On February 14, 2017 FDA approved class labeling revisions regarding the risk of hepatitis B virus reactivation in patients coinfected with hepatitis C virus (HCV) and hepatitis B virus (HBV). The class labeling applies to the following HCV direct acting antiviral (DAA) agents:
- Daklinza (daclatasvir)
- Epclusa (sofosbuvir/velpatasvir)
- Harvoni (ledipasvir/sofosbuvir)
- Olysio (simeprevir)
- Sovaldi (sofosbuvir)
- Technivie (ombitasvir/paritaprevir/
ritonavir) - Viekira Pak (ombitasvir/paritaprevir/
ritonavir tablets; dasabuvir tablets) - Viekira XR (dasabuvir/ombitasvir/
paritaprevir/ritonavir) - Zepatier (elbasvir/grazoprevir).
The key messages from the class labeling revisions include:
- Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating treatment with HCV 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.
- Initiate appropriate patient management for HBV infection as clinically indicated.
Below is the new class labeling information included for the HCV DAAs labels. Note [Drug X] applies to each of the HCV DAAs listed above.
FULL PRESCRIBING INFORMATION
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to the Initiation of Therapy
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with [DRUG X] [see Warnings and Precautions (5.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals, and who were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive and also in patients with serologic evidence of resolved HBV infection (i.e., HBsAg negative and anti-HBc positive). HBV reactivation has also been reported in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV direct-acting antivirals may be increased in these patients.
HBV reactivation is characterized as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA level. In patients with resolved HBV infection, reappearance of HBsAg can occur. Reactivation of HBV replication may be accompanied by hepatitis, i.e., increases in aminotransferase levels and, in severe cases, increases in bilirubin levels, liver failure, and death can occur.
Test all patients for evidence of current or prior HBV infection by measuring HBsAg and anti-HBc before initiating HCV treatment with [DRUG X]. In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during HCV treatment with [DRUG X] and during post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
17 PATIENT COUNSELING INFORMATION
Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV
Inform patients that HBV reactivation can occur in patients coinfected with HBV during or after treatment of HCV infection. Advise patients to tell their healthcare provider if they have a history of HBV infection [see Warnings and Precautions (5.1)].
Patient Information
What is the most important information I should know about [DRUG X]?
[DRUG X] can cause serious side effects, including,
Hepatitis B virus reactivation: Before starting treatment with [DRUG X], your healthcare provider will do blood tests to check for hepatitis B virus infection. If you have ever had hepatitis B virus infection, the hepatitis B virus could become active again during or after treatment of hepatitis C virus with [DRUG X]. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure and death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop taking [DRUG X].
Before taking [DRUG X], tell your healthcare provider about all of your medical conditions, including if you:
- have ever had hepatitis B virus infection
What are the possible side effects of [DRUG X]?
[DRUG X] can cause serious side effects, including:
- Hepatitis B virus reactivation. See “What is the most important information I should know about [DRUG X]?”
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
Office of Health and Constituent Affairs
Food and Drug Administration
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Division of Antiviral Products
Food and Drug Administration
For more information about the Hepatitis Liaison Program visit the FDA Patient Network
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