World Health Organization Issues First Hepatitis B Prevention and Treatment Guidelines

The World Health Organization (WHO) released its first-ever guidelines for the prevention, care, and treatment of hepatitis B virus (HBV) infection, a major cause of illness and death worldwide. For treatment, WHO recommends the antivirals tenofovir (Viread) or entecavir (Baraclude), and says that people with liver cirrhosis need treatment most urgently.

WHO estimates that approximately 240 million people worldwide have chronic hepatitis B, and the virus is endemic in much of Asia and Africa. Most people infected via mother-to-child transmission, and a minority of those infected as adults, are unable to clear the virus naturally and develop chronic infection.

Over years or decades chronic HBV infection can lead to serious liver disease including cirrhosis, hepatocellular carcinoma -- the second leading cause of cancer death -- and the need for a liver transplant. People who have already progressed to cirrhosis should be prioritized for treatment. The non-invasive APRI biomarker index or FibroScan transient elastography imaging are the recommended methods for assessing the extent of liver damage.

HBV infection can be prevented with a safe and highly effective vaccine. While current treatments usually do not cure hepatitis B, they can keep the virus under control long-term and reduce the risk of developing serious complications. The 2 recommended medications, tenofovir and entecavir, are taken as 1 pill once-daily, have a high barrier to resistance, are generally safe and well-tolerated, and are available as generics in many countries. Tenofovir is also active against HIV and is recommended, as part of combination antiretroviral therapy, for HIV/HBV coinfected people.

Below is an edited excerpt from a WHO press release summarizing the new guidelines. The full guidelines are available online.

WHO Issues its First Hepatitis B Treatment Guidelines

Geneva -- 12 March 2015 -- WHO today issued its first-ever guidance for the treatment of chronic hepatitis B, a viral infection which is spread through blood and body fluids, attacking the liver and resulting in an estimated 650,000 deaths each year -- most of them in low- and middle-income countries.

Worldwide, some 240 million people have chronic hepatitis B virus with the highest rates of infection in Africa and Asia. People with chronic hepatitis B infection are at increased risk of dying from cirrhosis and liver cancer.

Effective medicines exist that can prevent people developing these conditions so they live longer. But most people who need these medicines are unable to access them or can only obtain substandard treatment. One reason for this is the lack of clear evidence-based guidance for countries (especially low- and middle-income countries) as to who should be treated and what medicines to use.

"Deciding who needs treatment for hepatitis B depends on a number of factors," says Dr. Stefan Wiktor, who leads WHO's Global Hepatitis Program. "These new guidelines, which give treatment recommendations that rely on simple, inexpensive tests, will help clinicians make the right decisions."

The WHO guidelines for the prevention, care and treatment of persons living with chronic hepatitis B infection lay out a simplified approach to the care of people living with chronic hepatitis B, particularly in settings with limited resources.

The guidance covers the full spectrum of care from determining who needs treatment, to what medicines to use, and how to monitor people long-term.

Key recommendations include:

• the use of a few simple non-invasive tests to assess the stage of liver disease to help identify who needs treatment;
• prioritizing treatment for those with cirrhosis -- the most advanced stage of liver disease;
• the use of two safe and highly effective medicines, tenofovir or entecavir, for the treatment of chronic hepatitis B; and
• regular monitoring using simple tests for early detection of liver cancer, to assess whether treatment is working, and if treatment can be stopped.

The special needs of specific populations, such as people co-infected with HIV, as well as children and adolescents, and pregnant women are also considered.

The two recommended medicines are already available in many countries as generics, and thus are relatively inexpensive, costing as little as US$5 per person per month. "Because for so many people treatment is life-long it is important that patients can access these medicines at the lowest possible price," says Dr. Wiktor.

A number of countries are beginning to develop hepatitis B treatment programs, and the newly released document also provide guidance on how to organize hepatitis care and treatment services. "For example, countries need to think about ways to improve access to medicines and how best to deliver quality care that builds on existing health services and staff," says Dr. Philippa Easterbrook, from the WHO Global Hepatitis Program.

Treatment can prolong life for people already infected with hepatitis B, but it is also important to focus on preventing new infections. WHO recommends that all children are vaccinated against hepatitis B, with a first dose given at birth. Some countries, particularly in Asia, have reduced the rates of childhood hepatitis B infection through universal childhood vaccination. The challenge now is to scale up efforts to ensure that all children worldwide are protected from the virus.

Another route of infection is through the reuse of medical equipment, in particular of syringes. WHO has recently launched a new policy on injection safety that will also help prevent new hepatitis B infections. The policy calls for the worldwide use of “smart” syringes to prevent the re-use of syringes or needles.

The new guidelines on treating hepatitis B follow on from the publication last year by WHO of its first ever guidelines on treating hepatitis C.

3/16/15

Sources

World Health Organization. Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. March 2015.

World Health Organization. WHO Issues its First Hepatitis B Treatment Guidelines. Press release. March 12, 2015.