Daclahep is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults
U.S. Food and Drug Administration approved Daclahep (Daclatasvir) for use with sofosbuvir to treat hepatitis C virus (HCV) genotype 3 infections on July 24, 2015 . Daclatasvir is the first drug that has demonstrated safety and efficacy to treat genotype 3 HCV infections without the need for co-administration of interferon or ribavirin, two FDA-approved drugs also used to treat HCV infection.
Daklinza is presently marketed by Bristol-Myers Squibb. (BMS)
Peak daclatasvir concentrations were generally observed approximately 1 to 2 hours post-dose.
Administration of a high-fat meal reduced Cmax and AUC by 28% and 23%, respectively.
Administration of a light meal did not influence daclatasvir exposure. Daclatasvir exposure HCV
infected subjects appeared to be lower than those observed in healthy volunteers at repeated
doses from 1 to 30 mg, but similar at 60 mg.
Avoid taking an antacid within 4 hours before or 4 hours after you take Harvoni. This especially includes antacids that contain aluminum or magnesium (Acid Gone, Aldroxicon, Alternagel, Di-Gel, Gaviscon, Gelusil, Genaton, Maalox, Maldroxal, Milk of Magnesia, Mintox, Mylagen, Mylanta, Pepcid Complete, Rolaids, Rulox, and others).
Taking this medication will not prevent you from passing hepatitis C to other people. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HCV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Daclatasvir is generally well tolerated with no known specific side-effects of its own. The most common side-effects seen in people taking daclatasvir with sofosbuvir are fatigue, nausea and headache.
Taking daclatasvir with interferon and ribavirin can lead to additional side-effects including fever, muscle and joint aches, itching, depression, anaemia (low haemoglobin level) and neutropenia (low white blood cell count). Ribavirin can also cause birth defects, so it should not be used by pregnant women or their male partners.