Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil

Peribañez-Gonzalez, Mario; Cheinquer, Hugo; Rodrigues, Lino; Lima, Maria Patelli Juliani Souza; Álvares‐da‐Silva, Mário Reis; Madruga, José Valdez; Parise, Edison Roberto; Furtado, Juvencio; Villanova, Márcia G.; Ferreira, Adalgisa P.; Mazzoleni, Felipe; Nascimento, Écio Alves; Silva, Giovanni Faria; Fredrick, Linda; Krishnan, Preethi; Burroughs, Margaret; Reuter, Tânia

doi:10.1016/j.aohep.2020.09.002

Cited by 8 publications

(14 citation statements)

References 13 publications

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“…It is important to note that patients included in this analysis had evidence of PHT but no current decompensation events. Additionally, patients with severe PHT (platelets\50,000-60,000 cells/mm 3 ), patients who had decompensated cirrhosis (Child-Pugh scores [7) or ALT or AST[10 9 ULN were excluded from the trials included in this analysis [6,[8][9][10][14][15][16][17][18][19]. The generalizability of the data presented here obtained from clinical trials may need to be considered in relation to settings where PHT is assessed through alternative methods of testing.…”

Section: Discussionmentioning

confidence: 99%

“…All trial protocols upon which this post hoc analysis was based were approved by the independent ethics committees or institutional review boards at all the trial centers. All the trials were conducted in accordance with Good Clinical Practice Guidelines and the ethical principles of the Declaration of Helsinki, all participants provided written informed consent and parents/guardians provided consent where required, and study participants provided consent where required [6,[8][9][10][14][15][16][17][18][19].…”

Section: Study Design and Patient Populationmentioning

confidence: 99%

“…The study designs, patient populations, and outcomes of the trials included in this analysis have been published previously [8][9][10][14][15][16][17][18][19]. In brief, patients were TN, infected with chronic HCV genotypes (GT)1-6, and had CC.…”

Section: Study Design and Patient Populationmentioning

confidence: 99%

“…CC was defined by liver biopsy [METAVIR fibrosis stage F4 (or equivalent)], transient elastography (FibroscanÒ, Echosens, France) C 14.6 kPa, a FibroTest (BioPredictive, Paris, France) score of C 0.75, and an aspartate aminotransferase (AST)-toplatelet ratio index (APRI) of[2, a Child-Pugh score of 6 or less at screening, and no current or past evidence of Child-Pugh B or C classification or clinical history of liver decompensation. Absence of HCC was confirmed at or within 3 months prior to screening by a negative ultrasound, computed tomography scan, or magnetic resonance imaging [6,[8][9][10][14][15][16][17][18][19].…”

Section: Endpoints and Assessmentsmentioning

confidence: 99%

“…Safety outcomes were also assessed. In all the studies, all treatment-emergent adverse events (AEs), defined as any AE with an onset date after the first dose of G/P and no more than 30 days after the last G/P dose, were monitored and were either coded using the Medical Dictionary for Regulatory Activities v.23.1 Preferred Terms or mapped onto this version for the integrated data analysis [6,[8][9][10][14][15][16][17][18][19]. For this analysis, we were focused on differences in SVR12 between 8 and 12 weeks in PHT patients, as well as on differences in safety between PHT and non-PHT groups.…”

Section: Endpoints and Assessmentsmentioning

confidence: 99%

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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: 99%

Section: Study Design and Patient Populationmentioning

confidence: 99%

Section: Study Design and Patient Populationmentioning

confidence: 99%

Section: Endpoints and Assessmentsmentioning

confidence: 99%

Section: Endpoints and Assessmentsmentioning

confidence: 99%

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

et al. 2021

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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.

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Antiviral drugs

Samuel¹,

McNaught²,

Mulbah³

et al. 2022

Side Effects of Drugs Annual

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Efficacy and safety of glecaprevir/pibrentasvir in treatment-naïve adults with chronic hepatitis C virus genotypes 1–6 in Brazil

Cited by 8 publications

References 13 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

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

Antiviral drugs

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