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# Class Labeling Changes to 9 Hepatitis Drugs
- URL: https://www.fdaweb.com/class-labeling-changes-to-9-hepatitis-drugs/
- Published: 2017-02-14T12:00:00.000Z
- Updated: 2026-09-14T22:06:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137979

FDA has approved class labeling revisions about the risk of hepatitis B virus (HBV) in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus. An agency [notice](https://content.govdelivery.com/accounts/USFDA/bulletins/18741e2s:?ref=fdaweb.com) says the labeling changes include: 

- test all patients for evidence of current or prior HBV infection before starting treatment with HCV direct-acting antiviral drugs (DAAs);
- in patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment and during post-treatment follow-up; and
- initiate appropriate patient management for HBV infection as clinically indicated.

The changes apply to Bristol-Myers Squibb’s Daklinza (daclatasvir); Gilead’s Epclusa (sofosbuvir/velpatasvir); Gilead’s Harvoni (ledipasvir/sofosbuvir); Janssen’s Olysio (simeprevir); AbbVie’s Technivie (ombitasvir/paritaprevir/ritonavir); AbbVie’s Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets); AbbVie’s Viekira XR (dasabuvir/ombitasvir/paritaprevir/ritonavir); and Merck’s Zepatier (elbasvir/grazoprevir).