Glecaprevir–pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies—a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2)

Wei, Lai; Wang, Guiqiang; Alami, Negar N.; Xie, Wen; Heo, Jeong; Xie, Qing; Zhang, Mingxiang; Kim, Yoon Jun; Lim, Seng Gee; Fredrick, Linda; Lü, Wenjing; Liu, Wei; Kalluri, Hari V.; Krishnan, Preethi; Tripathi, Rakesh; Mobashery, N.; Burroughs, Margaret; Asatryan, Armen; Jia, Jidong; Hou, Jinlin

doi:10.1016/s2468-1253(20)30086-8

Cited by 40 publications

(57 citation statements)

References 15 publications

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“…Both the GLE/PIB and SOF/VEL groups exhibited excellent SVR12 rates regardless of baseline patient characteristics. This result was comparable to previous pooled analyses and other real-world reports [19][20][21][22][23][24].…”

Section: Discussionsupporting

confidence: 91%

“…In this real-world setting involving a south Taiwanese cohort, our study revealed that the overall SVR12 rates in the GLE/PIB and SOF/VEL groups were 95.7% and 94.6%, respectively by EP analysis and 98.9% and 99.5%, respectively by PP analysis. This therapeutic e cacy was similar to those reported in previous clinical trials, meta-analyses, and real-world reports for GLE/PIB [10][11][12][19][20][21] and SOF/VEL [14][15][16][17][22][23][24]. The real-world data currently available mainly involve the effects of a single drug.…”

Section: Discussionsupporting

confidence: 88%

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Real-World Efficacy and Safety of Pangenotypic Direct-Acting Antivirals Against Hepatitis C Virus Infection in Taiwan

Chang

Tung

Wei

et al. 2021

Preprint

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Background/Purpose of StudyClinical trials have demonstrated excellent efficacy and safety of pangenotypic direct-acting antivirals (DAAs) for the treatment of hepatitis C virus (HCV). However, there are limited large-scale real-world data on these pangenotypic DAAs. This study examined the results of two pangenotypic regimens, glecaprevir/pibrentasvir (GLE/PIB) and sofosbuvir/velpatasvir (SOF/VEL), in a real-world setting in Taiwan.MethodsAll HCV patients treated with GLE/PIB or SOF/VEL from August 2018 to April 2020 at the Chiayi Chang Gung Memorial Hospital were included. The primary end point was sustained virologic response 12 weeks after treatment cessation (SVR12). Adverse events (AEs) were also reported.ResultsA total of 1 356 HCV patients received pangenotypic DAA treatment during the study period: 742 patients received GLE/PIB and 614 received SOF/VEL. The rates of SVR12 for GLE/PIB and SOF/VEL were 710/718 (98.9%) and 581/584 (99.5%), respectively, by per-protocol analysis, and 710/742 (95.7%) and 581/614 (94.6%), respectively, by evaluable population analysis. Eleven patients (GLE/PIB: 8, SOF/VEL: 3) did not achieve SVR12. The most common AEs for GLE/PIB and SOF/VEL were pruritus (17.4% vs. 2.9%), abdominal discomfort (5.8% vs. 4.4 %), dizziness (4.2% vs. 2%), and malaise (3.1% vs. 2.9%). Laboratory abnormalities were uncommon, with <1% of patients exhibiting elevated total bilirubin or aminotransferase levels with both regimens. There were five drug discontinuations owing to AEs (bilirubin elevation: 3, dermatological issues: 2).ConclusionIn real-world practice, the pangenotypic DAAs GLE/PIB and SOF/VEL are effective and well tolerated, achieving high SVR12 rates for patients with all HCV genotypes.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 88%

Real-World Efficacy and Safety of Pangenotypic Direct-Acting Antivirals Against Hepatitis C Virus Infection in Taiwan

Chang

Tung

Wei

et al. 2021

Preprint

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“… 1 , 3 , 4 The regimen is also recommended by AASLD as a first-line treatment for treatment-naïve patients and as an alternative for PegIFN+RBV-experienced patients. 2 Recent clinical data showed that with 8 weeks of GLE/PIB in non-cirrhotic patients, a lower SVR12 rate was observed in GT3b-infected patients than in GT3a-infected patients, 30 indicating that 8 weeks is not an optimal course in the former group. Additionally, SOF+DCV is recognized only by the WHO as a first-line regimen in non-cirrhotic, GT3-infected patients.…”

Section: Treatment Recommendations For Gt3-infected Patientsmentioning

confidence: 99%

“…1 , 2 ). 30 , 42 – 44 It should be noted that no head-to head clinical trials between these regimens have been conducted among Chinese GT3-infected patients.…”

Section: Clinical Data For Daas In Gt3-infected Patientsmentioning

confidence: 99%

Direct-acting Antiviral Regimens for Patients with Chronic Infection of Hepatitis C Virus Genotype 3 in China

Wang

Wei

2021

Journal of Clinical and Translational Hepatology

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“…19 However, there are currently no data on the efficacy and safety of the G/P regimen in Korean subjects with HCV infection. Five phase II and III clinical trials of G/P therapy, including three global trials (ENDURANCE 1 20 and 2 21 and SURVEYOR II [part 4] 21 ) and two Asian clinical trials (VOYAGE I 22 and II 22 ), enrolled patients from South Korea. Therefore, using pooled data from these five clinical trials, this analysis aimed to evaluate the efficacy and safety of G/P in Korean patients with GT1 or GT2 HCV infection with or without compensated cirrhosis.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials

et al. 2021

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Background/Aims: Glecaprevir/pibrentasvir (G/P) is the first pan-genotypic direct-acting antiviral combination therapy approved in Korea. An integrated analysis of five phase II and III trials was conducted to evaluate the efficacy and safety of G/P in Korean patients with chronic hepatitis C virus (HCV) infection. Methods:The study analyzed pooled data on Korean patients with HCV infection enrolled in the ENDURANCE 1 and 2, SURVEYOR II part 4 and VOYAGE I and II trials, which evaluated the efficacy and safety of 8 or 12 weeks of G/P treatment. The patients were either treatment-naïve or had received sofosbuvir or interferon-based treatment. Efficacy was evaluated by assessing the rate of sustained virologic response at 12 weeks posttreatment (SVR12). Safety was evaluated by monitoring adverse events (AEs) and laboratory assessments. Results:The analysis included 265 patients; 179 (67.5%) were HCV treatment-naïve, and most patients were either subgenotype 1B (48.7%) or 2A (44.5%). In the intention-to-treat population, 262 patients (98.9%) achieved SVR12. Three patients did not achieve SVR12: one had virologic failure and two had non-virologic failures. Most AEs were grade 1/2; eight patients (3.0%) experienced at least one grade ≥3 AE. No serious AEs related to G/P treatment were reported, and grade ≥3 hepatic laboratory abnormalities were rare (0.8%).Conclusions: G/P therapy was highly efficacious and well tolerated in Korean patients with HCV infection, with most patients achieving SVR12. The safety profile was comparable to that observed in a pooled analysis of a global pan-genotypic population of patients with HCV infection who received G/P.

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Glecaprevir–pibrentasvir to treat chronic hepatitis C virus infection in Asia: two multicentre, phase 3 studies—a randomised, double-blind study (VOYAGE-1) and an open-label, single-arm study (VOYAGE-2)

Cited by 40 publications

References 15 publications

Real-World Efficacy and Safety of Pangenotypic Direct-Acting Antivirals Against Hepatitis C Virus Infection in Taiwan

Real-World Efficacy and Safety of Pangenotypic Direct-Acting Antivirals Against Hepatitis C Virus Infection in Taiwan

Direct-acting Antiviral Regimens for Patients with Chronic Infection of Hepatitis C Virus Genotype 3 in China

Efficacy and Safety of Glecaprevir/Pibrentasvir in Korean Patients with Chronic Hepatitis C: A Pooled Analysis of Five Phase II/III Trials

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