Glecaprevir and Pibrentasvir Results in High Sustained Virologic Response in Older Patients With HCV

The SVR rates remained consistently high after the investigators conducted a subgroup analysis stratified by genotype, treatment duration, fibrosis stage, and concomitant medications.

Glecaprevir and Pibrentasvir Results in High Sustained Virologic Response in Older Patients With HCV

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Treatment with glecaprevir and pibrentasvir for elderly patients with chronic hepatitis C virus (HCV) is both safe and efficacious, resulting in extremely high rates of sustained virologic response (SVR).1

A team, led by Nicola Pugliese, Division of Internal Medicine and Hepatology, Department of Gastroenterology, IRCCS Humanitas Research Hospital, analyzed the efficacy and safety of glecaprevir and pibrentasvir in Caucasian patients with chronic HCV aged 75 years and older.

The Medicine

Treatment glecaprevir and pibrentasvir have led to high rates of SVR in patients with chronic HCV infections, without sacrificing safety.

In the retrospective multicenter real-world study, the investigators examined all consecutive patients aged 75 years and older who were treated with glecaprevir and pibrentasvir between October 2017 and January 2022 at 5 referral centers in Italy. The investigators analyzed SVR by intention-to-treat and per-protocol analyses.

The study included 570 patients with a mean age of 80 years. At the time of enrollment, 52% (n = 298) of patients had HCV-1, 44% (n = 252) had HCV-2, and 24% (n = 137) had liver cirrhosis. In addition, 81% (n = 463) of patients were taking at least 1 concomitant drug, with 25% (n = 144) taking at least 5 concomitant drugs. Overall, 86% (n = 488) of patients were treated with glecaprevir and pibrentasvir for 8 weeks.

Safety and Efficacy

The results show only 8% (n = 48) reported side effects due to the treatment and 2% (n = 10) of patients discontinued treatment prematurely, while 2 patients development serious adverse events that weren’t considered to be related to the treatment.

Overall, 97.9% (n = 558) of patients achieved SVR by the intention-to-treat analysis and 99.6% (n = 558) achieved SVR by the per-protocol analysis.

The SVR rates remained consistently high after the investigators conducted a subgroup analysis stratified by genotype, treatment duration, fibrosis stage, and concomitant medications.

“Treatment with G/P achieved 97.9% SVR rates in HCV patients older than 75 years of age,” the authors wrote. “Safety was optimal with only 2% of patients discontinuing early.”

Other Data

Recent data has pointed to efficacy and safety for glecaprevir and pibrentasvir.2

A 2021 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.

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.

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-treatment.

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.

References:

1. Pugliese, N., Calvaruso, V., Masarone, M., D’Ambrosio, R., Battistella, S., Licata, A., Persico, M., Anolli, M. P., Distefano, M., Petta, S., Russo, F. P., Di Marco, V., & Aghemo, A. (2023). Glecaprevir/Pibrentasvir is safe and effective in Italian patients with chronic hepatitis C aged 75 years or older: A Multicentre study. Liver International. https://doi.org/10.1111/liv.15599

2. Alicea, J. (2021, May 27). Glecaprevir/Pibrentasvir for HCV safe in real word and clinical settings. HCP Live. https://www.hcplive.com/view/glecaprevir-pibrentasvir-hcv-safe-real-word-clinical-settings

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