AbbVie’s new medication for the hepatitis C virus (HCV) seeks to cure the disease more quickly and at a lower cost in several hard-to-treat populations.
The FDA has approved glecaprevir/pibrentasvir (Mavyret), an eight-week, pan-genotypic treatment for HCV patients with compensated cirrhosis or without cirrhosis who are new to treatment. Evercore ISI analyst Umer Raffat cited an anticipated price of $26,400 for the eight-week treatment, undercutting competing regimens. For example, the gross price of ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) is about $63,000 for eight weeks, he said. Still, he warned that the true costs of all the HCV medications are likely to be dictated by discounts, which in the case of Harvoni bring the net price to about $30,000.
The FDA’s approval is supported by an overall 98% cure rate (rates ranged between 92% and 100%) in patients who received the recommended duration of treatment. Patients who achieve a sustained virologic response at 12 weeks post-treatment are considered cured. The treatment for genotypes 1 to 6 is approved for use in patients across all stages of chronic kidney disease (CKD) and may be used in up to 95% of HCV patients, depending on stage of liver disease and prior treatment history.
An estimated 500,000-plus people have both chronic HCV and CKD. Mavyret was designed to deliver a cure across all major genotypes and specific treatment challenges, such as patients with severe CKD, and genotype 1 patients not cured by a NS5A inhibitor or a NS3/4A protease inhibitor direct-acting antiviral (DAA) treatment, but not both. Mavyret combines two new DAAs that target and inhibit proteins essential for the replication of HCV.
The approval of Mavyret is supported by data from nine registrational studies in AbbVie's clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes (GT1-6) and special populations.
The ribavirin-free treatment for adults combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A inhibitor, dosed once-daily as three oral tablets, taken with food. The most common side effects are headache and tiredness.