FDA Approves Labeling Update for Several HCV Drugs

Updated labeling has been provided for several treatments for hepatitis C virus infections.

The Food and Drug Administration (FDA) has approved updated labeling for several hepatitis C virus (HCV) infection treatments.

Specifically, the prescribing information for Viekira Pak (ombitasvir, paritaprevir, ritonavir, with dasabuvir; AbbVie), Viekira XR (dasabuvir, ombitasvir, paritaprevir, ritonavir; AbbVie), Technivie (ombitasvir, paritaprevir, ritonavir; AbbVie), Sovaldi (sofosbuvir; Gilead), Harvoni (ledipasvir, sofosbuvir; Gilead), Epclusa (sofosbuvir, velpatasvir; Gilead), Vosevi (sofosbuvir, velpatasvir, voxilaprevir; Gilead), Olysio (simeprevir; Janssen), Daklinza (daclatasvir; Bristol-Myers Squibb), and Zepatier (elbasvir, grazoprevir; Merck) has been updated to include information pertaining to changes in International Normalized Ratio (INR) values in patients receiving warfarin. Fluctuations in INR values may occur in patients receiving warfarin concomitant with HCV treatment.  If coadministration is necessary, frequent monitoring of INR values is recommended during treatment as well as post-treatment follow-up.

In addition, the labeling for Harvoni, Epclusa, and Vosevi was updated to include drug interaction information regarding the concomitant use of these agents with atorvastatin as coadministration may be associated with increased risk of myopathy, including rhabdomyolysis. In these patients, close monitoring of HMG-CoA reductase inhibitor-associated adverse reactions is recommended. 

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Drugs@FDA: FDA Approved Drug Products. Silver Springs, MD: US Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm. Accessed November 21, 2017. 

This article originally appeared on MPR