Glecaprevir/pibrentasvir found to be effective in clinical trials treating patients with hepatitis C virus also being treated for opioid substitution therapy.
With the opioid epidemic continuing to spread across America, so too has the amount of hepatitis C virus (HCV) infections resulting from sharing of injection equipment. Following the launch of new direct-acting antiviral (DAA) regimens, the goal of eliminating HCV infection is within reach.
The coformulated DAAs glecaprevir/pibrentasvir (G/P) were approved in Europe for the treatment of adult patients with HCV genotype (GT) 1-6 infection. Although proven 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.
The analysis included adult patients 18 years and older with chronic HCV GT1-6 infections, without cirrhosis or with compensated cirrhosis, who were naïve or experienced with PRS and who had been treated with G/P according to the European Medicines Agency (EMA) label.
The investigators compared patients on opioid substitution therapy 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). The researchers 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 HCV 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.
The article was originally published by MD Magazine.
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