Glecaprevir / Pibrentasvir for HCV Safe in Real World and Clinical Settings
A new study indicates that glecaprevir / pibrentasvir may be safe in patients with hepatitis C virus (HCV) eligible for treatment by non-hepatic specialists.
Through simplified pre-treatment assessment and guidelines, laypersons can play a role in the care and treatment of HCV-infected patients.
“Governing bodies recently published simplified treatment algorithms that may facilitate wider acceptance of treatment in primary care settings, thereby reducing gaps in the cascade of care,” the researchers wrote. “These algorithms help identify easy-to-treat patients with less advanced liver disease or at low risk of negative liver-related results.”
The investigative team, led by Xavier Forns, MD, University of Barcelona, performed a post hoc analysis using data from actual trials in various countries as well as relevant clinical trials. As such, they verified the safety profile of glecaprevir / pibrentasvir for a large patient population.
All patients who could be managed by non-hepatic specialists were included in the analysis, while those with non-severe and non-advanced hepatic disease were excluded.
In real world studies and clinical trials, patients took 300 or 120 mg of glecaprevir / pibrentasvir per day with food for 8, 12, or 16 weeks. In the 16 clinical trials of interest, patients were followed for 24 weeks after treatment.
Overall, SVR12 rates were ≥ 97.5% in the intention-to-treat clinical trial cohort, which met baseline criteria FIB-4 9/ L, albumin> 38 g / L and platelet count ≥ 130 × 109/ L, or more than one basic characteristic.
Additionally, 97.6% of baseline real-world studies patients, who also met the same criteria above, experienced SVR12. There was no difference between the baseline endpoint cohorts.
“Overall, in the clinical trial cohort, 60.6% (2275/3754) experienced an AE, while 31.5% (1184/3754) and 0.3% (10/3754) of patients experienced an AE possibly related to the study drug and an AE leading to treatment discontinuation, respectively, ”Forns and colleagues reported.
In the real world cohort, “13.8% (187/1352) of patients presented with an AE, with 7.8% (106/1352) and 0.4% (6/1352) of patients presenting with possibly an AE. study drug-related and one AE leading to discontinuation, respectively. “
The most frequently reported adverse events in the clinical trial cohort were headache (13.2%), fatigue (10.0%), and nausea (10.0%). The most common events leading to discontinuation of treatment were angioedema (
In the real population, the most common events were fatigue (2.5%), asthenia (2.4%) and headache (2.2%), with nausea (0.1%) being the most common event leading to discontinuation of treatment.
These results were consistent across all baseline endpoint groups, with no apparent difference in the number of adverse events, treatment-related adverse events, or serious adverse events seen in the clinical trial or in actual cohorts.
“These data should provide reassurance that specialized intervention is not needed for low-risk patients and strengthen the wider adoption of non-invasive screening tools in primary care settings,” the investigators wrote. “Non-hepatic specialists can be reassured that G / P, when prescribed according to the label, can be used safely in patients in conjunction with post-SVR HCC screening and drug interaction awareness. potential. “
As such, expanding the pool of treatment providers may ultimately help meet HCV elimination goals, said Forns and colleagues.
The study “Safety of patients with hepatitis C virus treated with glecaprevir / pibrentasvir from clinical trials and real-world cohorts” has been published online in Advances in therapy.