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Intention-to-treat assessment of glecaprevir + pibrentasvir combination therapy for patients with chronic hepatitis C in the real world.

Abstract

AIMS

We assessed the problems and efficacy of glecaprevir + pibrentasvir (GLE/PIB) therapy for patients infected with hepatitis C virus (HCV) in the real world.

METHOD

A total of 423 patients infected with HCV who started treatment at eight different centers in Japan were enrolled in the study. Glecaprevir (300 mg) and pibrentasvir (120 mg) were given once daily for 8 weeks to 246 non-cirrhotic direct-acting antiviral (DAA)-naive patients with HCV genotype (GT)-1 or -2, and for 12 weeks to patients who: were DAA-naive cirrhotic (n = 55), had experienced DAA failure (n = 78), were cirrhotic and had DAA failure (n = 37), and were other GT-1/2 (n = 7). Anti-HCV efficacy was defined as a sustained virologic response 12 weeks post-treatment (SVR12). The evaluation was undertaken in an intention-to-treat (ITT) population and in patients who were assessed at SVR12 (modified ITT population).

RESULTS

In the ITT population, 220 (89%) patients on the 8-week regimen and 164 (93%) patients on the 12-week regimen achieved SVR12. The 30 dropout patients were predominantly men and with GT-2. All other DAA-naive GT-1 patients achieved SVR12. The 12-week regimen resulted in 100% SVR12 in 41 GT-2 patients. Nine patients did not achieve SVR12: two DAA naive with GT-2a, two GT-3b patients, two GT-1 patients with discontinuation, and three other GT-1 patients with a history of DAA failure. Four of seven patients who discontinued treatment due to severe adverse effects were more than 75 years old.

CONCLUSIONS

Glecaprevir + pibrentasvir had a remarkable anti-HCV effect in GT-1 and GT-2 patients, but not in GT-3b patients. Although this therapy was reasonably safe, it is necessary to carefully consider elderly and dropout patients.

Authors+Show Affiliations

Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.Department of Gastroenterology, Showa University, Yokohama, Japan.Department of Gastroenterology, Tokai University, Isehara, Japan.Department of Gastroenterology, Kagawa Prefectural Central Hospital, Takamatsu, Japan.Department of Gastroenterology, Okayama City General Medical Center, Okayama, Japan.Department of Gastroenterology, Okayama University, Okayama, Japan.Aiseikai Yamashina Hospital, Kyoto, Japan.Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.Department of Hepatology, Osaka City University Graduate School of Medicine, Osaka, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31323165

Citation

Tamori, Akihiro, et al. "Intention-to-treat Assessment of Glecaprevir + Pibrentasvir Combination Therapy for Patients With Chronic Hepatitis C in the Real World." Hepatology Research : the Official Journal of the Japan Society of Hepatology, 2019.
Tamori A, Inoue K, Kagawa T, et al. Intention-to-treat assessment of glecaprevir + pibrentasvir combination therapy for patients with chronic hepatitis C in the real world. Hepatol Res. 2019.
Tamori, A., Inoue, K., Kagawa, T., Takaguchi, K., Nouso, K., Iwasaki, Y., ... Kawada, N. (2019). Intention-to-treat assessment of glecaprevir + pibrentasvir combination therapy for patients with chronic hepatitis C in the real world. Hepatology Research : the Official Journal of the Japan Society of Hepatology, doi:10.1111/hepr.13410.
Tamori A, et al. Intention-to-treat Assessment of Glecaprevir + Pibrentasvir Combination Therapy for Patients With Chronic Hepatitis C in the Real World. Hepatol Res. 2019 Jul 19; PubMed PMID: 31323165.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intention-to-treat assessment of glecaprevir + pibrentasvir combination therapy for patients with chronic hepatitis C in the real world. AU - Tamori,Akihiro, AU - Inoue,Kazuaki, AU - Kagawa,Tatehiro, AU - Takaguchi,Koichi, AU - Nouso,Kazuhiro, AU - Iwasaki,Yoshiaki, AU - Minami,Masahito, AU - Hai,Hoang, AU - Enomoto,Masaru, AU - Kawada,Norifumi, Y1 - 2019/07/19/ PY - 2019/04/21/received PY - 2019/06/20/revised PY - 2019/07/11/accepted PY - 2019/7/20/pubmed PY - 2019/7/20/medline PY - 2019/7/20/entrez KW - direct-acting antiviral therapy KW - dropout KW - hepatitis C virus KW - intention-to-treat KW - sustained virologic response JF - Hepatology research : the official journal of the Japan Society of Hepatology JO - Hepatol. Res. N2 - AIMS: We assessed the problems and efficacy of glecaprevir + pibrentasvir (GLE/PIB) therapy for patients infected with hepatitis C virus (HCV) in the real world. METHOD: A total of 423 patients infected with HCV who started treatment at eight different centers in Japan were enrolled in the study. Glecaprevir (300 mg) and pibrentasvir (120 mg) were given once daily for 8 weeks to 246 non-cirrhotic direct-acting antiviral (DAA)-naive patients with HCV genotype (GT)-1 or -2, and for 12 weeks to patients who: were DAA-naive cirrhotic (n = 55), had experienced DAA failure (n = 78), were cirrhotic and had DAA failure (n = 37), and were other GT-1/2 (n = 7). Anti-HCV efficacy was defined as a sustained virologic response 12 weeks post-treatment (SVR12). The evaluation was undertaken in an intention-to-treat (ITT) population and in patients who were assessed at SVR12 (modified ITT population). RESULTS: In the ITT population, 220 (89%) patients on the 8-week regimen and 164 (93%) patients on the 12-week regimen achieved SVR12. The 30 dropout patients were predominantly men and with GT-2. All other DAA-naive GT-1 patients achieved SVR12. The 12-week regimen resulted in 100% SVR12 in 41 GT-2 patients. Nine patients did not achieve SVR12: two DAA naive with GT-2a, two GT-3b patients, two GT-1 patients with discontinuation, and three other GT-1 patients with a history of DAA failure. Four of seven patients who discontinued treatment due to severe adverse effects were more than 75 years old. CONCLUSIONS: Glecaprevir + pibrentasvir had a remarkable anti-HCV effect in GT-1 and GT-2 patients, but not in GT-3b patients. Although this therapy was reasonably safe, it is necessary to carefully consider elderly and dropout patients. SN - 1386-6346 UR - https://www.unboundmedicine.com/medline/citation/31323165/Intention-to-treat_Assessment_of_Glecaprevir_+_Pibrentasvir_Combination_Therapy_for_Patients_with_Chronic_Hepatitis_C_in_the_Real_World L2 - https://doi.org/10.1111/hepr.13410 DB - PRIME DP - Unbound Medicine ER -