |
| Shinjuku-ku | Japan |
| Sumida-ku | Japan |
| Tagawa-shi | Japan |
| Tondabayashi-shi | Japan |
| Toyama | Japan |
| Toyoake-shi | Japan |
| Utsunomiya | Japan |
| Yanagawa-shi | Japan |
| Yokohama | Japan |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D007239 | Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| 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 |
| D012254 | Ribavirin |
| 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 |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
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