The higher cure rate of treating hepatitis C patients with a combination of ledipasvir and sofosbuvir (Harvoni) led to substantially better work productivity, according to a new study. In fact, improved work productivity and lack of absenteeism could save the United States and 5 European countries more than $3.2 billion a year.
The cost of treating people infected with the hepatitis C virus (HCV) with newly approved therapies is likely to place a tremendous economic burden on the country’s healthcare system, according to a study published in the March 17 issue of the Annals of Internal Medicine.
There is plenty of activity already in the hepatitis C market as competition has arrived for 2015, including CVS Health versus Express Scripts and Gilead Sciences versus AbbVie, over FDA-approved hepatitis C treatments. This will have implications for retail prescriptions as well as continuity-of-care programs within non-Medicare accountable care organizations (ACOs) and health systems.
FDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).
The new combination hepatitis C drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) has been found to be highly effective in treating patients with cirrhosis who have not benefited from previous therapies.
Bristol-Myers Squibb (BMS) will not pursue FDA approval of its hepatitis C (HCV) treatment, a dual regimen of daclatasvir and asunaprevir, and has withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.