Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection

Liu, Chen–Hua; Sun, Hsin‐Yun; Liu, Chun‐Jen; Sheng, Wang‐Huei; Hsieh, Song-Chou; Lo, Yi‐Chun; Liu, W.-C.; Su, Tung‐Hung; Yang, Hung‐Chih; Hong, Chun‐Ming; Tseng, Tai Chung; Chen, P.-J.; Chen, D.-S.; Hung, Chien‐Ching; Kao, Jia‐Horng

doi:10.1111/apt.14647

Cited by 25 publications

(20 citation statements)

References 42 publications

(57 reference statements)

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“…Omar et al (2018) showed that among 18,378 patients with HCV-G4 treated within the Egyptian national program with generic SOF-DCV, the SVR rate was 95.1%. Similar high SVR rates were presented in other reports for SOF-LDV (Zeng et al, 2017;Gupta et al, 2018), and for SOF-Velpatasvir (Liu et al, 2018), including patients co-infected with HIV (Premkumar et al, 2017). The largest real-life report for treatment of HCV with generic drugs came from the Egyptian national HCV treatment program, where 98.4% of 107,213 patients treated with generic SOF-DCV achieved an SVR (Elsharkawy et al, 2018a).…”

Section: Discussionsupporting

confidence: 78%

High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C

Abozeid

Alsebaey

Abdelsameea

et al. 2018

International Journal of Infectious Diseases

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Section: Discussionsupporting

confidence: 78%

High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C

Abozeid

Alsebaey

Abdelsameea

et al. 2018

International Journal of Infectious Diseases

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“…Recently, two real-world studies evaluating the effectiveness of brand-name or generic SOF/VEL for HCV-2 patients, showing that the SVR 12 rates to be 94% and 98%, respectively. 24,39 Furthermore, SOF/VEL did not provide a better SVR 12 rate than SOF/DCV for these patients. 24 Taken together, SOF in combination with DCV or LDV would also be appealing for DAA-naïve HCV-2 patients, particularly in countries where SOF/VEL has been approved for daily practice.…”

Section: Discussionmentioning

confidence: 83%

“…First, we did not evaluate SOF in combination with velpatasvir (VEL) for HCV‐2 patients because at the time of presentation, SOF/VEL has not been approved by regulatory authorities in Taiwan. Recently, two real‐world studies evaluating the effectiveness of brand‐name or generic SOF/VEL for HCV‐2 patients, showing that the SVR 12 rates to be 94% and 98%, respectively . Furthermore, SOF/VEL did not provide a better SVR 12 rate than SOF/DCV for these patients .…”

Section: Discussionmentioning

confidence: 99%

Sofosbuvir‐based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection

Liu

et al. 2019

J of Gastro and Hepatol

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Background and Aim Data regarding the comparative effectiveness and safety of sofosbuvir (SOF) in combination with ribavirin (RBV), daclatasvir (DCV), or ledipasvir (LDV) for hepatitis C virus genotype 2 (HCV‐2) patients were limited. We aimed to evaluate the performance of these regimens in Taiwan. Methods One hundred eighty‐seven HCV‐2 patients with compensated liver diseases receiving SOF in combination with RBV (n = 82), DCV (n = 66), or LDV (n = 39) for 12 weeks were retrospectively enrolled. The effectiveness was determined by sustained virologic response 12 weeks off therapy (SVR12). The patient characteristics potentially related to SVR12 were compared. The safety profiles and laboratory abnormalities were assessed. Results The SVR12 rates were 93.9% (95% confidence interval [CI]: 86.5–97.4%), 98.5% (95% CI: 91.9–99.7%), and 100% (95% CI: 91.0–100%) in patients receiving SOF combined with RBV, DCV, and LDV, respectively. All patients tolerated treatment well. The stratified SVR12 rates were comparable regardless of baseline characteristics or week 4 viral decline among these regimens. Six (3.2%) patients had serious adverse events which were not related to treatment. The rates of fatigue, pruritus, and anemia tended to be higher in patients receiving RBV (22.0%, 19.5%, and 8.5%) combination than those receiving DCV (10.6%, 6.1%, and 1.5%) or LDV (10.3%, 5.1%, and 0%) combination. Conclusions Sofosbuvir in combination with RBV, DCV, or LDV for 12 weeks is effective and well‐tolerated for HCV‐2 patients. Compared with DCV or LDV combination, the risks of fatigue, pruritus, and anemia are higher in patients receiving RBV combination.

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“…It does not determine the efficacy of SOF/VEL for the treatment of genotype 2 CHC because at the time of this study, SOF/VEL had not been approved in Taiwan. Recently, two real-world studies to determine the effectiveness of brand-name or generic SOF/VEL for patients with genotype 2 CHC showed that the SVR12 rates are 94% and 98%, respectively [37,43] and a combination of SOF/VEL does not result in a higher SVR rate than a SOF/DCV regimen. SOF/RBV or SOF/DCV are important regimens for the treatment of genotype 2 CHC.…”

Section: Discussionmentioning

confidence: 99%

Sofosbuvir-based regimen for genotype 2 HCV infected patients in Taiwan: A real world experience

et al. 2020

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Background Sofosbuvir (SOF)-based regimens achieve excellent efficacy and safety in the treatment of chronic hepatitis C (CHC) with various genotypes. There are few real-world instances of the use of SOF-based regimens to treat genotype 2 CHC. This study determines the effectiveness and safety of SOF/Ribavirn (RBV), SOF/Daclatasvir (DCV) and SOF/DCV/RBV in the treatment of genotype 2 CHC patients in Taiwan. Material and methods Patients with genotype 2 CHC were treated for 12 weeks with SOF/RBV, SOF/DCV or SOF/ DCV/RBV under the National Health Insurance reimbursement program in three hospitals in Taiwan. The sustained virological response at 12 weeks (SVR12) was determined. Adverse events were recorded for a safety analysis. Results A total of 467 genotype 2 CHC patients were enrolled from January to October 2018. One hundred and eleven patients (24%) had cirrhosis, including 10 patients (2.1%) with hepatic decompensation. Fifty-five patients (12%) had already experienced interferon-alpha/RBV treatment. Forty-two patients (9%) had a history of hepatocellular carcinoma (HCC) in the baseline. Three hundred and fifty-five patients received SOF/RBV, forty-seven patients received SOF/DCV and sixty-two patients received SOF/DCV/RBV. The SOF/DCV group featured a greater HCV viral load than the SOF/RBV or SOF/DCV/RBV groups. SVR12 was achieved in 94.6% of the SOF/RBV group, 95.7% of the SOF/DCV group and 96.8% of then SOF/DCV/RBV group (P = NS). Thirteen out of 352 patients (3.7%) in the SOF/RBV group, 1 out of 62 patients (1.6%) in the SOF/DCV/RBV group and 1 out of 47 patients (2.1%) in

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Generic velpatasvir plus sofosbuvir for hepatitis C virus infection in patients with or without human immunodeficiency virus coinfection

Abstract: Generic VEL/SOF-based therapy is well-tolerated and provides comparably high SVR rates for HCV infection in patients with and without HIV coinfection.

Cited by 25 publications

References 42 publications

High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C

High efficacy of generic and brand direct acting antivirals in treatment of chronic hepatitis C

Sofosbuvir‐based direct acting antiviral therapies for patients with hepatitis C virus genotype 2 infection

Sofosbuvir-based regimen for genotype 2 HCV infected patients in Taiwan: A real world experience

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