Safety of Patients with Hepatitis C Virus Treated with Glecaprevir/Pibrentasvir from Clinical Trials and Real-World Cohorts

Forns, Xavier; Feld, Jordan J.; Dylla, Douglas E.; Pol, Stanislas; Chayama, Kazuaki; Hou, Jinlin; Heo, Jeong; Lampertico, Pietro; Brown, Ashley; Bondin, Mark; Tatsch, Fernando; Burroughs, Margaret; Marcinak, John; Zhang, Zhenzhen; Emmett, Amanda; Gordon, Stuart C.; Jacobson, Ira M.

doi:10.1007/s12325-021-01753-3

Cited by 9 publications

(4 citation statements)

References 28 publications

(33 reference statements)

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“…The data in this paper build on those in large real-world cohorts across wide ranging populations covering those with cirrhosis, pediatric patients, and those with GT3 infection, further demonstrating the breadth of applicability for the regimen without compromising safety/efficacy [ 11 , 20 – 25 ]. In this analysis, the proportion of patients with clinical evidence suggestive of PHT at baseline was similar between groups treated with 8 and 12 weeks of G/P, suggesting that the patient population in EXPEDITION-8 was similar to those in previous clinical trials of 12-week G/P.…”

Section: Discussionmentioning

confidence: 97%

Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension

et al. 2022

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Introduction: High efficacy and safety of 8-week glecaprevir/pibrentasvir (G/P) therapy was seen in hepatitis C (HCV)-infected, treatment-naı ¨ve (TN), compensated cirrhosis (CC) patients in EXPEDITION-8. To provide further understanding of the efficacy of G/P treatment in HCV-infected TN patients with CC and clinical evidence of portal hypertension (PHT), this analysis focused on differences in sustained virologic response at post-treatment week 12 (SVR12) between 8-week and 12-week G/P treatment groups in patients with PHT, and on differences in safety outcomes between PHT and non-PHT groups.Methods: Data were derived from an ad hoc subgroup analysis of the EXPEDITION-8 study for patients receiving 8 weeks of G/P therapy, and pooled patient-level data from nine clinical studies for patients receiving 12 weeks of therapy. Evidence of PHT included at least one of the following at baseline: FibroScan C 20 kPa, platelets\100 9 10 9 /L, or medical history consistent with PHT. The primary efficacy endpoint was SVR12; adverse events (AEs) consistent with hepatic decompensation were assessed. Results: PHT was identified in 60.6% (208/343) and 57.1% (224/392) of the 8-and 12-week groups, respectively. For those with PHT, SVR12 was 97.6% (203/208) and 98.7% (221/224) with 8-and 12-week treatment, respectively (intention-to-treat population). For those without PHT, 97.8% (132/ 135) in the 8-week group and 97.6% (164/168) in the 12-week group achieved SVR12. Eight patients with PHT, and seven without, did not achieve SVR12. Similar rates of AEs were observed in the PHT and non-PHT groups. Three cases of hepatic decompensation in the PHT group, unrelated to G/P according to the investigators, were reported. Conclusion: G/P treatment for 8 or 12 weeks was equally efficacious in HCV patients with features of PHT. Safety outcomes were similar between PHT and non-PHT groups, with G/P treatment well tolerated across groups. NCTs: NCT03089944,

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Section: Discussionmentioning

confidence: 97%

Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension

et al. 2022

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“…These results were in accordance with previous study which also found that SVR obtained by DAAs therapy was correlated to improved OS and PFS in HCV-related HCC patients. 36,37 The safety and efficiency of DAAs therapy has been confirmed by various studies, 38 as it has the advantage of shorter treatment duration, better response rates, and milder side effects. 33,39 Recently, the arrival of IFN-free DAAs has not only revolutionized the treatment of HCV infection, but also impacted the epidemiological landscape for HCV-related HCC.…”

Section: Discussionmentioning

confidence: 91%

“…The safety and efficiency of DAAs therapy has been confirmed by various studies, 38 as it has the advantage of shorter treatment duration, better response rates, and milder side effects 33,39 . Recently, the arrival of IFN‐free DAAs has not only revolutionized the treatment of HCV infection, but also impacted the epidemiological landscape for HCV‐related HCC.…”

Section: Discussionmentioning

confidence: 98%

Clinical benefits of direct‐acting antivirals therapy in hepatitis C virus patients with hepatocellular carcinoma: A systematic review and meta‐analysis

Liu

Yang

Dong

et al. 2022

J of Gastro and Hepatol

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Background and Aim:The purpose of the present study was to evaluate the effect of direct-acting antivirals (DAAs) therapy on the clinical outcomes of hepatitis C virus (HCV) patients with hepatocellular carcinoma (HCC). Methods: We searched multiple electronic databases from database inception to June 14, 2021. Meta-analyses were performed separately for HCC recurrence and overall survival (OS). Results: A total of 23 studies were identified for the primary analysis. Compared with no intervention, pooled data showed significant benefit from DAAs therapy in reducing recurrence (adjusted HR = 0.55, 95% CI 0.41-0.74, P < 0.001; I 2 = 66.6%, P < 0.001) and improving OS (adjusted HR = 0.36, 95% CI 0.16-0.83, P = 0.017; I 2 = 90.7%, P < 0.001) of HCV-related HCC patients. Compared with non-responders, patients with sustained virologic response (SVR) had greater benefit from DAAs therapy in reducing recurrence (HR = 0.37, 95% CI 0.16-0.84, P = 0.017; I 2 = 58.8%, P = 0.088) and improving OS (HR = 0.17; 95% CI 0.06-0.50; P = 0.001; I 2 = 56.4%, P = 0.130). Though DAAs did not show significant advantages over IFN in reducing recurrence (adjusted HR = 0.96, 95% CI 0.72-1.28, P = 0.784; I 2 = 0.0%, P = 0.805), there seems to be a trend toward OS benefit from DAAs therapy (adjusted HR = 0.11, 95% CI 0.01-1.19, P = 0.059). Conclusion: DAAs therapy can prevent recurrence and improve OS of HCV-related HCC patients, especially for patients with SVR. Further prospective randomized controlled trial is warranted to validate these results.

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“…A post hoc analysis of G/P in patients in clinical trials and real-world studies found that it was well tolerated in different populations of patients. 8 However other DAAs, such as sofosbuvir/ledipasvir, have shown higher relapse rates for 8 week treatment compared with 12 week treatment among PLWH. 9 Also, the higher proportion of active drug users among coinfected HIV/HCV patients compared with HCV-monoinfected patients could result in reduced sustained viral response (SVR) rates.…”

Section: Introductionmentioning

confidence: 99%

Response to glecaprevir/pibrentasvir in HIV/HCV-coinfected patients in clinical practice

Gonzalez-Serna,

Corma-Gomez,

Tellez

et al. 2023

Journal of Antimicrobial Chemotherapy

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Objectives HIV infection has been associated with lower rates of sustained viral response (SVR) with direct-acting antivirals (DAAs). There are few data on glecaprevir/pibrentasvir (G/P) in HIV/HCV coinfection outside clinical trials. Methods The HEPAVIR-DAA cohort, which recruits HIV/HCV-coinfected patients (NCT02057003) and the GEHEP-MONO cohort (NCT02333292), including HCV-monoinfected individuals, are two concurrent ongoing multicentre cohorts of patients receiving anti-HCV treatment. Patients starting G/P included in those cohorts were analysed. Overall SVR (ITT), discontinuations due to adverse effects, and dropouts were evaluated and compared between both cohorts. Results Of the 644 patients who started G/P with evaluable SVR, 132 were HIV/HCV coinfected. Overall SVR rates were 487/512 (95.1%) in HCV-monoinfected patients versus 126/132 (95.5%) in HIV/HCV-coinfected patients (P = 1.000). One patient (0.8%) relapsed, and another (0.8%) discontinued treatment due to side effects. SVR to 8 or 12 weeks of treatment with G/P was similar in HIV/HCV-coinfected versus HCV-monoinfected patients. The main reason for not reaching SVR among HIV/HCV-coinfected patients was premature dropout linked to active drug use. Conclusions G/P in HIV/HCV coinfection was highly effective and tolerable in clinical practice. SVR to 8 or 12 weeks of treatment with G/P was similar in HIV/HCV-coinfected compared with HCV-monoinfected patients but active drug use is still a barrier to reach HCV microelimination.

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Safety of Patients with Hepatitis C Virus Treated with Glecaprevir/Pibrentasvir from Clinical Trials and Real-World Cohorts

Cited by 9 publications

References 28 publications

Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension

Efficacy and Safety of 8- or 12 Weeks of Glecaprevir/Pibrentasvir in Patients with Evidence of Portal Hypertension

Clinical benefits of direct‐acting antivirals therapy in hepatitis C virus patients with hepatocellular carcinoma: A systematic review and meta‐analysis

Response to glecaprevir/pibrentasvir in HIV/HCV-coinfected patients in clinical practice

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