Safety and Efficacy of Elbasvir/Grazoprevir in Asian Participants with Hepatitis C Virus Genotypes 1 and 4 Infection

( Wei Lai ),( Hiromitsu Kumada ),( Ponni Perumalswami ),( Tawesak Tanwandee ),( Wendy Cheng ),( Jeong Heo ),( Pin Nan Cheng ),( Peggy Hwang ),( Sheng Mei Mu ),( Xu Min Zhao ),( Michael Robertson ),( B 대한간학회 2018 춘·추계 학술대회 (KASL) Vol.2018 No.1

Aims: Clinical experience with direct-acting antiviral treatments for hepatitis C virus (HCV) infection is emerging in the Asia-Pacific region. We conducted an integrated analysis of the safety and efficacy of elbasvir (EBR)/grazoprevir (GZR) in self-identified Asian participants who were enrolled in 11 EBR/GZR phase 2/3 studies. Methods: All participants received EBR/GZR 50 mg/100 mg alone for 12 weeks or in combination with ribavirin (RBV) for 16 weeks. The primary endpoint of all studies was sustained virologic response (HCV RNA < 15 IU/mL) 12 weeks after end of therapy (SVR12). Results: A total of 780 Asian participants with HCV GT1 or 4 infection were included (GT1b, n=715; GT1non-b, n=63; GT4, n=2). Most participants were enrolled from Japan (n=366, 46.9%), mainland China (n=146, 18.7%), Taiwan (n=109, 14.0%) and South Korea (n=90, 11.5%). Overall, 12.4% of participants had cirrhosis, and 20.4% were treatment-experienced. SVR12 was achieved by 756/780 (96.9%, 95% CI 95.5-98.0) of all Asian participants, including 748/772 (96.9%, 95% CI 95.4- 98.0) who received EBR/GZR for 12 weeks and 8/8 (100%, 95% CI 63.1-100.0) who received EBR/GZR + RBV for 16 weeks. The frequency of safety events among Asian participants was: any adverse event (AE), 58.1% (453/780), drug-related AEs, 23.6% (184/780), serious AEs, 2.6% (20/780), and discontinuation due to an AE, 0.9% (7/780). Fifteen participants (1.9%) had elevated ALT/AST levels that met the criteria for an event of clinical interest (ALT/AST >3× baseline and >100 U/L), 3 of whom discontinued treatment. The efficacy and safety profile of EBR/GZR was comparable to that observed among non-Asians. Conclusions: The combination of EBR/GZR was safe and highly effective in this large population of Asian participants with primarily HCV GT1b infection. Late transaminase elevations were reported in approximately 2% of participants, which is consistent with the safety profile of EBR/GZR in non-Asians.

Real-world Treatment Patterns, Outcomes, and Healthcare Resource Utilization in Newly Treated Korean Patients With Asthma: A Retrospective Cohort Study

Choi Nam-Kyong,Shantakumar Sumitra,Kim Mi-Sook,Lee Chang-Hoon,Cheng Wendy Y,Bobbili Priyanka,Yang Bo Ram,Lee Joongyub,Hinds David,Duh Mei Sheng,Korves Caroline,Park Heung-Woo 대한천식알레르기학회 2022 Allergy, Asthma & Immunology Research Vol.14 No.2

Purpose: Although asthma treatment guidelines recommend regular inhaled medication, real-world treatment patterns and outcomes in South Korea have not been examined. We examined real-world treatment patterns and outcomes among patients treated for asthma in South Korea. Methods: This retrospective cohort study utilized data from the South Korean National Health Insurance database (2013–2016). Newly treated patients with asthma aged ≥18 years without history of chronic obstructive pulmonary disease were included. Initial and maintenance medication prescriptions were examined. Treatment discontinuation and switch were described. Asthma exacerbation rates, poor asthma control, and healthcare resource utilization (HRU) were compared between maintenance treatment groups (inhaled versus oral) using adjusted incidence rate ratios (aIRR) and hazard ratios (aHR). Results: Overall, 1,054,707 patients initiated any asthma medication; 37,868 patients initiated inhaled (n = 9,983, 26.4%) or oral (n = 27,885, 73.6%) maintenance medication. More patients initiating inhaled versus oral asthma medication discontinued treatment within 12 months (94.4% vs. 86.3%; P < 0.0001). Patients treated with inhaled and oral medication switched treatment (2.5% and 2.3%; P = 0.4160, respectively). Patients initiating inhaled medication had significantly lower rates of asthma exacerbation (aIRR, 0.52; 95% CI, 0.39–0.69), lack of asthma control (aHR, 0.55; 95% CI, 0.48–0.62; P < 0.0001), all-cause and asthma-related HRU versus oral medication. Conclusions: Despite current asthma guidelines, more patients in South Korea were prescribed oral than inhaled medications, resulting in suboptimal asthma management and increased HRU. This study highlights the need to reduce oral corticosteroid prescriptions for optimized treatment in asthma management.

Long-Term Effectiveness and Safety of Dutasteride versus Finasteride in Patients with Male Androgenic Alopecia in South Korea: A Multicentre Chart Review Study

최광성,심우영,강훈,허창훈,이양원,Sumitra Shantakumar,Yu-Fan Ho,Eun-Jeong Oh,Mei Sheng Duh,Wendy Y. Cheng,Priyanka Bobbili,Philippe Thompson-Leduc,Gary Ong 대한피부과학회 2022 Annals of Dermatology Vol.34 No.5

Background: Dutasteride improves hair growth compared with finasteride in maleandrogenic alopecia (AGA) and is well tolerated. However, real-world evidence for longtermdutasteride use in AGA is lacking. Objective: To describe baseline characteristics, treatment patterns and long-term safety andeffectiveness of dutasteride versus finasteride. Methods: This was a multicentre, retrospective medical chart review study conductedin South Korea. The index date was the first prescription of dutasteride or finasteride. Baseline characteristics were assessed 6 months prior to index. Safety and effectiveness(improvements in basic and specific [BASP] classification) data were collected from indexthroughout the observation period. Results: Overall, 600 male adult patients were included (dutasteride, n=295; finasteride,n=305). Dutasteride-treated patients were older (p<0.001) and more likely to have moderate/severe BASP classification at baseline (p=0.010) compared with finasteride-treated patients. Among patients treated with recommended, on-label dosing exclusively (n=535: dutasteride,n=250; finasteride, n=285), dutasteride-treated patients showed greater improvementin hair growth than finasteride-treated patients, as measured by the BASP basic M classification(adjusted incidence rate ratio [95% confidence interval]: 2.06 [1.08, 3.95]; p=0.029). Among this same subset, overall occurrence of adverse events (AEs) during the observationperiod were not statistically equivalent between groups (dutasteride 7.6%, finasteride 10.5%;p=0.201), although reports of AEs of special interest were equivalent (p<0.001). Conclusion: Dutasteride showed greater effectiveness than finasteride in improving BASP classificationin treating male AGA and had a similar or possibly lower occurrence of overall AEs. Dutasteride may provide an effective and safe treatment option for male patients with AGA.

High Efficacy in Patients with Chronic Hepatitis C Virus (HCV) Genotype (GT)1b Infection Treatment with Elbasvir/Grazo-previr for 12 Weeks: An Integrated Analysis

( Do Young Kim ),( Won Young Tak ),( Stefan Zeuzem ),( Lawrence Serfaty ),( John M. Vierling ),( Wendy Cheng ),( Jacob George ),( Jan Sperl ),( Simone I. Strasser ),( Hiromitsu Kumada ),( Peggy Hwang 대한간학회 2017 춘·추계 학술대회 (KASL) Vol.2017 No.1

Aims: GT1b is the most common HCV genotype globally, accounting for the largest proportion of infections in Europe, Latin America, Russia, Turkey, and East Asia. We report the efficacy of 12 weeks of once-daily elbasvir/grazoprevir (50 mg/100 mg) (NS5A inhibitor/ NS3/4 protease inhibitor) in HCV GT1b-infected patients enrolled in the clinical development program. Methods: This analysis of treatment-naïve and treatment-experienced GT1b-infected patients used data pooled from 11 trials involving 30 countries and included 1070 patients with/without cirrhosis, chronic kidney disease (CKD), and HIV co-infection. Cirrhosis (F4, compensated) was confirmed by either liver biopsy or noninvasive tests. Patients with Stage 4 or Stage 5 CKD on hemodialysis were included. HIV/HCV co-infected patients were required to be on a stable antiretroviral regimen (ARV) (tenofovir or abacavir, emtricitabine or lamivudine, and either raltegrevir, dolutegravir, or rilpivirine) with CD4 >200/μL and HIV viral load undetectable, or if not on ARVs, have CD4 >500/μL and viral load < 50,000 IU/mL. The primary endpoint was the proportion of patients with HCV RNA below the lower limit of quantitation 12 weeks after treatment (SVR12). Efficacy data are presented for the full analysis set (FAS), which includes all patients who received at least one dose of study medication, and for the per-protocol (PP) population, which excludes nonvirologic failures. Results: A total of 1,070 patients were included in the analysis. Mean patient age was 53.7 years (range, 19-80); 50% were male; 47% were white, 43% were Asian, and 9% were black or African American; 20% were treatment-experienced; 39% had a baseline viral load >2,000,000 IU/mL; and 18% had evidence of cirrhosis. SVR12 was 97% (1040/1070) in the FAS; 15 patients (1.4%) were categorized as virologic failures and 15 (1.4%) were categorized as nonvirologic failures (lost-to-follow-up or withdrawal). Excluding the nonvirologic failures, SVR12 was 99% (1040/1055) in the PP analysis. There were no notable differences in subgroup analyses: SVR12 was 97% in both treatment-naïve and treatment-experienced patients; 99% in cirrhotics and 97% in noncirrhotics; 98% in patients with a baseline viral load < 2,000,000 IU/mL and 97% in patients with a baseline viral >2,000,000 IU/mL; 94% in HIV/HCV co-infected patients; and 100% and 95% in patients with Stage 4 or 5 CKD, respectively. Conclusions: High efficacy was achieved in the GT1b-infected population treated with elbasvir/grazoprevir for 12 weeks, with comparable efficacy across subgroups, including those with cirrhosis, high baseline viral load, and prior treatment failures.

Long term effectiveness and safety of dutasteride and finasteride in patients with androgenic alopecia in South Korea

( Gwang Seong Choi ),( Woo Young Sim ),( Hoon Kang ),( Chang Hun Huh ),( Yang Won Lee ),( Sumitra Shantakumar ),( Yu Fan Ho ),( Eun Jeong Oh ),( Mei Sheng Duh ),( Wendy Y. Cheng ),( Priyanka J. Bobbil 대한피부과학회 2020 대한피부과학회 학술발표대회집 Vol.72 No.1

Background: 5α-reductase inhibitors are commonly prescribed for treatment of male androgenic alopecia (AGA). Objectives: To evaluate the long-term effectiveness and occurrence of adverse events (AEs) in AGA patients receiving dutasteride or finasteride. Methods: A retrospective medical chart review study was conducted across 5 hospital-based dermatology clinics in South Korea between Jan 2010 and Dec 2018. Males aged ≥ 18 years at initiation of dutasteride or finasteride for the treatment of AGA (index date) with ≥ 3 years of available follow-up information were included. Results: 295 (49%) and 305 (51%) AGA patients were prescribed dutasteride and finasteride respectively. Dutasteride patients were older and had higher severity at index than finasteride patients. During follow-up, improvement in hair growth was more frequently observed in dutasteride patients, as measured by improvements in BASP for the basic M and specific V types (adjusted IRR = 1.84 [p=0.031] and 1.95 [p=0.019], respectively). Proportions of AEs were equivalent (equivalence margin ±5%) or sometimes lower among dutasteride patients, including AEs of special interest (e.g., decreased libido, erectile dysfunction and ejaculation disorder, proportion difference = 0.7%). Conclusion: Over an observation period of 3 years, dutasteride demonstrated greater effectiveness than finasteride among men with the most common type of AGA (M type) across severity levels. Similar AE frequencies were observed across both drugs.