Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir

Aghemo, Alessio; Horsmans, Yves; Bourgeois, Stefan; Bondin, Mark; Gschwantler, Michael; Hofer, Harald; Semmo, Nasser; Negro, Francesco; Zhang, Zhenzhen; Marcinak, John; Veitsman, Ella; Hazzan, Rawi; Mimidis, Konstantinos; Goulis, Ioannis; Marques, Nuno; Flisiak, Robert; Mazur, Włodzimierz; Roncero, Carlos; Marra, Fiona; Pageaux, Georges Philippe; Asselah, Tarik; Lampertico, Pietro

doi:10.1007/s40121-021-00455-1

Cited by 17 publications

(16 citation statements)

References 46 publications

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“…The favorable safety profile of G/P in this real-world cohort was consistent with that reported in previous clinical trials and real-world studies of G/P for patients with CC [ 8 , 12 ], including EXPEDITION-8, where no serious drug-related AEs or discontinuations due to AEs were reported [ 9 ]. Furthermore, the high SVR12 rates observed in patients traditionally considered as being underserved are in line with the findings from studies which have demonstrated that G/P treatment was highly effective in patients with substance abuse and psychiatric comorbidities [ 13 , 14 , 17 ].…”

Section: Discussionsupporting

confidence: 83%

“…A few real-world studies have evaluated G/P in patients with CC, with a special interest in harder-to-treat groups such as those with comorbidities, those with HCV GT3 infection, people who use drugs (PWUD), those with a psychiatric disorder, and those with other barriers to treatment [ 11 – 14 ]. These studies have shown that SVR12 rates with G/P remain high and ≥ 98% in the PP population of GT1–6 patients [ 11 , 12 , 15 ].…”

Section: Introductionmentioning

confidence: 99%

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Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

et al. 2022

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Introduction In clinical trials with hepatitis C virus-infected treatment-naïve (TN) patients with compensated cirrhosis (CC), glecaprevir/pibrentasvir (G/P), a fixed-dose, once-daily, pangenotypic regimen, has demonstrated sustained virologic response at posttreatment Week 12 (SVR12) > 95%. We evaluated the real-world safety and effectiveness of 8-week G/P therapy in TN patients with CC, including certain subgroups of interest. Methods The CREST study is a real-world, noninterventional, multicenter study retrospectively assessing data from Canada, Germany, Israel, Italy, and Spain. The full analysis set (FAS) designated all patients in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 data. The primary endpoint was SVR12; safety endpoints were also assessed. Results A total of 386 patients were included in the FAS, 375 patients completed the study, and 325 patients were included in the MAS; 51 patients had missing SVR12 data. Overall, in the MAS and FAS, SVR12 was achieved in 99.1% and 84.2% of patients, respectively. In subgroups of interest, the percentage of patients achieving SVR12 in the MAS (and FAS) was: genotype (GT)3: 97.5% (80.6%); FibroScan ® ≥ 12.5 kPa: 98.9% (89.3%); platelet count < 100 × 10 9 /l: 100% (88.2%); both platelets < 150 × 10 9 /l and FibroScan ® > 20 kPa: 100% (88.9%); aspartate aminotransferase-to-platelet ratio index > 1.09: 98.7% (83.1%); fibrosis-4 index > 3.25: 98.6% (84.0%); albumin < 3 g/dl: 100% (91.7%); people who use drugs: 97.7% (84.3%); psychiatric disorders: 96.6% (84.8%); and human immunodeficiency virus coinfection: 100% (95.0%). Overall, 26.9% (104/386) of patients experienced an adverse event, none of which were classed as serious. Conclusion In this real-world cohort, 8 weeks of G/P therapy was well tolerated in TN patients with CC. SVR12 rates were similar to clinical trials, supporting 8-week treatment in TN patients with CC, including those with signs of advanced liver disease and GT3 infection.

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Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

et al. 2022

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“…The proportion of patients with current or former drug abuse was lower than expected (12%) compared with epidemiological data from Italy which estimated that 49% of patients with HCV are people who inject/injected drugs [ 4 ]. The proportion of patients with alcohol dependence was also lower (4.8%) than previously reported [ 23 , 34 ].…”

Section: Discussioncontrasting

confidence: 68%

Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study

et al. 2023

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Introduction Glecaprevir/pibrentasvir (G/P) has demonstrated high rates (>95%) of sustained virologic response at posttreatment Week 12 (SVR12) in treatment-naïve (TN) patients with hepatitis C virus (HCV) infection and compensated cirrhosis (CC). Here, in a key real-world subset of TN Italian patients with CC, we evaluated the effectiveness and safety of 8-week G/P treatment, including subgroups of interest such as those with genotype 3 (GT3) infection, elderly patients, and those with more advanced liver disease. Methods Subanalysis of Italian patients enrolled in the CREST study. The full analysis set (FAS) included all patients enrolled in the study; the modified analysis set (MAS) excluded patients who discontinued G/P for nonvirologic failure or who had missing SVR12 results. Primary and secondary endpoints included SVR12 and safety, respectively. Results Of 42 patients included in the FAS, 1 discontinued for unknown reasons, and 2 had missing SVR12 data, leaving 39 patients included in the MAS. At treatment initiation, 74% of patients had ≥1 comorbidity, and 62% were receiving concomitant medications, including some that may potentially interact with G/P. SVR12 was achieved in 100% of patients in the MAS, and in 95% in the FAS. In subgroups of interest, the proportion of patients achieving SVR12 in the MAS (and FAS) was: 100% (94%) for patients ≥65 years, 100% (86%) for GT3, and 100% (100%) for patients with platelet count <150 × 109/L and FibroScan® >20 kPa. Overall, 2 (5%) patients had an adverse event and neither were serious. Conclusion Results from this real-world Italian cohort demonstrated the safety and effectiveness of 8-week G/P, with SVR12 rate >95%, even in elderly patients. These findings further support real-world evidence of the use of short-course G/P treatment in all patients with CC, including those with GT3, and those with advanced liver disease.

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“…6 The overall SVR12 rate of non-GT3-infection versus GT3-infection in ITT population Fig. 7 The overall SVR12 rate of non-cirrhosis versus cirrhosis in ITT population patients participating in clinical trials, these patients are more heterogeneous and more inclusive of marginalized populations [38]. They provide valuable information for patients, doctors, decision-makers, and payers and are an important supplement to the results of clinical trials [19].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir as a Hepatitis C Virus Infection Salvage Therapy in the Real World: A Systematic Review and Meta-analysis

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Wei

et al. 2022

Infect Dis Ther

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Introduction: Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) is the first direct-acting antiviral (DAA) therapy approved for patients who have previously failed a DAA-containing regimen including NS5A inhibitors. In clinical trials, SOF/VEL/VOX was associated with high rates of sustained virologic response at posttreatment week 12 (SVR12) and was well tolerated. However, the effectiveness and safety of SOF/VEL/VOX in the real world remained uncertain. We aimed to perform a systematic review and meta-analysis to assess the real world effectiveness and safety of SOF/VEL/VOX. Methods: We systematically searched the PubMed, Embase, Cochrane Library, Web of Science, and ClinicalTrials.gov databases for relevant real world studies published before January 28, 2022. Patients with previous treatment failure who received SOF/VEL/VOX were included. The primary outcome was the

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Real-World Outcomes in Historically Underserved Patients with Chronic Hepatitis C Infection Treated with Glecaprevir/Pibrentasvir

Cited by 17 publications

References 46 publications

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

Safety and Effectiveness Using 8 Weeks of Glecaprevir/Pibrentasvir in HCV-Infected Treatment-Naïve Patients with Compensated Cirrhosis: The CREST Study

Safety and effectiveness of 8 weeks of Glecaprevir/Pibrentasvir in challenging HCV patients: Italian data from the CREST study

Effectiveness and Safety of Sofosbuvir/Velpatasvir/Voxilaprevir as a Hepatitis C Virus Infection Salvage Therapy in the Real World: A Systematic Review and Meta-analysis

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