icon-folder.gif   Conference Reports for NATAP  
  19th International Workshop on
Clinical Pharmacology of Antiviral Therapy
May 22, 2018
Baltimore, USA | Baltimore Marriott Inner Harbor
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Glecaprevir/pibrentasvir SVR12 at 97% regardless of psychiatric disorders
  19th International Workshop on Clinical Pharmacology of Antiviral Therapy
Mark Mascolini
One third of participants in 10 trials of the direct-acting antiviral coformulation glecaprevir/pibrentasvir (G/P) had a psychiatric disorder [1]. But their cure rate 12 weeks after therapy ended (SVR12) equaled that of people without a psychiatric disorder: 97%.
Mavyret combines the HCV NS3/4A protease inhibitor glecaprevir with the NS5A inhibitor pibrentasvir in a single tablet, 3 of which are taken once daily for a combined G/P dose of 300/120 mg. In phase 2 and 3 trials, G/P attained SVR12 rates of 97% or higher across HCV genotypes 1 through 6 [2,3].
Because prevalence of psychiatric disorders is higher in people with HCV than in the general population, David Back (University of Liverpool) and colleagues at other centers analyzed data from 10 phase 2 or 3 studies, comparing participants with and without a psychiatric disorder. The investigators pooled data from 2 SURVEYOR trials, 1 MAGELLAN trial, 4 ENDURANCE trials, and 3 EXPEDITION trials. They identified people with a psychiatric disorder as those taking a psychiatric medication when starting G/P or those with a history of a psychiatric disorder. The investigations used intention-to-treat analysis to assess the proportion of patients with versus without a psychiatric disorder who achieved SVR12.
The analysis included 2522 people with HCV, 789 of them (31%) with a psychiatric disorder. The most frequent disorders were depression (64%), anxiety (47%), and bipolar disorder (7%), and disorders occurred more often in whites (87%) and people older than 65 (89%). Among people being treated for a psychiatric disorder, 50% took antidepressants, 34% opioids, 31% anxiolytics, 28% antiepileptics, 20% sedative/hypnotics, and 15% antipsychotics.
In people with a psychiatric disorder, overall SVR12 stood at 97.3% (95% confidence interval [CI] 96.2% to 98.5%), compared with 97.5% in people without a psychiatric disorder (95% CI 96.7% to 98.2%). SVR12 stood above 96% in people with a psychiatric disorder regardless of how many diagnosed disorders they had or how many psychiatric drugs they took.
No one with a psychiatric disorder had a glecaprevir- or pibrentasvir-related serious adverse event, and only 5 of 789 (under 1%) had an adverse event that made them stop G/P.
EASL: Integrated Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients With Psychiatric Disorders - (04/13/18)
1. Back D, Belperio P, Bondin M, et al. Integrated efficacy and safety of glecaprevir/pibrentasvir in patients with psychiatric disorders. 19th International Workshop on Clinical Pharmacology of Antiviral Therapy. May 22-24, 2018. Baltimore. Abstract 24.
2. Aghemo A, Colombo M. Glecaprevir/pibrentasvir: the final piece in the hepatitis C virus treatment puzzle? Gastroenterology. 2018;154:1195-1196.
3. Carrion AF, Martin P. Glecaprevir + pibrentasvir for treatment of hepatitis C. Expert Opin Pharmacother. 2018;19:413-419.