Chronic hepatitis B can be a severe, long-term disease
Progression of chronic hepatitis B
The course of chronic hepatitis B is nonlinear and characterized by repeated liver cell destruction and regeneration over long periods of time.1,2
Effects of chronic hepatitis B on the liver2,3
20% TO 30%
of adults with chronic hepatitis B will develop complications such as cirrhosis and potentially hepatocellular carcinoma4
For some patients, chronic hepatitis B is a lifelong disease that requires long-term or indefinite therapy.1,4-11
- People with chronic hepatitis B are at risk for developing comorbidities, including diabetes,
metabolic syndrome, and renal and bone conditions
- Risk for some comorbidities increases with age
Screening for chronic hepatitis B
Screening can help identify chronic hepatitis B early, so that necessary care, including antiviral therapy and/or surveillance for disease progression, may be considered.12
The USPSTF, CDC, and AASLD recommend screening the following patients5,13-16:
- People born in regions with prevalence of HBV infection ≥2%
- US-born people not vaccinated as infants whose parents were born in regions with prevalence of HBV infection ≥8%
- Household and sexual contacts of people with HBV infection
- All pregnant women
- Men who have sex with men
- Injection drug users
- People with certain medical conditions
- Needing immunosuppressive therapy
- Undergoing hemodialysis
- Infected with HCV or HIV
Chronic hepatitis B treatment goals
When a patient has been diagnosed with chronic hepatitis B, clinical endpoints of therapy include5,17:
- Achieving sustained suppression of HBV replication
- ALT normalization
- Reducing the risk of liver damage
- HBeAg and HBsAg loss with or without seroconversion
AASLD=American Association for the Study of Liver Diseases; ALT=alanine aminotransferase; CDC=Centers for Disease Control and Prevention; HBeAg=hepatitis B envelope antigen; HBsAg=hepatitis B surface antigen; HCV=hepatitis C virus; USPSTF=U.S. Preventive Services Task Force.
aHepatocellular carcinoma may occur in patients with chronic HBV without cirrhosis.4
IMPORTANT SAFETY INFORMATION
BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
- Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. 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 VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Warnings and Precautions
- Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
- New Onset or Worsening Renal Impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration.
- Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were headache, upper respiratory tract infection, abdominal pain, cough, back pain, arthralgia, fatigue, nausea, diarrhea, dyspepsia, and pyrexia.
- Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
- Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.
Dosage and Administration
- Testing Prior to Initiation: HIV infection.
- Prior to or When Initiating, and During Treatment: On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.
- Dosage in Adults: 1 tablet taken once daily with food.
- Renal Impairment: Not recommended in patients with end stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment.
- Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.
Please see full Prescribing Information for VEMLIDY, including BOXED WARNING.