Abstract
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
Highlights
An estimated 257 million people globally are living with chronic hepatitis B (CHB) infection, according to the World Health Organization in 2018 [1]
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)
Nucleos(t)ide analogues (NAs) that have been approved for hepatitis B virus (HBV) treatment in humans include lamivudine (LAM), adefovir dipivoxil (ADV), entecavir (ETV), telbivudine (LdT), tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF), and can be classified into those associated with low barrier against HBV resistance (LAM, ADV, LdT) and those with high barrier to HBV resistance (ETV, TDF, TAF) [3,4,5]
Summary
An estimated 257 million people globally are living with chronic hepatitis B (CHB) infection, according to the World Health Organization in 2018 [1]. Treatment’s main goals in CHB are to halt disease progression and prevent disease-related complications, achieved by suppression of hepatitis B virus (HBV) DNA replication [2]. CHB treatment is either based on nucleos(t)ide analogue (NA) or on interferon IFNa, currently pegylated (PegIFNa) [3, 4]. The main advantage of treatment with a potent NA with high barrier to resistance (i.e., ETV, TDF, TAF), considered to be the first-line treatment for CHB, is its predictable high long-term antiviral efficacy leading to undetectable HBV DNA levels in the vast majority of compliant patients as well as its good safety profile [3,4,5]. It has been shown that NAs can improve the
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