Guidelines developed by other medical organizations including AASLD, EASL, and APASL were focused mainly on the prevention, care and treatment of hepatitis B for those living in higher income countries. The new WHO guidelines were developed with low-and-middle-income countries (LMICs) in mind, though they are certainly applicable in high-income countries as well.
These new WHO guidelines have it all: epidemiology and the global burden, virology, natural history of the virus, transmission, screening and prevention, diagnosis and treatment along with monitoring of both HBV infection and liver cancer. Although it may initially appear daunting, you’ll find the guidelines well organized, and thorough, with dark-blue boxed “Recommendations” and light-blue boxed “Rationales for Recommendations”. WHO recommendations even broach the topics of availability and cost.
The guidelines provide a framework for the development or strengthening of hepatitis B treatment programs. Target audiences include ministry of health policy makers in LMICs, non-governmental agencies and health care professionals organizing screening and treatment services, along with clinicians managing patients with chronic hepatitis B. They are also very helpful for those living with chronic hepatitis B interested in taking a more informed, active role in their care.
The WHO guidelines prioritize treatment for those with clinical evidence of compensated or decompensated cirrhosis. This determination is made based on the APRI (AST to platelet ratio index) score acquired through inexpensive, non-invasive means and include AST and platelet count blood tests. ALT levels, HBeAg status, HBV DNA levels (if available), age and other factors are also taken into account when determining who should or should not be considered for treatment. (Please note the following online calculator to determine the APRI ratio.) Details on the APRI ratio are on page 25 of the WHO guidelines.
When treatment is not recommended, regular monitoring is recommended along with lifestyle counseling including elimination or reduction of alcohol, smoking and substance abuse along with diet and physical activity. The hepatitis A vaccine is also recommended.
Here are more of the highlights:
Preventive measures continue to reinforce existing WHO recommendations including a birth dose of the HBV vaccine, preferably within 24 hours of birth, followed by 2 or 3 doses. Other preventive measures for HBeAg positive mothers are discussed including administering HBIG at birth, and the use of antiviral therapy during pregnancy. See page 87 of the WHO guidelines .
Treatment regimens include first-line antiviral therapies with tenofovir or entecavir. Antivirals such as lamivudine, adefovir, or telbivudine are not recommended since there is a low barrier to resistance. It is important to note that there is a long-term commitment to treatment with antivirals, and patients must be aware that it is dangerous to abruptly stop taking antivirals, and that they must be carefully monitored both on and off treatment. There are very specific rules for discontinuation of treatment that should be recommended to and adhered to by patients. Please refer to the guidelines (starting on page 47) for more details.
For purposes of these guidelines, treatment with immune modulators are not recommended because of the small percentage of responders, administration and monitoring of treatment (injectable requiring detailed followup), difficult side-effects, and contraindications as a result of other possible conditions.
Monitoring of hepatitis B on and off treatment is recommended at least annually, and include ALT, AST, platelet count, HBsAg, HBeAg and HBV DNA (where available or affordble). More frequent monitoring is recommended for those that do not meet the criteria for treatment, but have intermittent, abnormal ALT levels, HBV DNA levels fluctuating between 2,000 and 20,000 IU/mL, or are also HIV infected. More frequent monitoring is also recommended for those undergoing treatment or following treatment discontinuation. Please refer to the guidelines (page 69) for more details.
Routine surveillance for liver cancer (HCC) includes abdominal ultrasound and alpha-fetoprotein (AFP) testing and is recommended every 6 months for anyone with cirrhosis, a family history of HCC, and those over 40 yrs. of age without evidence of cirrhosis and a viral load greater than 2,000 IU/mL. Refer to page 81 of the WHO guidelines.
This ten thousand foot view of the WHO guidelines highlights topics of interest to those living with chronic HBV, and hopefully piques an interest, encouraging a more in-depth review of these evidence-packed, informative WHO guidelines. Check them out here!