Decisions on treating chronic hepatitis B virus (HBV) infection in patients without cirrhosis should be based on HBV DNA and alanine aminotransferase (ALT) levels, according to updated guidance.
Seven expert panelists reviewed the available evidence and used clinical experience and consensus opinion to update an existing treatment algorithm on managing chronic HBV infection in the United States. The guidance was last updated in 2015. The revised version was published by Clinical Gastroenterology and Hepatology on July 27.
In the absence of cirrhosis, no treatment is recommended for patients with HBV DNA levels below 2,000 IU/mL and normal ALT levels, the algorithm noted. It recommended assessing ALT levels every six to 12 months and, if levels increase, checking serum HBV DNA levels and excluding other causes of disease. Therapy should be considered if significant histologic disease is present, the algorithm said.
In patients with no cirrhosis and with normal ALT levels but HBV DNA levels of 2,000 IU/mL or greater, decisions about treatment should be based on hepatitis B e antigen (HbeAg) status, according to the algorithm. Patients without cirrhosis but with elevated HBV DNA and ALT levels should be treated with entecavir, tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), or peginterferon alfa-2a. The algorithm noted that long-term treatment may be necessary if oral agents are used.
Patients with cirrhosis should be treated according to type (i.e., compensated or decompensated), the algorithm said. Those in the former group should receive entecavir, 0.5 mg; TAF, 25 mg; or TDF, 300 mg. Those with well-compensated cirrhosis can be treated with peginterferon alfa. For those in the latter group, entecavir, 1 mg, or TDF, 300 mg, is preferred, and TAF is not recommended.
All patients with HIV and HBV co-infection should be treated, the algorithm noted. Single-therapy HBV agents should be avoided, and long-term treatment is required. Patients should be assessed for fibrosis and hepatocellular carcinoma before treatment begins. Endoscopy should be performed in those with platelet counts below 120,000/μL or severe fibrosis to detect any varices. TDF or TAF plus emtricitabine or lamivudine is preferred in patients with HBV and HIV co-infection who are naive to HBV treatment; entecavir plus highly active antiretroviral therapy is also an option in this group. For patients with co-infection whose HBV is resistant to lamivudine, the preferred therapies are emtricitabine, 200 mg, and tenofovir disoproxil fumarate, 300 mg, or tenofovir plus entecavir, the algorithm noted.
The algorithm also offers advice on treatment duration, renal toxicity, and virologic resistance, among other topics. The expert panelists indicated that the updated algorithm is intended to serve as a guide to manage chronic HBV infection while new antiviral strategies are being developed. “Although a variety of agents are in clinical development, for the next few years the panel anticipates that currently licensed agents will continue to be the only options available to treat HBV infection,” they wrote. “The panel feels that efforts to identify HBV infected patients as well as continuing to reevaluate the need for antiviral therapy in each patient are important goals.”