Glecaprevir/Pibrentasvir Efficacious for HCV in Highly Endemic Areas

hepatitis C virus, HCV
hepatitis C virus, HCV
Researchers found data from that showed the once-daily, direct-acting antiviral regimen, glecaprevir co-formulated with pibrentasvir, is effective and safe in hepatitis C.

According to study results published in Liver International, glecaprevir/pibrentasvir (GLE/PIB) is efficacious for the treatment of hepatitis C virus (HCV) in highly endemic areas.1

GLE/PIB is a recently approved pan-genotypic regimen that has demonstrated a 98% rate of sustained virologic response (SVR) at post-treatment week 12 in more than 2200 patients in phase 2 and 3 clinical trials across all six major HCV genotypes.2-7 However, there are few data on GLE/PIB in a field-practice scenario, which can provide evidence for drug efficacy and identify potential predictors of treatment failure or relapse in currently underserved populations, including people who inject drugs (PWID) and people with decompensated cirrhosis.1 Researchers in Italy conducted a study in 1177 patients to assess real-life efficacy and safety of GLE/PIB and identify predictive factors for treatment. Of  this population, 123 patients (10%) were infected with HCV genotype 3, 104 (9%) had cirrhosis (defined as a METAVIR fibrosis score F4), and 118 (10%) were PWID. Overall, 99% of patients (1163/1177) achieved SVR. Baseline clinical factors that discriminated between treatment success and nonresponse were age at treatment and creatinine level. However, gender, substance abuse, previous treatment, treatment duration, fibrosis, or chronic kidney disease stage did not influence SVR rates. Of note, patients with PWID exhibited a significantly different genotype pattern distribution compared with non-substance abusers. Serious adverse events were only reported by 6 patients (0.5%).

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“In conclusion, the MISTRAL study provides first evidence of GLE/PIB efficacy in a field-practice scenario in a highly epidemic HCV area in southern Italy and unveiled significant differences in genotype distribution among the most underserved and difficult-to-treat patient subgroups including PWID and patients in the F4 group harbouring HCV3 genotype” stated the researchers.1

1. Persico M, Aglitti A, Milella M, et al. Real-life glecaprevir/pibrentasvir in a large cohort of patients with hepatitis C virus infection: The MISTRAL study [published online June 7, 2019]. Liver Int. doi:10.1111/liv.14170

2. D’Ambrosio R, Pasulo L, Puoti M, et al. Real-life effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C [published online November 23, 2018]. J Hepatol. doi:10.1016/j.jhep.2018.11.011

3. Foster GR, Dore GJ, Wang S, et al. Glecaprevir/pibrentasvir in patients with chronic HCV and recent drug use: An integrated analysis of 7 phase III studies. Drug Alcohol Depend. 2018;194:487-494.

4. Osawa M, Imamura M, Teraoka Y, et al. Real-world efficacy of glecaprevir plus pibrentasvir for chronic hepatitis C patient with previous direct-acting antiviral therapy failures [published online October 17, 2018]. J Gastroenterol. doi:10.1007/s00535-018-1520-9

5. Zeuzem S, Foster GR, Wang S, et al. Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med. 2018;378:354-369.

6. Asselah T, Kowdley KV, Zadeikis N, et al. Efficacy of glecaprevir/pibrentasvir for 8 or 12 weeks in patients with hepatitis C virus genotype 2, 4, 5, or 6 infection without cirrhosis. Clin Gastroenterol Hepatol. 2018;16:417-426.

7. Forns X, Lee SS, Valdes J, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5 or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicenter phase 3 trial. Lancet Infect Dis. 2017;17:1062-1068.