Glecaprevir/Pibrentasvir Safe & Effective in Patients with Hepatitis C Virus On Opioid Substitution Therapy

As the opioid epidemic continues to expand, so does the number of hepatitis C virus infections due to the sharing of injection equipment. With the advent of direct-acting antiviral (DAA) regimens, the goal of eliminating hepatitis C virus infection is within reach.

The coformulated DAAs glecaprevir/pibrentasvir (G/P) were approved in Europe for the treatment of adult patients with hepatitis C genotype (GT) 1-6 infection. Although they proved highly effective in clinical trials, there are limited data pertaining to the real-world use of G/P in patients on opioid substitution therapy.

At the 2018 Annual ID Week Meeting held this year in San Francisco, California, investigators reported the first real-world data of G/P in this population, showing favorable safety and effectiveness, with no discontinuations due to adverse events.

For the ongoing, non-interventional, multicenter, prospective registry study, referred to as the German Hepatitis C-Registry, the investigators collected data from July 28, 2017, to February 9, 2018, spanning 104 sites throughout Germany.

Adult patients 18 years and older with chronic hepatitis C virus GT1-6 infections, without cirrhosis or with compensated cirrhosis, who were naïve or experienced with PRS who had been treated with G/P according to the European Medicines Agency (EMA) label were included in the analysis.

The investigators compared patients on opioid substitution therapy who were treated with G/P with patients who were not on opioid substitution therapy for 8, 12, or 16 weeks according to the EMA label. The primary endpoint of the study was sustained virologic response at 12 weeks post-treatment (SVR12). They evaluated the safety and tolerability of G/P in patients who completed treatment.

A total of 638 patients initiated on-label G/P treatment and were included in the baseline analysis, as of February 9, 2018. Twenty-six percent (168/638) of the baseline population were patients on opioid substitution therapy; most of these patients were treatment-naïve, without cirrhosis, and were infected with hepatitis C virus genotype 1a or 3.

Ninety-six percent (27/28) of patients on opioid substitution therapy and 97% of patients who were not achieved SVR12, based on available data. The investigators did not observe any virologic failures; however, there were 3 early discontinuations of treatment. One patient on opioid substitution therapy was lost to follow-up and 2 patients who were not on opioid substitution therapy stopped treatment because they experienced adverse events (AEs).

SVR12 was 100% for both patients on opioid substitution therapy and patients who were not in the modified intention-to-treat population which excluded non-virologic failures. According to the investigators, the safety population consisted of 321 patients. Of the patients on opioid substitution therapy, only 2% (2/84) were observed to have serious AEs but they did not have any treatment discontinuations due to AE/SAEs.

Thus far, data yielded from the real-world analysis suggests that G/P treatment is safe and effective in patients on opioid substitution therapy, the authors concluded. Updated data and SVR12 results will be presented as the information becomes available.

Disclosures:

J. Reimer, AbbVie, Bristol-Myers Squibb, Gilead, Janssen-Cilag, MSD: Board Member and Scientific Advisor, Educational grant and Speaker honorarium

A. Stoehr, AbbVie, Gilead, Janssen, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium

U. Naumann, AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Mundipharma, MSD, Roche, ViiV: Board Member, Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium

G. Teuber: AbbVie, BMS, Janssen, Gilead, MSD: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium

C. Zamani, AbbVie Inc: Board Member and Scientific Advisor, Consulting fee

S. Mauss, AbbVie, Gilead, Falk, Janssen, MSD: Scientific Advisor and Speaker's Bureau, Consulting fee and Speaker honorarium

N. Qurishi, AbbVie, Gilead, Janssen, MSD, ViiV, Mundipharma, Hexal: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium

K. Lohmann, AbbVie Inc: Employee and Shareholder, Salary and Stock and/or options

H. Kleine, AbbVie Inc: Employee and Shareholder, Salary and Stock and/or options

A. Pangerl, AbbVie Inc: Employee and Shareholder, Salary and Stock and/or options

S. Christensen, AbbVie, Gilead, Indivior, Janssen-Cilag, MSD, ViiV: Consultant and Scientific Advisor, Consulting fee and Speaker honorarium.