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Specialist intervention is likely not necessary for low-risk patients; and so, non-liver specialists can be reassured of G/P’s safety profile.
A new study indicates that glecaprevir/pibrentasvir may be safe in patients with hepatitis C virus (HCV) eligible for treatment by non-liver specialists.
As a result of simplified pretreatment assessment and guidelines, non-specialists are able to play a role in the management and treatment of HCV-infected patients.
“Guideline bodies have recently released simplified treatment algorithms that may facilitate wider treatment acceptance within primary care settings, thus reducing care cascade gaps,” the investigators wrote. “These algorithms help identify easy-to-treat patients with less advanced liver disease or at low risk for negative liver-related outcomes.”
The investigative team, led by Xavier Forns, MD, University of Barcelona, performed a post hoc analysis utilizing data from real-world trials across various countries as well as relevant clinical trials. As such, they ascertained the safety profile of glecaprevir/pibrentasvir for a large patient population.
All patients who could be managed by non-liver specialists were included in the analysis, while those with non-severe and non-advanced liver disease were excluded.
In both real-world studies and clinical trials, patients took 300 or 120 mg of glecaprevir/pibrentasvir daily with food for 8, 12, or 16 weeks. In the 16 clinical trials of interest, patients were followed for 24 weeks post-treamtent.
Overall, SVR12 rates were ≥97.5% in the intent-to-treat clinical trial cohort, who met criteria of baseline FIB-4 < 3.25, FibroScan < 20 kPa and platelet count ≥ 150 × 109/L, albumin > 38 g/L and platelet count ≥ 130 × 109/L, or more than 1 baseline characteristic.
Additionally, 97.6% of core patients from the real world studies, who also met the same aforementioned criteria, demonstrated SVR12. There were no differences between the baseline criteria 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 experienced an AE, with 7.8% (106/1352) and 0.4% (6/1352) of patients experiencing an AE possibly related to the study drug and an AE leading to treatment discontinuation, respectively.”
The most commonly 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 treatment discontinuation were angioedema (<0.1%), anxiety (<0.1%), and nausea (<0.1%).
Among the real world 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.
These findings were consistent across all baseline criteria groups, with no apparent differences in number of adverse events, treatment-related adverse events, or serious adverse events observed within either the clinical trial or real-world cohorts.
“These data should provide reassurance that specialist intervention is not necessary for low-risk patients and reinforce the wider adoption of noninvasive screening tools in primary care settings,” the investigators wrote. “Non-liver specialists can be reassured that G/P, when prescribed per label, can be safely used in patients in combination with post-SVR HCC screening and awareness of potential drug–drug interactions.”
As such, expanding the treatment provider pool may ultimately help with the meeting of HCV elimination targets, Forns and colleagues indicated.
The study, “Safety of Patients with Hepatitis C Virus Treated with Glecaprevir/Pibrentasvir from Clinical Trials and Real-World Cohorts,” was published online in Advances in Therapy.