Asian-Pacific Association for the Study of the Liver (APASL) consensus guidelines on invasive and non-invasive assessment of hepatic fibrosis: a 2016 update.

Hepatic fibrosis is a common pathway leading to liver cirrhosis, which is the end result of any injury to the liver. Accurate assessment of the degree of fibrosis is important clinically, especially when treatments aimed at reversing fibrosis are being evolved. Despite the fact that liver biopsy (LB) has been considered the "gold standard" of assessment of hepatic fibrosis, LB is not favored by patients or physicians owing to its invasiveness, limitations, sampling errors, etc. Therefore, many alternative approaches to assess liver fibrosis are gaining more popularity and have assumed great importance, and many data on such approaches are being generated. The Asian Pacific Association for the Study of the Liver (APASL) set up a working party on liver fibrosis in 2007, with a mandate to develop consensus guidelines on various aspects of liver fibrosis relevant to disease patterns and clinical practice in the Asia-Pacific region. The first consensus guidelines of the APASL recommendations on hepatic fibrosis were published in 2009. Due to advances in the field, we present herein the APASL 2016 updated version on invasive and non-invasive assessment of hepatic fibrosis. The process for the development of these consensus guidelines involved review of all available published literature by a core group of experts who subsequently proposed consensus statements followed by discussion of the contentious issues and unanimous approval of the consensus statements. The Oxford System of the evidence-based approach was adopted for developing the consensus statements using the level of evidence from one (highest) to five (lowest) and grade of recommendation from A (strongest) to D (weakest). The topics covered in the guidelines include invasive methods (LB and hepatic venous pressure gradient measurements), blood tests, conventional radiological methods, elastography techniques and cost-effectiveness of hepatic fibrosis assessment methods, in addition to fibrosis assessment in special and rare situations.

Reimbursement policies in the Asia-Pacific for chronic hepatitis B.

BACKGROUND: There is considerable variation in reimbursement policies in Asian countries and this is likely to have an impact on treatment practice for chronic hepatitis B (CHB). Consequently a survey of leading hepatologists was performed to evaluate such policies and their impact on management of CHB in the Asia Pacific region. METHODS: A questionnaire was sent to key hepatologists in Asia Pacific for information on CHB reimbursement policy-its nature, coverage, funding source, duration, review strategy and impact on Asia Pacific Association for the Study of the Liver (APASL) CHB guidelines. The results were analysed and described. RESULTS: Leading hepatologists from 16 Asia Pacific countries responded. Almost all of the countries have reimbursement policies but eligibility varied from only a limited group (e.g. civil servants only) to universal access. In most instances reimbursement was from the central government (except China, Pakistan and Hong Kong). Reimbursement policies were usually created by Ministry of Health committees, who received input from medical professionals, although they may not be aware of the APASL guidelines. Policies were limited by available resources, funds and prioritization. Where there was a regular review this occurred between 1 and 5 years. The quantum of reimbursement varied from 50% in Singapore to 100% in the majority of other countries. The criteria for treatment reimbursement were based on doctor's opinion alone (Bangladesh, India, Pakistan, Philippines, Singapore and Vietnam) or specific clinical/laboratory criteria in the rest of the countries. In general, most countries offered unlimited duration for reimbursement except Taiwan, Indonesia and Pakistan. Monitoring tests for treatment response were reimbursed in all countries other than Vietnam. Viral resistance was diagnosed by viral or biochemical breakthrough, and viral resistance testing was uncommon. The main rescue therapy was adefovir. CONCLUSION: Reimbursement policies differed from country to country, the quantum and the proportion of patients who received reimbursement also varied significantly. Asia Pacific countries were able to follow APASL guidelines with variable success based on their reimbursement policies.

Influence of the sorafenib patients assistance program on treatment compliance and overall survival of unresectable hepatocellular carcinoma patients.

AIM: to evaluate treatment compliance and survival of patients receiving oral sorafenib in Indonesia. METHODS: a prospective cohort trial. Unresectable Hepatocelullar carcinoma patients receiving Sorafenib in NexPAP program were recruited between October 2008 and September 2011. A historical cohort from Cipto Mangunkusumo Hospital, between 1998 and 2000 was selected to serve as control group. Patients in the control group received symptomatic treatment. Survival analysis was done by the Kaplan-Meier survival curve analysis and the log-rank test. Median survival difference between the NexPAP and control group was tested using the Cox-regression hazard analysis. RESULTS: There were 48 patients in the NexPAP group and 40 patients in the control group. Treatment compliance was very good; no patient with drew from the study. Sorafenib generally could be tolerated by the patients. The most common adverse events are mild or moderate hand and foot skin reaction and diarrhea. The median survival was 49 weeks in NexPAP group (95% CI 37.9-60.1) vs. 20 weeks in the control group (95% CI 9.0-31.0). Cox-regression analysis showed that sorafenib significantly prolonged overall survival with a hazard ratio (HR) of 0.339 (95% CI: 0.196-0.584). There was no survival difference between patients with Child-Pugh class A and class B in both NexPAP (median 49 vs. 52 weeks; HR 1.1; 95% CI 0.5-2.3; p=0.855) and control groups (27 vs. 20 weeks; HR 1.1; 95% CI 0.5-2.4; p=0.822). CONCLUSION: Sorafenib patient assistant program in unresectable hepatocellular carcinoma ensured compliance treatment and significantly prolonged overall survival over the historical cohort receiving palliative treatment.