http://chineseinput.net/에서 pinyin(병음)방식으로 중국어를 변환할 수 있습니다.
변환된 중국어를 복사하여 사용하시면 됩니다.
- 中文 을 입력하시려면 zhongwen을 입력하시고 space를누르시면됩니다.
- 北京 을 입력하시려면 beijing을 입력하시고 space를 누르시면 됩니다.
RISS 인기검색어
- 검색키워드
- 저자 : ( Philippe J Zamor ) (검색결과 1 건)
- 무료
- 기관 내 무료
- 유료
-
An Integrated Analysis of the Efficacy of Glecaparevir/ Pibrentasvir by Geographical Region
( Edward Gane ),( Kazuaki Chayama ),( Mudra Kapoor ),( Stuart K Roberts ),( Jeong Heo ),( Jia-horng Kao ),( Thomas Berg ),( Philippe J Zamor ),( Brian Conway ),( James Park ),( Sandra S Lovell ),( Rak 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1
Aims: The pangenotypic direct-acting antiviral (DAA) regimen glecaprevir (developed by AbbVie and Enanta) coformulated with pibrentasvir (G/P) is approved in the US, EU, and Japan to treat chronic HCV genotype (GT) 1-6 infection. In the US and EU, G/P is indicated for treatment-naïve, HCV genotype (GT) 1-6-infected patients without and with compensated cirrhosis for 8-week and 12-week treatment durations, respectively, and achieved SVR12 rates ≥95% across all six major GTs. In clinical studies, G/P exposures were similar across ethnicities; an inte grated analysis of the efficacy of G/P by geographical region was conducted to assess the impact of geography and ethnicity on SVR12. Methods: Data were pooled from 9 phase 2 and 3 clinical stud ies; data from 2 additional phase 3 clinical studies conducted in Japan were pooled separately. Patients had HCV GT1-6 in fection with or without compensated cirrhosis and were either HCV treatment-naïve or experienced with interferon (IFN) or pe gIFN with or without ribavirin (RBV), sofosbuvir and RBV with or without pegIFN, or NS5A- and/or protease inhibitor-containing regimens. G/P (300 mg/120 mg) was orally dosed once-daily for 8, 12, or 16 weeks. The primary efficacy endpoint in all studies was SVR12. Safety and tolerability were assessed in all patients. Data from all 11 studies will be pooled for presentation. Results: In total, 2369 patients were included in the integrated analysis: 964 (41%) were enrolled in North America, 891 (38%) in Europe, and 514 (22%) enrolled and pooled from Taiwan, Korea, Australia, New Zealand, Chile, Israel, and South Africa; 332 additional patients were enrolled in Japan. The SVR12 results by region were 97% (935/964; 95% CI 95.9-98.1), 98% (876/891; 95% CI 97.5-99.1), and 96% (496/514; 95% CI 94.9-98.1) for patients enrolled in North America, Europe, and the other pooled countries, respectively. Patients enrolled in Japan achieved a 98% (325/332; 95% CI 95.7-99.0) SVR12 rate. Less than 1% of all patients had virologic failure. G/P was well-tolerated with a favorable safety profile; treatment dis continuations due to adverse events and cases of drug-induced liver injury were rare (<1%). Conclusions: G/P efficacy, safety and tolerability were consis tently favorable regardless of baseline characteristics, suggest ing that recently updated HCV treatment guidelines for the use of G/P in clinical practice can be applied to all ethnicities and geographical regions, without need for modification.
연관 검색어 추천
이 검색어로 많이 본 자료
활용도 높은 자료
