Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study

Fontana, Robert J.; Lens, Sabela; McPherson, Stuart; Elkhashab, Magdy; Ankoma‐Sey, Victor; Bondin, Mark; Santos, Ana Gabriela Pires dos; Xue, Zhenyi; Trinh, Roger; Porcalla, Ariel; Zeuzem, Stefan

doi:10.1007/s12325-019-01123-0

Cited by 9 publications

(19 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Overall, 25 studies (21 publications and 4 unpublished clinical trials; ClinicalTrials.gov Nos. NCT02707952 substudy1, 3 NCT02723084, 4 NCT02604017, 5 NCT02640482, 6 NCT02640157, 5 NCT02636595, 6 , 7 NCT02966795, 8 NCT02642432, 9 NCT02738138, 10 NCT02651194, 11 NCT03069365, 12 NCT03089944, 13 NCT02446717, 14 , 15 NCT02692703, 16 NCT03117569, 17 NCT02243293, 6 , 18 , 19 NCT03222583, 20 NCT03235349, 21 NCT03092375, 22 NCT03212521, 23 NCT03219216 24 ) were included in this review. A flow chart of the study selection is presented in Fig.…”

Section: Resultsmentioning

confidence: 99%

“…SVR12 rates by GT were described in 13 phase III clinical trials (ClinicalTrials.gov Nos. NCT02707952, 3 NCT02723084, 4 NCT02604017, 5 NCT02640482, 6 NCT02640157, 5 NCT02636595, 6 , 7 NCT02966795, 8 NCT02642432, 9 NCT03089944, 13 NCT02446717, 14 , 15 NCT02243293, 6 , 18 , 19 NCT03222583, 20 NCT03092375, 22 NCT03212521 23 ), including 3585 patients administered glecaprevir/pibrentasvir. Of these, 1740 (48.5%) patients were infected with HCV GT 1, 765 (21.3%) patients were infected with HCV GT 2, 758 (21.1%) patients were infected with HCV GT 3, and 322 (9.1%) patients were infected with HCV GTs 4-6.…”

Section: Resultsmentioning

confidence: 99%

“…SVR12 rates in patients without cirrhosis were described in 14 phase III clinical trials (NCT02707952, 3 NCT02723084, 4 NCT02604017, 5 NCT02640482, 6 NCT02640157, 5 NCT02636595, 6 , 7 NCT02966795, 8 NCT02738138, 10 NCT02446717, 14 , 15 NCT03117569, 17 NCT02243293, 6 , 18 , 19 NCT03222583, 20 NCT03092375, 22 NCT03212521 23 ), including 3400 patients administered glecaprevir/pibrentasvir. SVR12 rates in patients with compensated cirrhosis were described in 8 phase III clinical trials (NCT02707952, 3 NCT02966795, 8 NCT02642432, 9 NCT02738138, 10 NCT03089944, 13 NCT02243293, 6 , 18 , 19 NCT03235349, 21 NCT03092375 22 ) including 923 patients administered glecaprevir/pibrentasvir.…”

Section: Resultsmentioning

confidence: 99%

“…SVR12 rates in DAA-naïve patients were described in 9 phase III clinical trials (NCT02707952, 3 NCT02723084, 4 NCT02604017, 5 NCT02640482, 6 NCT02640157, 5 NCT03089944, 13 NCT03117569, 17 NCT03212521, 23 NCT03219216 24 ), including 2,535 patients administered glecaprevir/pibrentasvir. SVR12 rates in DAA-experienced patients were described in 4 phase III clinical trials (NCT02707952, 3 NCT02604017, 5 NCT02640482, 6 NCT03092375 22 ), including 219 patients administered glecaprevir/pibrentasvir.…”

Section: Resultsmentioning

confidence: 99%

“…In 2017, 8-week glecaprevir/pibrentasvir was approved in the USA and Europe for patients infected with all HCV GTs without cirrhosis. Pooled data from 13 phase III clinical trials (NCT02604017, 5 NCT02640482, 6 NCT02640157, 5 NCT02636595, 6 , 7 NCT02642432, 9 NCT02651194, 11 NCT03089944, 13 NCT02446717, 14 , 15 NCT02692703, 16 NCT03117569, 17 NCT02243293, 6 , 18 , 19 NCT03092375, 22 NCT03212521 23 ) were included in an integrated efficacy analysis of 2818 patients infected with HCV GTs 1-6 administered glecaprevir/pibrentasvir for 8, 12 or 16 weeks. Findings showed that 97.5% (95% CI: 95.8-98.8%) and 97.8% (95% CI: 95.9-99.2%) of patients in the ITT population administered 8 or 12 weeks of glecaprevir/pibrentasvir, respectively, achieved SVR12 ( Fig.…”

Section: Resultsmentioning

confidence: 99%

See 4 more Smart Citations

Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis

Wang

Xiao

et al. 2020

Journal of Clinical and Translational Hepatology

View full text Add to dashboard Cite

Background and Aims: Glecaprevir/pibrentasvir is a pangenotypic regimen recently approved for the treatment of chronic hepatitis C virus (HCV) infection. The objective of the present review was to summarize the findings from clinical trials to understand how patient-related factors influence glecaprevir/pibrentasvir efficacy (sustained virologic response rates at 12 weeks' after treatment [referred to as SVR12]) and safety. Methods: Data from 21 phase III clinical trials were analyzed. Results: The integrated efficacy analysis included 4,817 patients. Findings showed 97.5% of all included patients with chronic HCV achieved SVR12 in the intention-to-treat population. SVR12 rate was >95% across subgroups of interest. The integrated safety analysis included 4,015 patients. Findings showed that 64.1% of patients reported an adverse event, and <0.1% of patients reported a serious adverse event related to glecaprevir/pibrentasvir. Conclusions: These results indicate that the 8-or 12-week glecaprevir/pibrentasvir treatment is effective for patients infected with HCV genotypes 1-6 without or with compensated cirrhosis, with good safety profiles, irrespective of treatmentexperience. Glecaprevir/pibrentasvir is a good option for patients with human immunodeficiency virus/HCV coinfection and comorbid HCV and severe renal impairment.

show abstract

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

See 3 more Smart Citations

Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis

Wang

Xiao

et al. 2020

Journal of Clinical and Translational Hepatology

View full text Add to dashboard Cite

show abstract

Liver cT1 decreases following direct-acting antiviral therapy in patients with chronic hepatitis C virus

et al. 2020

View full text Add to dashboard Cite

Purpose Direct-acting antiviral therapies (DAAs) for treatment of chronic hepatitis C virus (HCV) have excellent rates of viral eradication, but their effect on regression of liver fibrosis is unclear. The primary aim was to use magnetic resonance imaging (MRI) and spectroscopy (MRS) to evaluate changes in liver fibrosis, liver fat and liver iron content (LIC) in patients with chronic HCV following treatment with DAAs. Methods In this prospective study, 15 patients with chronic HCV due to start treatment with DAAs and with transient elastography (TE) > 8 kPa were recruited consecutively. Patients underwent MRI and MRS at baseline (before treatment), and at 24 weeks and 48 weeks after the end of treatment (EoT) for the measurement of liver cT1 (fibroinflammation), liver fat and T2* (LIC). Results All patients achieved a sustained virological response. Liver cT1 showed significant decreases from baseline to 24 weeks post EoT (876 vs 806 ms, p = 0.002, n = 15), baseline to 48 weeks post EoT (876 vs 788 ms, p = 0.0002, n = 13) and 24 weeks post EoT to 48 weeks post EoT (806 vs 788 ms, p = 0.016, n = 13). Between baseline and 48 weeks EoT significant reduction in liver fat (5.17% vs 2.65%, p = 0.027) and an increase in reported LIC (0.913 vs 0.950 mg/g, p = 0.021) was observed. Conclusion Liver cT1 decreases in patients with chronic HCV undergoing successful DAA treatment. The relatively fast reduction in cT1 suggests a reduction in inflammation rather than regression of fibrosis.

show abstract

HCV Viral Load Greater Than 1000 IU/ml at Time of Virologic Failure in Direct-Acting Antiviral-Treated Patients

et al. 2021

Self Cite

View full text Add to dashboard Cite

Introduction One of the remaining barriers to reaching WHO elimination targets of achieving global hepatitis C (HCV) cure is a lack of an established lower limit of detection (LLOD) to confirm cure post-treatment in near-patient technologies. Determining a LLOD at virologic failure aids in increasing testing feasibility through point-of-care assays in resource-limited settings. Methods We described the level of viremia in 69 patients experiencing virologic failure across 20 clinical trials (ENDURANCE-1, ENDURANCE-2, ENDURANCE-3, ENDURANCE-4, ENDURANCE 5–6, MAGELLAN-1, MAGELLAN-2, EXPEDITION-1, EXPEDITION-2, EXPEDITION-3, EXPEDITION-4, EXPEDITION-5, EXPEDITION-8, SURVEYOR-1, SURVEYOR-2, VOYAGE-1, VOYAGE-2, CERTAIN-1, CERTAIN-2 and APRI). These findings were categorized as on-treatment, post-treatment week (PTW) 4 or PTW12 failures. Results The mean HCV RNA level at baseline in the overall population of 5033 patients was 4,193,712 IU/ml ± 5,955,028 (6.2 log 10 IU/ml ± 0.8) compared to 9,585,957 IU/ml ± 8,247,669 (6.8 log 10 IU/ml ± 0.5) in 69 patients experiencing virologic failure by PTW12. The mean HCV RNA level at the time of virologic failure for all patients was 6,004,980 IU/ml ± 7,077,728 (6.4 log 10 IU/ml ± 0.7). Twenty patients had on-treatment virologic failure with a mean HCV RNA level at the time of failure of 9,136,360 IU/ml ± 8,572,113 (6.7 log 10 IU/ml ± 0.7), 36 patients had relapsed by PTW4 with a mean HCV RNA level at the time of relapse of 4,131,344 IU/ml ± 5,246,954 (6.3 log 10 IU/ml ± 0.6), and 13 patients, who experienced relapse between PTW4 and PTW12, had a mean HCV RNA at relapse of 6,376,003 IU/ml ± 7,758,968 (6.3 log 10 IU/ml ± 1.0). Conclusions At PTW12, 100% of virologic failures had an HCV RNA > 3.0 log 10 IU/ml. The data are encouraging that with a LLOD of 3.0 log 10 IU/ml, a point-of-care test could identify all treatment failures accurately; larger studies, including real-world data, are needed to confirm these findings.

show abstract

Efficacy and Safety of 8 Weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve, HCV-Infected Patients with APRI ≤ 1 in a Single-Arm, Open-Label, Multicenter Study

Cited by 9 publications

References 23 publications

Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis

Efficacy and Safety of Glecaprevir/Pibrentasvir for Chronic Hepatitis C Patients: A Systematic Review and Meta-analysis

Liver cT1 decreases following direct-acting antiviral therapy in patients with chronic hepatitis C virus

HCV Viral Load Greater Than 1000 IU/ml at Time of Virologic Failure in Direct-Acting Antiviral-Treated Patients

Contact Info

Product

Resources

About