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 : ( Bernard Willems ) (검색결과 2 건)
- 무료
- 기관 내 무료
- 유료
-
( Michael Manns ),( Edward J. Gane ),( Bernard E. Willems ),( Stuart K. Roberts ),( Steven Flamm ),( Marc Bourlière ),( Tarik Asselah ),( Laurent Alric ),( Sunjin Hwang ),( Robert H. Hyland ),( Luisa 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1
Aims: The once-daily fixed-dose combination tablet of sofosbuvir/ velpatasvir/voxilaprevir (SOF/VEL/VOX) was evaluated for the treatment of genotype 1-6 HCV patients with and without compensated cirrhosis. Treatment was for 12 weeks for DAA-experienced patients (POLARIS-1 and POLARIS-4) and for 8 weeks for DAA-naive patients (POLARIS-2 and POLARIS-3). This analysis describes the safety of these 4 Phase 3 studies. Methods: Treatment-emergent adverse events (AEs) and laboratory abnormalities were assessed in patients who received SOF/VEL/VOX or placebo for 12 weeks(POLARIS-1), SOF/VEL/VOX or SOF/VEL for 12 weeks(POLARIS-4), or SOF/VEL/VOX for 8 weeks or SOF/VEL for 12 weeks(POLARIS-2 and POLARIS-3). SAEs and deaths were followed until post-treatment Week 24. Results: 1056 patients were treated with SOF/VEL/VOX for 8 (n=611) or 12 (n=445) weeks, 700 received SOF/VEL for 12 weeks, and 152 received placebo. 38% had compensated cirrhosis, 28% had a BMI ≥30 kg/m2, 36% were female, and 12% were ≥65 years old. Two deaths were reported, one illicit drug overdose and one attributed to hypertension, neither were related to treatment. SAEs and discontinuations were more frequent in the placebo group and occurred with similar frequency in the other groups; none were related to study treatment. Headache, fatigue, nausea, and diarrhea were the most common AEs. Mild diarrhea and nausea occurred more frequently in the SOF/VEL/VOX groups. Overall, 5.1 - 6.6% of patients who received SOF/VEL/VOX or SOF/VEL had Grade 3 or 4 laboratory abnormalities. Among patients receiving VOX, one patient each had a Grade 3 elevation in ALT and bilirubin. Conclusions: SOF/VEL/VOX for 8 or 12 weeks in the POLARIS studies was well tolerated with a low frequency of Grade 3 or 4 AEs, SAEs, and AEs leading to discontinuation. The frequency of AEs in the SOF/VEL/VOX groups was similar to SOF/VEL and placebo groups, with higher rates of mild diarrhea and nausea compared to SOF/VEL.
-
( Beat Müllhaupt ),( Paul Kwo ),( Kosh Agarwal ),( Christophe Duvoux ),( Francois Durand ),( Marcus Peck-Radosavljevic ),( Eric M. Yoshida ),( Leslie Lilly ),( Bernard Willems ),( Hugo Vargas ),( Prin 대한간학회 2016 춘·추계 학술대회 (KASL) Vol.2016 No.1
Aims: The aim of this analysis is to evaluate outcomes in patients who underwent liver transplant after initiating treatment with ledipasvir (LDV)/sofosbuvir (SOF)+ribavirin (RBV) in the SOLAR-1 and SOLAR-2 trials. Methods: We combined data from the SOLAR-1 and SOLAR-2 studies, in which 7 groups of patients with HCV genotype (GT) 1 or 4 were randomized to receive 12 or 24 weeks of LDV/SOF+ RBV: patients without a transplant with 1) Child-Pugh-Turcotte (CPT) B or 2) CPT C cirrhosis; or transplanted patients with 3) no cirrhosis (F0 to F3), 4) CPT A, 5) CPT B or, 6) CPT C cirrhosis, or 7) fibrosing cholestatic hepatitis. Results: Seventeen patients underwent liver transplantation during the study. For all but one patient, this was the first liver transplant. Six were CPT B at screening (5 Group 1, 1 Group 5) and 11 were CPT C (Group 2). Median baseline MELD score was 17 (range 7-23), with the majority (11/17) having scores ≥15. Seven patients underwent transplant prior to completing their full course of treatment. All patients were HCV RNA <LLOQ at the time of liver transplant. All but one patient (94%, 16/17) maintained virologic response 12 weeks after transplant (pTVR12). All patients who achieved pTVR12 received at least 11 weeks of LDV/SOF+RBV. The one patient who did not achieve pTVR12 discontinued study drug on day 21 and underwent liver transplant the following day. Conclusions: Few patients with decompensated cirrhosis treated in the SOLAR studies underwent liver transplantation after initiating LDV/SOF+RBV therapy. For the 17 who did undergo transplant, 94% achieved pTVR12. The data suggest that 11 weeks of treatment prior to transplantation can prevent reinfection of the graft. Future studies are needed to assess the optimal timing and length of treatment in the peri-transplant setting.
연관 검색어 추천
이 검색어로 많이 본 자료
활용도 높은 자료
