Safety and efficacy of elbasvir/grazoprevir in Asian participants with hepatitis C virus genotypes 1 and 4 infection

Abstract

Background and Aim Estimates suggest that in Asia, more than 31 million individuals have hepatitis C virus infection. The present analysis was conducted to assess the efficacy and safety of elbasvir/grazoprevir in Asian participants enrolled in the elbasvir/grazoprevir phase 2/3 clinical trials. Methods This is an integrated analysis of data from 12 international phase 2/3 clinical trials. Asian participants with chronic hepatitis C virus genotype 1 or 4 infection who received elbasvir 50 mg/grazoprevir 100 mg once daily for 12 weeks or elbasvir/grazoprevir plus ribavirin for 16 weeks were included in this analysis. The primary end point was sustained virologic response at 12 weeks after completion of therapy (SVR12). Results Seven hundred eighty Asian participants from 15 countries were included in this analysis. SVR12 was achieved by 756/780 (96.9%) of all participants, including 748/772 (96.9%) of those who received elbasvir/grazoprevir for 12 weeks and 8/8 (100%) of those who received elbasvir/grazoprevir plus ribavirin for 16 weeks. In the genotype 1b‐infected population, the SVR12 rate was 691/709 (97.5%), and there was no impact of age, high baseline viral load, or presence of cirrhosis. The most frequently reported adverse events were nasopharyngitis (8.0%), upper respiratory tract infection (5.4%), and diarrhea (5.2%). Twenty participants receiving elbasvir/grazoprevir for 12 weeks reported a total of 25 serious adverse events, and 7 (0.9%) discontinued treatment because of an adverse event. Conclusion Elbasvir/grazoprevir administered for 12 weeks is an effective and generally well‐tolerated treatment option for Asian individuals with hepatitis C virus genotype 1b infection.

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

“…Previously reported data from the C-CORAL study indicate that EBR/GZR for 12 weeks is a safe and highly effective treatment option for people with HCV GT1 infection from the Asia-Pacific region and Russia. 16,17 In the present analysis, these observations were extended to confirm high rates of SVR12 among participants enrolled in Russia. This was a treatment-naive population with primarily HCV GT1b infection: 70% had mild to moderate (F0-F2) liver fibrosis, and 39% had baseline HCV RNA <800,000 IU/mL.…”

“…The primary outcomes from this study and data from a prespecified interim analysis of participants enrolled at study centers outside China have been published previously. 16,17 Participants Adult treatment-naive participants with chronic HCV GT1, GT4, or GT6 infection and HCV RNA ≥10,000 IU/mL at baseline were enrolled at 15 study sites in Russia. Individuals with and without cirrhosis were eligible, with cirrhosis defined as METAVIR F4 on liver biopsy within 24 months of enrollment, FibroScan ® >12.5 kPa within 12 months of enrollment, or a combination of FibroTest ® score >0.75 and aspartate aminotransferase (AST):platelet ratio index >2.…”

“…The present analysis population, which includes only the Russian subgroup of participants from this previously reported dataset, accounts for 24.3% of the total C-CORAL population and is largely representative of the overall study results. 17 Several other studies have also examined the safety and efficacy of direct-acting antiviral therapies for the treatment of HCV infection in Russian patients. SVR12 was achieved by 99% (118/119) of participants from Russia (n=103) and Sweden (n=16) receiving sofosbuvir/velpatasvir for 12 weeks.…”

“…The clinical profile of EBR/GZR in people with HCV infection from Asia and Russia was established in the phase 3 C-CORAL study. 16,17 In a study population of 489 participants with HCV GT1, GT4, or GT6 infection receiving EBR/GZR for 12 weeks, 459 (94.4%) achieved a sustained virologic response at 12 weeks after completion of treatment (SVR12). Of the 25 participants with virologic failure in this study, 17 had HCV GT6 infection and were primarily enrolled in Thailand and Vietnam.…”

Cost-Effectiveness of Testing for NS5A Resistance to Optimize Treatment of Elbasvir/Grazoprevir for Chronic Hepatitis C in China

“…For example, patients with chronic HCV genotype 1b (GT 1b) infection received elbasvir/grazoprevir (ELB/GZR), one commonly used combination therapy, achieves SVR rate of 90.0% over the shortened 8-weeks treatment (Huang et al, 2019), and a higher rate (97.5%) after the standard 12-weeks treatment (Huang et al, 2019;Wei et al, 2019a). Nevertheless, patients resistant to NS5A have a significantly lower cure rate over the 8-weeks treatment (75%) than over the 12-weeks treatment (94.3%) (Huang et al, 2019;Wei et al, 2019b).…”