Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden

Isakov, Vasily; Chulanov, Vladimir; Abdurakhmanov, Dzhamal; Бурневич, Э З; Nurmukhametova, E.; Кожевникова, Г М; Gankina, Natalya; Журавель, С. В.; Romanova, S. Yu.; Hyland, Robert H.; Lu, Sophia; Svarovskaia, Evguenia S.; McNally, John; Brainard, Diana M.; Vt, Ivashkin; Морозов, В. Г.; Бакулин, И. Г.; Lagging, Martin; Жданов, К. В.; Weiland, Ola

doi:10.1080/23744235.2018.1535186

Cited by 13 publications

(14 citation statements)

References 19 publications

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“…Several well-designed, robust clinical trials have demonstrated the safety (147) and high curative efficacy of glecaprevir/pibrentasvir (148)(149)(150)(151)(152)(153)(154)(155)(156)(157)(158) and sofosbuvir/ velpatasvir (159)(160)(161)(162)(163)(164) among treatment-naive persons without cirrhosis regardless of HCV genotype. These findings have been confirmed in real-world cohort studies for both glecaprevir/pibrentasvir (165)(166)(167) and sofosbuvir/velpatasvir.…”

Section: Simplified Hcv Treatment Algorithm For Treatment-naive Adultmentioning

confidence: 99%

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

2020

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Section: Simplified Hcv Treatment Algorithm For Treatment-naive Adultmentioning

confidence: 99%

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

2020

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“…SVR12 was achieved by 99% (118/119) of participants from Russia (n=103) and Sweden (n=16) receiving sofosbuvir/velpatasvir for 12 weeks. 19 In this study, 59% of patients had HCV GT1b infection, 76% were treatment naive, and 18% had cirrhosis. One case of virologic failure occurred in a participant with GT3 infection who had a treatmentemergent Y93H RAS at the time of failure.…”

Section: Dovepressmentioning

confidence: 60%

<p>Elbasvir/Grazoprevir for HCV Infection in Russia: A Randomized Trial</p>

Жданов

Isakov

Бурневич

et al. 2020

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Purpose: Hepatitis C virus (HCV) infection is a major healthcare concern in Russia, where almost 5 million individuals are viremic. Elbasvir/grazoprevir is a fixed-dose combination therapy for the treatment of HCV genotype 1 and genotype 4 infection. The present analysis aimed to assess the safety and efficacy of elbasvir/grazoprevir in individuals with HCV infection enrolled at Russian study sites in the C-CORAL study. Patients and Methods: C-CORAL (Protocol PN-5172-067; NCT02251990) was a Phase 3, placebo-controlled, double-blind study conducted throughout Asia and Russia. Treatment-naive participants with chronic HCV infection were randomly assigned to receive immediate or deferred treatment with elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks. Participants in the immediate-treatment group received elbasvir/grazoprevir for 12 weeks, and those in the deferred-treatment group received placebo for 12 weeks, followed by open-label elbasvir/grazoprevir for 12 weeks. The primary endpoint was sustained virologic response at 12 weeks after completion of therapy (SVR12). Results: One hundred and nineteen Russian participants were randomized (immediatetreatment group, n=88; deferred-treatment group, n=31). Most participants were white (99%) with HCV genotype 1b infection (97%) and mild-to-moderate (F0-F2) fibrosis (70%). SVR12 was achieved by 98.9% participants in the immediate-treatment group and by 100% of those receiving deferred elbasvir/grazoprevir in the deferred-treatment group. One participant relapsed with nonstructural protein 5A (NS5A) L28M and Y93H resistanceassociated substitutions at baseline and at time of failure. Drug-related adverse events were reported by 19% of participants receiving elbasvir/grazoprevir in the immediate-treatment group and by 16% of those receiving placebo in the deferred-treatment group. No serious adverse event or deaths occurred, and no participant discontinued treatment owing to an adverse event. Conclusion: Elbasvir/grazoprevir for 12 weeks was highly effective in treatment-naive Russian individuals with HCV genotype 1b infection.

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“…The range of clinical sites included Europe, North America, Asia, and Australia. Nine out of eleven ; 10 studies recruited patients with GT3, who had previous anti-HCV treatment, with most of the patients having a history of previous treatments with interferon-based regimens (10,(18)(19)(20)(21)(22)(24)(25)(26). Notably, seven trials included patients with GT3 and baseline NS5A RAVs (10, 18-20, 24, 26), although the proportions of these subgroups varied and are listed in detail in Table 3.…”

Section: Characteristics Of Studies and Patientsmentioning

confidence: 99%

“…PRISMA flow diagram (9/11) trials recruited patients presenting compensated cirrhosis and the GT3(10,(18)(19)(20)(21)(22)(24)(25)(26). In addition, two studies included a small number of patients with Child-Pugh B cirrhosis(21,22)…”

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confidence: 99%

Sustained Virologic Response Rates of Sofosbuvir and Velpatasvir in Patients with Hepatitis C Genotype 3: A Meta-Analysis

2020

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Context: Patients with hepatitis C virus (HCV) genotype 3 are regarded as a difficult-to-cure population in an era of direct-acting antiviral treatment. Objectives: This meta-analysis aimed to evaluate sustained virologic response rates resulting from a fixed-dose combination of sofosbuvir (SOF) and velpatasvir (VEL), also known as Epclusa ® (Gilead, Forster City, CA) in patients with HCV genotype 3. Methods: In this study, we searched PubMed/MEDLINE, Embase, and the Cochrane Library for relevant studies from inception until May 3rd, 2019. The primary outcome measure used was the rate of the sustained virological response at week-12 (SVR12) posttreatment. The heterogeneity of results was evaluated, and influence analyses were performed using the R software. In addition, publication bias was assessed using the funnel and Egger tests. Results: Eleven trials (n = 2246 patients) were included in this meta-analysis. The pooled SVR12 rate in patients with HCV-genotype 3 (GT3) was 94.6% with a random effect model by inverse method (95% Cl 92.5%-96.1%, I2 = 53%, P = 0.02). A subpopulation analysis indicated that the pooled SVR12 rates were 96.3% in GT3 patients with compensated cirrhosis and 94.0% in GT3 patients with prior anti-HCV treatment. Moreover, influence analysis suggested that the most significant source of heterogeneities resulted from one trial, which enrolled most patients with HCV subtype 3b. Conclusions: Our meta-analysis showed a high SVR12 rate of SOF/VEL in GT3 patients regardless of compensated cirrhosis the status and/or a history of previous interferon-based treatments. These results highlight the need for more trials investigating the effectiveness of the SOF/VEL regimen in patients with HCV subtype 3b.

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Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden

Cited by 13 publications

References 19 publications

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases–Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection

<p>Elbasvir/Grazoprevir for HCV Infection in Russia: A Randomized Trial</p>

Sustained Virologic Response Rates of Sofosbuvir and Velpatasvir in Patients with Hepatitis C Genotype 3: A Meta-Analysis

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