WHO Issues First Hepatitis B Guidelines

The World Health Organization (WHO) recently released its first-ever guidelines for treatment of hepatitis B virus (HBV), which affects 240 million people worldwide and results in approximately 650,000 deaths per year, predominantly in low- and middle-income countries. The document, "WHO guidelines for the prevention, care and treatment of persons living with chronic hepatitis B infection," was published in March.

Medications can help people who have HBV live longer lives, but most people who need the medicines don’t have access to them or receive substandard care, in part due to lacking evidence-based guidance—especially in low- and middle-income countries.

“Deciding who needs treatment for hepatitis B depends on a number of factors,” Stefan Wiktor, MD, who leads WHO’s Global Hepatitis Program, said in a prepared statement. “These new guidelines, which give treatment recommendations that rely on simple, inexpensive tests, will help clinicians make the right decisions.”

Of note to laboratorians, for people who have cirrhosis at baseline, the guidelines recommend the use of simple, non-invasive tests to determine the stage of liver disease in order to decide who needs treatment, as well as routine monitoring that can provide early detection of liver cancer and determine whether treatment is working or if patients can stop treatment. The aspartate aminotransferase (AST)-to-platelet ratio index (APRI) should be used to look for cirrhosis (which has an APRI score >2 in adults) in countries with limited resources. Also, transient elastography, also known as FibroScan, is another non-invasive test that can be used to detect cirrhosis in locations where the test is available and in which cost does not bar it as an option.

Also, the following tests should be used to monitor people with HBV at least annually, according to WHO: alanine aminotransferase (ALT) level, AST (for APRI), hepatitis B surface antigen (HBsAg), Hepatitis B e antigen (HBeAg), and HBV DNA levels, where HBV DNA testing is available.

WHO recommends prioritizing treatment for people who have cirrhosis. Additionally, the guideline addresses special needs for children, adolescents, pregnant women, and people who are co-infected with HIV and HBV. The two medications recommended for treatment are tenofovir and entecavir, which are low risk for drug resistance, have few side effects, and can usually be purchased at low cost because they’re available as generics in most countries.

As a top priority, all adults and children with HBV and evidence of either compensated or decompensated cirrhosis should be treated, according to WHO. Treatment is also recommended for adults with HBV who don’t show evidence of cirrhosis (APRI score ≤2 in adults), but who are older than 30 and have persistently abnormal ALT levels, as well as evidence they have high-level HBV replication (HBV DNA >20 000 IU/mL), regardless of HBeAg status. The recommendations also make conditional recommendations for treatments of adults, children, and adolescents who do not fit this category, such as adults who have HBV but who do not show clinical evidence of cirrhosis.

To prevent new infections, WHO recommends that children get HBV vaccinations, starting with a dose given at birth. WHO also recently launched an injection safety policy to encourage the use of “smart” syringes, in order to keep syringes and needles from being re-used.