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RISS 인기검색어
- 검색키워드
- 저자 : ( Bourlière M ) (검색결과 2 건)
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( Sulkowski M ),( Durand F ),( Reddy Kr ),( Lawitz E ),( Bourlière M ),( Cheinquer N ),( Scherbakovsky S ),( Chokkalingam A ),( Ni L ),( Gaggar A ),( Colombo M ),( Kyung Min K ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Aims: The major metabolite of sofosbuvir (SOF), GS-331007, is cleared renally and tends to accumulate in patients with chronic kidney disease (CKD). However, there are a substantial amount of data showing that this accumulation is not clinically significant, even in patients with end stage renal disease. Methods: This retrospective analysis of 37 Phase 2 and 38 Phase 3 studies presents the safety profile of SOF-based therapies (LDV/SOF, SOF/VEL and SOF/VEL/VOX) in patients with mild to moderate CKD as well as in patients with normal renal function. Results: 8,181 patients were included in this analysis. Mean baseline eGFR was 118.2, 69.3, and 43.6 mL/min/1.73m2 for patients with normal renal function (n=6575), mild (n=1499), or moderate (n=107) renal impairment, respectively. The mean eGFR at post-treatment follow-up week 4 was 114.4, 69.9, and 46.3 mL/min/1.73m2 for patients with normal renal function (n=5519), mild (n=1285), or moderate (n=90) renal impairment, respectively. When comparing baseline levels with those of post-treatment follow-up week 4, there was no clinical difference observed. Baseline characteristics were generally similar across groups, except patients with impaired renal function were older. Table 1 provides a summary of adverse events (AEs). Rates of Grade 3-4 AEs and discontinuations due to AEs were similar across groups. Patients with moderate renal impairment had higher rates of SAEs but most were not treatment-related. Conclusions: Sofosbuvir-based regimens were safe and well-tolerated in patients with mild or moderate renal impairment. Renal function remained stable throughout treatment, and similar rates of AEs were observed across all treatment groups.
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( 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.
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