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Lost in Translation: HBV Management Amid the ‘Jungle of Guidelines’
To most non-hepatologists like myself and many of you reading this, the treatment of hepatitis B is, quite frankly, a mess.
Currently, the guidelines available to us are from the AASLD and published in 2015; the other associations to whom a non-hepatologist might turn for guidance refer to these. In the available guidance, the delineation of those who are eligible for treatment vs. those who can be observed requires a deep dive into a long list of lab test results, including surface antigen, e antigen, surface antibody, e antibody and HBV DNA. These levels require a lot of categorization to be certain if treatment is indicated or not, mostly owing to the complexity of chronic HBV disease states. The guidelines on who to treat and for how long are very confusing, but for certain key populations, we know reducing the burden of hepatitis B replication is valuable to the patient in terms of stabilizing their liver progression. So where does that leave us?
There are ways to bring HBV under control and the development of more direct-acting agents such as Baraclude (entecavir, Bristol-Myers Squibb) or tenofovir-based products, as opposed to the use of interferon, makes using medications to control HBV replication much more approachable. However, when to implement these therapies and for how long remain cloudy to most clinicians who are not engaged in hepatitis care every day. And, unfortunately, the development of approaches to a “cure” is further down the road.
The focus on cure research and hepatitis B is still quite exciting. Many new drugs and targets are in development in a fashion reminiscent of the hepatitis C revolution that emerged more than a decade ago. We can hope the progress in hepatitis B eradication and cure will be just as efficient and timely as hepatitis C, although the biology of this virus seems not quite as yielding to a cure as hepatitis C turned out to be.
In the meantime, clinicians who would like to initiate entecavir or tenofovir are left with excursions into the jungle of the treatment guidelines that are mostly qualified with statements related to particular levels of antigenemia or HBV DNA or transaminase levels that reflect the complexities of chronic HBV disease categorization.
To the credit of those who wrote the HBV guidelines, these are data-driven guidelines. Unfortunately, there are many missing data. Instead of filling in those gaps with suggestions based on expert opinion regarding what to do in the face of missing data, clinicians are left without direction. This is especially true regarding duration of therapy with DAA products (entecavir and tenofovir), which according to most experts, is continued indefinitely once initiated.
Hopefully, AASLD and IDSA can get together like they did for the HCV guidelines and produce a living document online that is clear, concise and directive for people in practice. Indeed, the production of such guidelines along with perhaps an algorithm that can be readily used in practice would be welcomed by all.
Disclosure: Saag reports receiving research support and acting as a scientific advisor to Bristol-Myers Squibb, Gilead, Merck and ViiV.