HBsAg clearance in chronic hepatitis B patients with add-on pegylated interferon alfa-2a to ongoing tenofovir treatment: A randomized controlled study

Background: Surface antigen (HBsAg) seroclearance in chronic hepatitis B (CHB)is associated with improved outcomes and permits safe treatment discontinuation. Current treatments (nucleos(t)ide analogues [NA], pegylated interferon [pegIFN])have low HBsAg seroclearance rates. New therapies aim to improve these rates.Aim: To use historical data to quantify the mean change from baseline in HBsAg at week 24 and the seroclearance rate at week 48 under standard-of-care treatment. Methods:We searched PubMed, ClinicalTrials.gov, and conference presentations for CHB studies with NAs (tenofovir, entecavir) or pegIFN. HBsAg decline and seroclearance were evaluated by a random effects meta-analysis. Treatment type, HBsAg baseline values, and hepatitis B virus (HBV) genotype, recruitment region were explored as heterogeneity sources. Results:One hundred and fifty-eight cohorts (over 10 000 patients; 71 studies [randomised controlled; prospective cohorts; retrospective cohorts]) were analysed. With NAs, 24-week HBsAg decline was minimal for treatment-naïve HBeAgnegative, and virologically suppressed patients. Considerable heterogeneity was observed in NA-treated HBeAg-positive patients, impacted by HBV genotype, NA type and HBsAg baseline levels. 48-week HBsAg seroclearance rates were low in all NA-treated groups (<1%/group). HBsAg declines and seroclearance rates were greater with pegIFN (also greater intra-subject variation within studies) vs NAs. Conclusions:This meta-analysis demonstrates good consistency between studies and limited within-study variation for the endpoint of HBsAg seroclearance at week 48 on NA treatment. For novel agents, these results can be applied to quantify control arm performance in study designs with historical borrowing. | 107 SLAETS ET AL.

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Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

Fraga

Vaisberg

Mendes

et al. 2020

J Gastroenterol

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Nucleos(t)ide analogues (NAs) are the main drug category used in chronic hepatitis B (CHB) treatment. Despite the fact that NAs have a favourable safety profile, undesired adverse events (AEs) may occur during the treatment of CHB. Given the eminent number of patients currently receiving NAs, even a small risk of any of these toxicities can represent a major medical issue. The main objective of this review was to analyse information available on AEs associated with the use of NAs in published studies. We choose the following MesH terms for this systematic review: chronic hepatitis B, side effects and treatment. All articles published from 1 January 1990 up to 19 February 2018 in MEDLINE of PubMed, EMBASE, the Cochrane Library and LILACS databases were searched. A total of 120 articles were selected for analysis, comprising 6419 patients treated with lamivudine (LAM), 5947 with entecavir (ETV), 3566 with tenofovir disoproxil fumarate (TDF), 3096 with telbivudine (LdT), 1178 with adefovir dipivoxil (ADV) and 876 with tenofovir alafenamide (TAF). The most common AEs in all NAs assessed were abdominal pain/discomfort, nasopharyngitis/upper respiratory tract infections, fatigue, and headache. TAF displays the highest density of AEs per patient treated among NAs (1.14 AE/treated patient). In conclusion, treatment of CHB with NAs is safe, with a low incidence of AEs. Despite the general understanding TAF being safer than TDF, the number of patients treated with TAF still is too small in comparison to other NAs to consolidate an accurate safety profile. PROSPERO Registration No. CRD42018086471

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HBsAg clearance in chronic hepatitis B patients with add-on pegylated interferon alfa-2a to ongoing tenofovir treatment: A randomized controlled study

Cited by 12 publications

References 29 publications

Combination treatment of pegylated interferon and tenofovir versus tenofovir for people with chronic hepatitis B

Combination treatment of pegylated interferon and tenofovir versus tenofovir for people with chronic hepatitis B

Systematic review with meta‐analysis: hepatitis B surface antigen decline and seroclearance in chronic hepatitis B patients on nucleos(t)ide analogues or pegylated interferon therapy

Adverse events of nucleos(t)ide analogues for chronic hepatitis B: a systematic review

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