New clinical data indicates that a major form of medication has a massive impact on a prominent virus.
AbbVie’s late-stage information demonstrates that the ribavirin-free hepatitis C therapy glecaprevir/pibrentasvir has achieved high cure rates across the majority of patients infected with the virus.
Glecaprevir/pibrentasvir is a once-daily regimen that combines two distinct antiviral agents.
Both the NS3/4A protease inhibitor glecaprevir (300mg) and NS5A inhibitor pibrentasvir (120mg) are involved in the treatment, with patients requested to consume the medicine orally.
In a recently conducted study, 99% of chronic hepatitis C virus infected patients with genotypes 1, 2, 4, 5 or 6 and compensated cirrhosis achieved sustained virologic response at 12 weeks post-treatment after consuming the treatment prepared by AbbVie.
It was also notable that high SVR12 rates were experienced by patients after 12 weeks of glecaprevir/pibrentasvir treatment without ribavirin.
In order to ensure that results were as legitimate as possible, strains that are typically associated with high resistance were included in the study, as were those with a high quantity of the virus in the bloodstream before treatment.
Researchers noted that adverse events observed were mild in nature, with all participants completing the study.
Some patients did complain of fatigue and headaches, but even these minimal side-effects were only found in 10% of respondents.
Xavier Forns, head of hepatitis unit, Hospital Clinic de Barcelona, suggested that the results represented another step forward in the treatment of HCV patients.
“We have already seen great progress in the treatment of HCV patients with compensated cirrhosis. However, treatment challenges remain related to the use of ribavirin. The positive findings from the EXPEDITION-1 study, along with previously reported data, show that glecaprevir/pibrentasvir has the potential to become a ribavirin-free treatment for patients with compensated cirrhosis across these genotypes.”
In an attempt to ensure that the drug becomes widely available, ,arketing applications for glecaprevir/pibrentasvir are currently under review by regulatory authorities across the globe.
The treatment has been granted accelerated assessment by the European Medicines Agency, and priority review designations by the USA Food and Drug Administration and Japanese Ministry of Health, Labour and Welfare.
According to AbbVie, the glecaprevir/pibrentasvir regimen could provide a shorter, eight week, once-daily, ribavirin-free treatment option for the majority of HCV patients without cirrhosis, as well as an additional treatment option to patients with compensated cirrhosis.