Sofosbuvir–velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial

Wei, Lai; Lim, Seng Gee; Xie, Qing; Văn, Kính Nguyen; Piratvisuth, Teerha; Huang, Yan; Wu, Shanming; Xu, Ming; Tang, Hong; Cheng, Jun; Manh, Hung Le; Gao, Yanhang; Mou, Zhuangbo; Sobhonslidsuk, Abhasnee; Dou, Xiaguang; Thongsawat, Satawat; Nan, Yuemin; Tan, Chee Kiat; Ning, Qin; Tee, Hoi-Poh; Mao, Yimin; Stamm, Luisa M.; Lu, Sophia; Dvory‐Sobol, Hadas; Mo, Hongmei; Brainard, Diana M.; Yang, Yue; Dao, Long Van; Wang, Guiqiang; Tanwandee, Tawesak; Hu, Peng; Tangkijvanich, Pisit; Zhang, Lunli; Gao, Zhi; Lin, Feng; Le, Thi Tuyet Phuong; Shang, Jia; Gong, Guozhong; Li, Jun; Su, Minghua; Duan, Zhongping; Mohamed, Rosmawati; Hou, Jin; Jia, Jidong

doi:10.1016/s2468-1253(18)30343-1

Cited by 99 publications

(125 citation statements)

References 20 publications

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“…Although we did not have pre‐treatment subgenotyping data for HCV GT 3 patients, one patient was confirmed to have HCV GT 3b infection at the time of relapse. This finding was line with two recent studies showing that the SVR 12 rates of GLE/PIB and SOF/VEL were suboptimal for HCV GT 3b due to the presence of high NS5A resistance‐associated substitution (RAS) rates …”

Section: Discussionsupporting

confidence: 92%

“…This finding was line with two recent studies showing that the SVR 12 rates of GLE/PIB and SOF/VEL were suboptimal for HCV GT 3b due to the presence of high NS5A resistance-associated substitution (RAS) rates. 27,38 Regarding safety, 99.7% of our patients completed the scheduled treatment with one non-cirrhotic patient temporarily stopped treatment for one weeks due to skin lesions and one cirrhotic patient permanently discontinued treatment due to jaundice and hepatitis of unknown aetiology. These events improved after stopping treatment and both patients achieved SVR 12 .…”

Section: Discussionmentioning

confidence: 99%

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Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real‐world effectiveness and safety in Taiwan

Liu

Hung

et al. 2019

Liver International

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Background & Aims Large‐scale data regarding the real‐world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) for patients with chronic hepatitis C virus (HCV) infection were limited in East Asia. We aimed to evaluate the clinical performance of GLE/PIB in different HCV populations in Taiwan. Methods A total of 658 chronic HCV patients with compensated liver diseases receiving GLE/PIB for 8 (n = 549), 12 (n = 103) or 16 (n = 6) weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response at off‐therapy 12 weeks (SVR12). Patient characteristics potentially related to SVR12 and the safety profiles were also assessed. Results By evaluable population (EP) and per‐protocol (PP) analyses, the overall SVR12 rate was 98.2% (95% confidence interval (CI): 96.8%‐99.0%) and 99.4% (95% CI: 98.4%‐99.8%). The SVR12 rates were 98.9% (95% CI: 97.6%‐99.5%), 94.2% (95% CI: 87.9%‐97.3%) and 100% (95% CI: 60.1%‐100%) in patients receiving 8, 12 and 16 weeks of treatment respectively. A total of 656 (99.7%) patients completed the scheduled treatment. The SVR12 rates were comparable regardless of baseline characteristics or week 4 viral decline. Twenty (3.0%) patients had serious adverse events (AEs), but none were not related to GLE/PIB. The two most common AEs were pruritus (7.8%) and fatigue (5.5%). Two (0.3%) and no patients had ≥3‐fold upper limit of normal (ULN) for total bilirubin and alanine aminotransferase (ALT) levels. Conclusions GLE/PIB for 8‐16 weeks is effective and well‐tolerated for patients with chronic HCV infection in Taiwan.

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real‐world effectiveness and safety in Taiwan

Liu

Hung

et al. 2019

Liver International

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“…This high SVR12 rate was driven by genotype 3a − infected patients who had much higher SVR12 (97.2%) than genotype 3b − infected patients (89.3%), particularly with prior treatment experience (57.1%) or presence of cirrhosis (88.2%). This finding was consistent with a recent clinical trial in Asian patients treated with SOF/VEL, which showed that the SVR12 rate among patients with genotype 3b, particularly those with cirrhosis, was lower than that observed in genotype 3a − infected patients [31]. This was due to the higher prevalence of NS5A resistance-associated substitutions at baseline in those with HCV genotype 3b infection [31].…”

Section: Discussionsupporting

confidence: 91%

Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study

Charatcharoenwitthaya

Wongpaitoon

Komolmit

et al. 2020

BMC Gastroenterol

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Background: We investigated real-world effectiveness and safety of sofosbuvir and the nonstructural protein 5A inhibitors in the treatment of patients infected with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, or 6. Methods: We analyzed data from 1021 patients with HCV infection (506 with genotype 1; 16 with genotype 2; 314 with genotype 3; 13 with genotype 4; 166 with genotype 6) who received 12 to 24 weeks of daclatasvir plus sofosbuvir (n = 767), ledipasvir/sofosbuvir (n = 197), or sofosbuvir/velpatasvir (n = 57), with or without ribavirin in 12 centers across Thailand to estimate sustained virologic response at post-treatment week 12 (SVR12). Results: Overall, SVR12 rate was 98.0% (95% confidence interval [CI], 96.7-98.8%) with daclatasvir plus sofosbuvir, 97.9% (95% CI, 94.8-99.2%) with ledipasvir/sofosbuvir, and 96.5% (95% CI, 88.1-99.0%) with sofosbuvir/velpatasvir. SVR12 was achieved by 99.2% (95% CI, 97.9-99.7%) of subjects with genotype 1 infection, 100% (95% CI, 78.5-100%) of those with genotype 2 infection, 96.7% (95% CI, 94.0-98.2%) of those with genotype 3 infection, 90.9% (95% CI, 62.3-98.4%) of those with genotype 4 infection, and 96.7% (95% CI 92.5-98.6%) of those with genotype 6 infection. Patients with advanced liver disease were at risk of treatment failure. Only four patients discontinued treatment before week 4 due to non-hepatic adverse events. Conclusions: In this large cohort of patients with various HCV genotypes managed in the real-world practice setting, daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir achieved high SVR rates with good safety profile, comparable to those observed in clinical trials.

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“…Among them, an SVR rate of 89% in patients without cirrhosis but only 50% in patients with cirrhosis patients was depicted. 7 For the other pangenotypic DAA regimen, glecaprevir (GLE)/pibrentasvir (PIB), an SVR rate of 94.9% could be attained in HCV-3 treatment-naïve patients without cirrhosis who received 8 weeks of treatment in the ENDURANCE-3 study. Among them, the SVR rate of patients with the A30K mutation in NS5A was 75% (12/16) compared to 99% (135/137) in those without the mutation.…”

Section: Hcv-3mentioning

confidence: 99%

Unmet needs of chronic hepatitis C in the era of direct-acting antiviral therapy

Huang

2020

Clin Mol Hepatol

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The treatment of chronic hepatitis C (CHC) has been revolutionized in an era of all-oral direct-acting antivirals (DAAs) since 2014. Satisfactory treatment efficacy and tolerability can be provided by novel DAAs. Nevertheless, there are still some unmet needs and emerging issues in the treatment of CHC in the DAA era. Certain hard-to-cure populations are prone to have inferior treatment responses, including patients with severe liver decompensation, active hepatocellular carcinoma (HCC), and hepatitis C virus (HCV) genotype 3 (HCV-3) infection and those who experience multiple DAA treatment failures. Hepatitis B virus (HBV) reactivation during and after DAA treatment has raised concern regarding the use of prophylactic antivirals against HBV throughout DAA treatment. However, the standard strategy for the use of prophylactic antivirals is not uniform across regional guidelines. In the post-sustained virological response (SVR) period, HCC still occurs in a substantial proportion of patients. Due to the relatively short follow-up period, the net benefit of the achievement of an SVR by DAAs in the reduction of extrahepatic manifestations has not yet been determined. Attention must also be paid to HCV reinfection, particularly in high-risk populations. The most critical and unmet need for HCV elimination is the large gap in the HCV care cascade at the population level. To accomplish the World Health Organization (WHO)’s goal for HCV elimination by 2030, the expansion of access to HCV care requires a continuous effort to overcome practical and political challenges.

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Sofosbuvir–velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial

Cited by 99 publications

References 20 publications

Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real‐world effectiveness and safety in Taiwan

Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real‐world effectiveness and safety in Taiwan

Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study

Unmet needs of chronic hepatitis C in the era of direct-acting antiviral therapy

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