Lactic Acidosis/Severe Hepatomegaly; Acute Exacerbation of Hepatitis
Lactic Acidosis/Severe Hepatomegaly
- Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, in combination with other antiretrovirals
Acute Exacerbations of Hepatitis
- Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir.
- Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including tenofovir.
- If appropriate, resumption of anti-hepatitis B therapy may be warranted
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue tenofovir and are co-infected with HBV and HIV. If appropriate, initiation of anti-HBV therapy may be warranted.
- Obesity and prolonged nucleoside exposure may be risk factors for lactic acidosis and severe hepatomegaly. Therapy should be suspended in patients who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.
Patient Counseling Information