Efficacy and Benefits of Shorter Treatment of GlicaprivirPibentrasvir in HCV Related Chronic Hepatitis: Results from an Italian Real Life Study
Received: 05-May-2021 Accepted Date: May 20, 2021 ; Published: 31-May-2021
Citation: Persico M. Efficacy and Benefits of Shorter Treatment of Glicaprivir-Pibentrasvir in HCV Related Chronic Hepatitis: Results from an Italian Real Life Study. J Basic Clin Pharma.2021;12(4):43
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Direct-acting Antivirals Agents (DAAs) represented a real revolution in the treatment of patients with Hepatitis C Virus (HCV) chronic infection. The use of these drugs has allowed the achievement of eradication rates of the disease close to 100%, associated to an excellent safety profile, an extreme ease of administration (oral route) and shortness of treatment . In particular, glecaprevir/pibrentasvir combination, a pangenotypic regimen, effective and safe even in patient with advanced Chronic Kidney Disease (CKD), has allowed the reduction of treatment to only 8 weeks .
The MISTRAL study is a prospective, longitudinal multicenter study evaluating antiviral efficacy and safety of glecaprevir/pibrentasvir combination in a real-life setting. We enrolled 1177 HCV infected patients consecutively treated in 22 liver centers of Southern Italy; 583 were males, with a median age of 62 years. The most common genotypes were 1b (37%) and 2 (35%). One hundred nine patients had cirrhosis and 88 patients had METAVIR Score F3; 28 patients had an end stage renal disease and 118 patients were drug users. The sustained virology response was higher than 99%, independently from gender, liver fibrosis, previous treatment, CKD stage, and treatment duration and drug abuse. The only baseline clinical factors discriminating between treatment success and treatment failure were identified in the age at treatment (p = 0.031) and the creatinine level (p = 0.034); genotype 3 seemed to be associated to a treatment failure (45.5%) than the other genotypes (χ2 = 0.005). One of the most relevant points of this study is the demonstration of efficacy in patients who use drugs; in fact, no difference was noted between patients who have used substances compared to the population who do not use them in a real-life condition. This is particularly important considering the social (as well as individual) usefulness of the treatment of drug users. This population is considered to be at a higher risk of infection transmission, so effectively treating this group of patients is critical to achieving the elimination of chronic HCV infection worldwide.
In the MISTRAL study 60 patients reported at least one adverse event related to therapy, the most common of which was itching, followed by fatigue. These data are in line with those highlighted in clinical trials, so the glecaprevir/pibrentasvir combination has proven safe even in a real-life study.
Despite the presence of some limitations, such as the retrospective nature of the study, and the general “well-being” of the study population enrolled, the MISTRAL study was the first to show the effectiveness and safety of the glecaprevir/pibrentasvir combination in a real-life scenario in a highly epidemic HCV area in southern Italy.
In conclusion this real life study documented, according to the registered trials, the efficacy and very high tolerability of glicaprivir-pribentasvir combination in patients with HCV-related chronic hepatitis. Moreover, the shortest eight weeks treatment was useful to reach a 99% HCV elimination as well as the 12 weeks one. The study also represented one of the first evidence, in a small number of patients who underwent to an off label therapy regimen, that the shorter treatment regimen showed effective in cirrhotic patients. Eight weeks prescription of pangenotipic glicaprivir-pibrentasvir antiviral combination may be considered in all the HCV infected patients with all the different stages of the disease but decompensated cirrhosis.