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1
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
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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 integrated 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 studies; data from 2 additional phase 3 clinical studies conducted in Japan were pooled separately. Patients had HCV GT1-6 infection with or without compensated cirrhosis and were either HCV treatment-naïve or experienced with interferon (IFN) or pegIFN 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 discontinuations due to adverse events and cases of drug-induced liver injury were rare (<1%). Conclusions: G/P efficacy, safety and tolerability were consistently favorable regardless of baseline characteristics, suggesting 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.
2
Distribution of injected fat-soluble vitamins in plasma and tissues of nursery pigs

Jang Young Dal,Rotering Mikayla J.,Isensee Paige K.,Rinholen Kirsten A.,Boston-Denton Carli J.,Kelley Paige G.,Stuart Robert L. 아세아·태평양축산학회 2020 Animal Bioscience Vol.33 No.12
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  ScienceON
  
  KCI
Objective: The objective of this experiment was to investigate the effects of fat-soluble vitamin injection on plasma and tissue vitamin status in nursery pigs. Methods: A total of 16 pigs (initial body weight: 7.15±1.1 kg) were allotted to 2 treatments at d 7 post-weaning. Pigs were fed a corn-soybean meal-based basal diet with no supplemental vitamin A and i.m. injected with 300,000 IU of retinyl palmitate, 900 IU of d-α-tocopherol and 30,000 IU of vitamin D3 with control pigs having no vitamin injection. Blood (d 0, 3, 7, and 14 post-injection) and tissue samples (liver, brain, heart, lung, and muscle; d 7 and 14 post-injection) were collected from pigs. Retinyl palmitate, retinol, and α-tocopherol concentrations were analyzed in plasma and tissues, while plasma was assayed for 25-hydroxycholecalciferol (25-OHD3). Results: Plasma retinol and 25-OHD3 concentrations increased by the vitamin injection from d 3 to 14 post-injection (p<0.05) whereas plasma retinyl palmitate was detected only in the vitamin treatment at d 3 and 7 post-injection (115.51 and 4.97 μg/mL, respectively). Liver retinol, retinyl palmitate, and retinol+retinyl palmitate concentrations increased by retinyl palmitate injection at d 7 and 14 post-injection (p<0.05) whereas those were not detected in the other tissues. The d-α-tocopherol injection increased α-tocopherol concentrations in plasma at d 3 and 7 post-injection (p<0.05) and in liver, heart (p<0.10), and muscle (p<0.05) at d 7 post-injection. Conclusion: Fat-soluble vitamin injection increased plasma status of α-tocopherol, retinol, retinyl palmitate and 25-OHD3. As plasma levels decreased post-injection, vitamin A level in liver and vitamin E level in muscle, heart and liver increased. The α-tocopherol found in plasma after injection was distributed to various tissues but retinyl palmitate only to the liver.
3
The Safety and Tolerability of SOF/VEL/VOX for 8/12 Weeks in >1,000 Patients Treated in the POLARIS Studies: An Integrated Analysis

( 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
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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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