Use-Results Surveillance Study of Harvoni® in Japanese Patients With Chronic Genotype 1 Hepatitis C Virus Infection

NCT02591277 | Completed FDA Drug

• 1 other identifier: GS-US-337-1498
• Study Type: observational
• Target: 3,294
• Locations: 1 country
• Sites: 125

Brief Summary

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.

Conditions

Hepatitis C

Keywords

Hepatitis C virus; observational; post-marketing; ledipasvir/sofosbuvir; Japan

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse drug reaction (ADR) under real world settings

  Up to 16 weeks

Secondary Outcomes (2)

• Proportion of participants with sustained virologic response (SVR) 12 and 24 weeks after discontinuation of therapy (SVR12 and SVR24)

  Posttreatment Weeks 12 and 24

• 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

Study Arms (1)

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.

Drug: Harvoni

Interventions

Harvoni DRUG

Harvoni (90/400 mg) FDC tablet administered orally once daily

Also known as: LDV/SOF, GS-5885/GS-7977

Harvoni

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult patients with chronic genotype 1 HCV infection with or without compensated cirrhosis
• Patients who are prescribed Harvoni

You may not qualify if:

• None

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (125)

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Ageo-shi, Japan

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Akita, Japan

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Amagasaki-shi, Japan

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Aomori, Japan

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Arao-shi, Japan

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Asahi-shi, Japan

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Asahikawa-shi, Japan

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Asakura-shi, Japan

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Bunkyō City, Japan

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Chiba, Japan

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Chichibu-shi, Japan

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Chuo-shi, Japan

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Fujioka-shi, Japan

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Fukui-shi, Japan

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Fukuoka, Japan

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Gifu, Japan

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Hakodate-shi, Japan

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Hamamatsu, Japan

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Handa-shi, Japan

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Hashima-shi, Japan

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Hatsukaichi-shi, Japan

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Higashiibaraki-gun, Japan

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Hirosaki-shi, Japan

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Hiroshima, Japan

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Hitachi-shi, Japan

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Hukui-shi, Japan

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Ichikawa-shi, Japan

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Iizuka-shi, Japan

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Ikeda-shi, Japan

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Inashiki-gun, Japan

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Inzai-shi, Japan

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Iruma-gun, Japan

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Ise-shi, Japan

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Iwaki, Japan

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Izumo-shi, Japan

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Izunokuni-shi, Japan

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Kagoshima, Japan

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Kamogawa-shi, Japan

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Kanazawa, Japan

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Karatsu-shi, Japan

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Kashihara-shi, Japan

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Kashiwa-shi, Japan

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Kasukabe-shi, Japan

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Kawagoe-shi, Japan

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Kawaguchi-shi, Japan

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Kawasaki-shi, Japan

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Kirishima-shi, Japan

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Kitakyushu-shi, Japan

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Kitamoto-shi, Japan

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Kobe, Japan

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Kodaira-shi, Japan

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Kofu, Japan

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Komae-shi, Japan

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Komaki-shi, Japan

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Koriyama-shi, Japan

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Koshigaya-shi, Japan

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Kōtoku, Japan

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Kuga-gun, Japan

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Kuki-shi, Japan

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Kumamoto, Japan

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Kurashiki-shi, Japan

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Kure-shi, Japan

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Kurume-shi, Japan

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Kyoto, Japan

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Maebashi, Japan

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Matsumoto-shi, Japan

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Matsuyama, Japan

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Minatoku, Japan

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Miyazaki, Japan

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Moriguchi-shi, Japan

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Morioka, Japan

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Nagakute-shi, Japan

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Nagasaki, Japan

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Nagoya, Japan

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Nakagami-gun, Japan

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Nerima-ku, Japan

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Niigata, Japan

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Nishinomiya-shi, Japan

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Noshiro, Japan

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Obihiro-shi, Japan

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Ofukeshi, Japan

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Okayama, Japan

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Osaka, Japan

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Osakasayama-shi, Japan

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Oume-shi, Japan

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Ōita, Japan

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Ōmihachiman, Japan

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Ōta-ku, Japan

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Ōtsu, Japan

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Saga, Japan

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Saitama-shi, Japan

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Sakaishi, Japan

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Sano-shi, Japan

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Sapporo, Japan

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Sasebo-Shi, Japan

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Sendai, Japan

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Shimonoseki-shi, Japan

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Shimotsuga-gun, Japan

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Shimotsuke-shi, Japan

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Shinagawa-ku, Japan

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Shinjuku-ku, Japan

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Shirakawa-shi, Japan

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Shizuoka, Japan

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Shunan-shi, Japan

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Sumida-ku, Japan

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Tagawa-shi, Japan

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Takamatsu, Japan

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Takasaki-shi, Japan

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Toda-shi, Japan

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Tokorozawa-shi, Japan

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Tokushima, Japan

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Tonami-shi, Japan

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Toyama, Japan

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Toyoake-shi, Japan

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Ureshino-shi, Japan

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Utsunomiya, Japan

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Wakayama, Japan

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Yachiyo-shi, Japan

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Yamagata, Japan

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Yanagawa-shi, Japan

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Yatsushiro-shi, Japan

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Yokkaichi-shi, Japan

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Yokohama, Japan

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Yonago-shi, Japan

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Yoshida-gun, Japan

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Related Publications (1)

• 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.

  PMID: 32869924 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Hepatitis C

Interventions

ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2015
• First Posted: October 29, 2015
• Study Start: November 30, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

JP (125)