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This study will evaluate the safety and efficacy of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC)) treatment under real world use in Japan. Among adult patients with chronic genotype 1 hepatitis C virus (HCV) infection and treated with Harvoni 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 |
|---|---|---|---|
| Harvoni | Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harvoni | Drug | Harvoni (90/400 mg) FDC tablet 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 chronic genotype 1 HCV infection with or without compensated cirrhosis who take Harvoni as part of routine clinical care at a participating clinic/hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ageo-shi | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32869924 | Derived | Mizokami M, Liu LJ, Fujiyama N, Littman M, Yuan J, Sekiya T, Hedskog C, Ng LJ. Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan. J Viral Hepat. 2021 Jan;28(1):129-141. doi: 10.1111/jvh.13395. Epub 2020 Sep 16. |
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Whole blood
| Proportion of participants with HCV NS5A and NS5B resistance associated variants among patients who do not achieve SVR at 12 weeks |
| Approximately 12 weeks after treatment completion or discontinuation |
| Akita |
| Japan |
| Amagasaki-shi | Japan |
| Aomori | Japan |
| Arao-shi | Japan |
| Asahi-shi | Japan |
| Asahikawa-shi | Japan |
| Asakura-shi | Japan |
| Bunkyō City | Japan |
| Chiba | Japan |
| Chichibu-shi | Japan |
| Chuo-shi | Japan |
| Fujioka-shi | Japan |
| Fukui-shi | Japan |
| Fukuoka | Japan |
| Gifu | Japan |
| Hakodate-shi | Japan |
| Hamamatsu | Japan |
| Handa-shi | Japan |
| Hashima-shi | Japan |
| Hatsukaichi-shi | Japan |
| Higashiibaraki-gun | Japan |
| Hirosaki-shi | Japan |
| Hiroshima | Japan |
| Hitachi-shi | Japan |
| Hukui-shi | Japan |
| Ichikawa-shi | Japan |
| Iizuka-shi | Japan |
| Ikeda-shi | Japan |
| Inashiki-gun | Japan |
| Inzai-shi | Japan |
| Iruma-gun | Japan |
| Ise-shi | Japan |
| Iwaki | Japan |
| Izumo-shi | Japan |
| Izunokuni-shi | Japan |
| Kagoshima | Japan |
| Kamogawa-shi | Japan |
| Kanazawa | Japan |
| Karatsu-shi | Japan |
| Kashihara-shi | Japan |
| Kashiwa-shi | Japan |
| Kasukabe-shi | Japan |
| Kawagoe-shi | Japan |
| Kawaguchi-shi | Japan |
| Kawasaki-shi | Japan |
| Kirishima-shi | Japan |
| Kitakyushu-shi | Japan |
| Kitamoto-shi | Japan |
| Kobe | Japan |
| Kodaira-shi | Japan |
| Kofu | Japan |
| Komae-shi | Japan |
| Komaki-shi | Japan |
| Koriyama-shi | Japan |
| Koshigaya-shi | Japan |
| Kōtoku | Japan |
| Kuga-gun | Japan |
| Kuki-shi | Japan |
| Kumamoto | Japan |
| Kurashiki-shi | Japan |
| Kure-shi | Japan |
| Kurume-shi | Japan |
| Kyoto | Japan |
| Maebashi | Japan |
| Matsumoto-shi | Japan |
| Matsuyama | Japan |
| Minatoku | Japan |
| Miyazaki | Japan |
| Moriguchi-shi | Japan |
| Morioka | Japan |
| Nagakute-shi | Japan |
| Nagasaki | Japan |
| Nagoya | Japan |
| Nakagami-gun | Japan |
| Nerima-ku | Japan |
| Niigata | Japan |
| Nishinomiya-shi | Japan |
| Noshiro | Japan |
| Obihiro-shi | Japan |
| Ofukeshi | Japan |
| Okayama | Japan |
| Osaka | Japan |
| Osakasayama-shi | Japan |
| Oume-shi | Japan |
| Ōita | Japan |
| Ōmihachiman | Japan |
| Ōta-ku | Japan |
| Ōtsu | Japan |
| Saga | Japan |
| Saitama-shi | Japan |
| Sakaishi | Japan |
| Sano-shi | Japan |
| Sapporo | Japan |
| Sasebo-Shi | Japan |
| Sendai | Japan |
| Shimonoseki-shi | Japan |
| Shimotsuga-gun | Japan |
| Shimotsuke-shi | Japan |
| Shinagawa-ku | Japan |
| Shinjuku-ku | Japan |
| Shirakawa-shi | Japan |
| Shizuoka | Japan |
| Shunan-shi | Japan |
| Sumida-ku | Japan |
| Tagawa-shi | Japan |
| Takamatsu | Japan |
| Takasaki-shi | Japan |
| Toda-shi | Japan |
| Tokorozawa-shi | Japan |
| Tokushima | Japan |
| Tonami-shi | Japan |
| Toyama | Japan |
| Toyoake-shi | Japan |
| Ureshino-shi | Japan |
| Utsunomiya | Japan |
| Wakayama | Japan |
| Yachiyo-shi | Japan |
| Yamagata | Japan |
| Yanagawa-shi | Japan |
| Yatsushiro-shi | Japan |
| Yokkaichi-shi | Japan |
| Yokohama | Japan |
| Yonago-shi | Japan |
| Yoshida-gun | Japan |
| 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 |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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