Meta-Analysis of Grazoprevir plus Elbasvir for Treatment of Hepatitis C Virus Genotype 1 Infection

Ahmed, Hussien; Abushouk, Abdelrahman Ibrahim; Menshawy, Amr; Attia, Attia; Mohamed, Arwa; Negida, Ahmed; Abdel-Daim, Mohamed M.

doi:10.5604/01.3001.0010.7532

Cited by 29 publications

(18 citation statements)

References 40 publications

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“…However, the increased response with ELB/GRZ was not seen in patients receiving 16‐week treatment with RBV (those with the Y93 NS5A polymorphism) where response rates were comparable to other regimens. The reasons underlying the differences in efficacy of the different regimens is not clear; however, given that the variation between the regimens was only seen in patients with G1a who received 12 weeks of ELB/GRZ and therefore did not have the Y93 resistance polymorphism, it is probable that the differences reflect the exclusion of the most difficult viral strains 17 from this cohort. In this nonrandomised allocation of patients, it is possible that clinicians chose to avoid ELB/GRZ in patients who might have been at risk of decompensated cirrhosis (where the drug is contraindicated) and therefore the cohort of patients receiving ELB/GRZ may have been slightly easier to cure and thereby more likely to achieve SVR.…”

Section: Discussionmentioning

confidence: 98%

English hepatitis C registry data show high response rates to directly acting anti‐virals, even if treatment is not completed

Drysdale

Ntuli

Bestwick

et al. 2020

Aliment Pharmacol Ther

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Summary Background In England, choice of hepatitis C therapy is determined by national contracts that change with time, facilitating comparisons between different regimens. England has a diverse population with hepatitis C including large proportions of uncommon viral genotypes. Aim To evaluate efficacy of directly acting anti‐viral treatments for hepatitis C in England using real‐world data from the national treatment registry. Methods Sustained virological response (SVR) rates 12 weeks after treatment completion for patients treated between 2014 and August 2018 who attended for SVR tests were analysed in univariate subgroups using Chi‐squared tests. Multivariate models were constructed with clinically relevant variables to determine predictors of SVR and evaluate the impact of treatment regimens. Results SVR data were available on 14,603 treated patients. The overall SVR rate was 95.59% [95% CI 95.25%‐95.91%]. Multivariable regression modelling in patients with genotype 1 infection showed that the odds of SVR with elbasvir/grazoprevir were higher than for those treated with sofosbuvir/ledipasvir (OR 1.891, 95% CI 1.072‐3.336, P = 0.028). For genotype 3, we found no significant difference between any of the treatment regimens. Patients who completed at least one third of the planned treatment duration achieved SVR rates in excess of 80%. Conclusions All of the currently licensed hepatitis C direct‐acting anti‐viral regimens had similar efficacy (>95%) in an unselected population. Noncompletion of planned treatment duration still resulted in over 80% SVR rates provided that more than one third of treatment was completed.

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Section: Discussionmentioning

confidence: 98%

English hepatitis C registry data show high response rates to directly acting anti‐virals, even if treatment is not completed

Drysdale

Ntuli

Bestwick

et al. 2020

Aliment Pharmacol Ther

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“…Several studies described that there were 3 relapses occurring by post-therapy week 8 whom baseline RAVs stably reappeared at relapse and persisted throughout for the full 24-week follow-up period ( Buti et al, 2016 ). Also, the relapse rate for EBR/GZR was 1.4% in meta-analysis ( Ahmed et al, 2018 ). The OBV/PTV/r virologic relapse rate of GT1 patients was 1.3% ( Wedemeyer et al, 2017 ).…”

Section: Discussionmentioning

confidence: 99%

A Retrospective Cohort Study: Safety and Effectiveness of Elbasvir/Grazoprevir ± Ribavirin Compared With Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir ± Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Infection

Hung

Liao²

2021

Front. Pharmacol.

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Background: The direct-acting antiviral (DAA) agents are widely used to treat hepatitis C virus (HCV) genotype (GT) 1 infection, while it may cause severe liver damage. The objectives of the study were to evaluate the incidence of drug-induced liver injury (DILI), sustained virologic response at post-treatment week 12 (SVR12), and recurrence rates in HCV GT 1 infection.Methods: This was a retrospective cohort study that included patients diagnosed with HCV GT 1 infection, who had received intervention and treatment with elbasvir/grazoprevir (EBR/GZR) ± ribavirin (RBV) versus ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + dasabuvir ± RBV (as control group) for 12 or 24 weeks at a regional hospital in southern Taiwan between April 2016 and August 2018. The primary outcome of the study was to compare the incidence rate ratio (IRR) of DILI via Poisson regression, and the secondary outcome was to evaluate the effectiveness of two treatment regimens expressed as a percentage.Results: The study included 149 patients in the control group and 105 patients in the intervention group of which 99.33 and 98.1% patients, respectively, achieved SVR12. In the control group, one patient experienced relapse, whereas in the intervention group, two patients relapsed. Furthermore, in the control group, a total of nine patients developed DILI as determined during follow-up care. Of these patients, three were 55–84 years old. In the intervention group, six patients developed DILI. The IRR of DILI caused by EBR/GZR treatment was 2.84 times higher than that caused by the OBV/PTV/r treatment regimen.Conclusion: There was no significant difference between the studied DAA regimens regarding the incidence of DILI and effectiveness during the treatment. DILI occurrence during therapy did not affect the cure rate of medication. The present study results can provide reference data for drug selection among patients with HCV.Trial registration: The study was approved by DMF-CYCH (CYCH IRB No: 2018067).

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“…For HCV genotype 1, a systematic search of existing meta-analyses on the efficacy of DAA regimens in genotype 1 was performed, which identified 7 relevant meta-analyses. 39 , 40 , 41 , 42 , 43 , 44 , 45 Individual trials were extracted from these meta-analyses by DAA regimens. For regimens that had only 1 meta-analysis (such as SOF/VEL), we used the result of that meta-analysis; meanwhile, for regimens that had more than 1 meta-analysis (such as SOF/LDV and SOF+DCV), we performed a new pooling and used our pooled result.…”

Section: Methodsmentioning

confidence: 99%

Cost-Utility Analysis of Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Genotype 1 and 6 in Vietnam

Thakkinstian¹,

Thavorncharoensap

Sobhonslidsuk

et al. 2020

Value in Health

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Objective Very few cost-utility analyses have either evaluated direct-acting antivirals (DAAs) on hepatitis C virus (HCV) genotype 6 patients or undertaken societal perspective. Recently, DAAs have been introduced into the Vietnamese health insurance drug list for chronic hepatitis C (CHC) treatment without empirical cost-effectiveness evidence. This study was conducted to generate these data on DAAs among CHC patients with genotypes 1 and 6 in Vietnam. Methods A hybrid decision-tree and Markov model was employed to compare costs and quality-adjusted life-years (QALYs) of available DAAs, including (1) sofosbuvir/ledipasvir, (2) sofosbuvir/velpatasvir, and (3) sofosbuvir plus daclatasvir, with pegylated-interferon plus ribavirin (PR). Primary data collection was conducted in Vietnam to identify costs and utility values. Incremental cost-effectiveness ratios were estimated from societal and payer perspectives. Uncertainty and scenario analyses and value of information analyses were performed. Results All DAAs were cost-saving as compared with PR in CHC patients with genotypes 1 and 6 in Vietnam, and sofosbuvir/velpatasvir was the most cost-saving regimen, from both societal and payer perspectives. From the societal perspective, DAAs were associated with the increment of quality-adjusted life-years by 1.33 to 1.35 and decrement of costs by $6519 to $7246. Uncertainty and scenario analyses confirmed the robustness of base-case results, whereas the value of information analyses suggested the need for further research on relative treatment efficacies among DAA regimens. Conclusions Allocating resources for DAA treatment for HCV genotype 1 and 6 is surely a rewarding public health investment in Vietnam. It is recommended that the government rapidly scale up treatment and enable financial accessibility for HCV patients.

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Meta-Analysis of Grazoprevir plus Elbasvir for Treatment of Hepatitis C Virus Genotype 1 Infection

Abstract: We conclude that the 12-week treatment regimen of the fixed dose combination of grazoprevir plus elbasvir achieved high SVR rates in patients with HCV genotype 1 infection. The addition of ribavirin to this regimen did not add a significant benefit.

Cited by 29 publications

References 40 publications

English hepatitis C registry data show high response rates to directly acting anti‐virals, even if treatment is not completed

English hepatitis C registry data show high response rates to directly acting anti‐virals, even if treatment is not completed

A Retrospective Cohort Study: Safety and Effectiveness of Elbasvir/Grazoprevir ± Ribavirin Compared With Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir ± Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Infection

Cost-Utility Analysis of Direct-Acting Antivirals for Treatment of Chronic Hepatitis C Genotype 1 and 6 in Vietnam

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