The global burden of chronic hepatitis B remains high and the best possible treatment remains long-term viral suppression expecting cure.

Total 154 patients of chronic hepatitis B (48 HBeAg positive, e + ve) treated with oral entecavir (0.5 mg/1 mg per day) were recruited from June 2007 and followed prospectively until December 2022 for persistent HBV DNA negativity, HBeAg and HBsAg loss/seroconversion and other liver and drug-related events in real-life settings.

The mean duration of therapy was 6.78 (2-14) years with 1364 person-years of follow-up. All patients were HBV DNA negative by 15 months and remained so until the last follow-up. As many as 16.7% lost HBeAg after eight to 13 years of therapy, but not HBsAg. The mean fall in serum HBsAg level per year was 0.158 log IU/mL, being significantly higher in e + ve patients at baseline and until two years of therapy. The decline was significant until six years in e + ve patients compared to two years in e - ve ones. None had biochemical or virological breakthrough (except eight defaulters), flares or any untoward effects. The incidence of liver-related events, hepatocellular carcinoma and death was 10.4%, 1.9% and 14.3%, respectively, and 5.2% deaths were liver-related whose predictors were presence of cirrhosis (log rank 46.5, p > 0.001) and higher HBsAg level > 4 log IU/mL (log rank 18.15, p < 0.001) at baseline.

Long-term entecavir therapy provides additional benefits of continuous reduction of serum HBsAg levels beyond suppression of HBV DNA.

Emerging diseases are infectious diseases that pose significant threat to human health, causing millions of deaths and disabilities in the upcoming days. Periodic epidemics of new infections and old reinfections increase the global burden of disease prevalence. They can be caused by new pathogens or evolving ones, which change human behavior and environmental factors. Researchers have studied the dynamic connections between microbes, hosts, and the environment, but new infectious diseases like coronavirus disease 2019 (COVID-19), re-emerging diseases, and deliberately disseminated diseases persist despite earlier hopes of elimination. With heavy privatesector investments, Indian pharmacology now provides core Expanded Programme on Immunization vaccines to United Nations International Children's Emergency Fund, producing previously unattainable vaccines for diseases like meningitis, hepatitis B, pneumococcal conjugate, rotavirus, influenza A (H1N1), and COVID-19. India's vaccine sector has emerged, among the oriented leaders of the Bharat Biotech, Serum Institute of India, Panacea Biotech and Biological E. Specifically, the technology transferred from Western countries has benefited the sector, which produces 1.3 billion doses annually. The Serum Institute is the world's largest manufacturer of vaccines, providing measles and diphtheria-tetanus-pertussis vaccines to United Nations. The Serum Institute has developed several vaccines, including Nasovac, MenAfriVac, Pentavac, and an inactivated polio vaccine. India's success in vaccinations can be attributed to attractive investment conditions, government assistance, international alliances, and rising domestic technical talent. Despite its booming economy and technical advances, India's disproportionate share of the world's child mortality rate remains unchanged. However, the growing production and distribution of vaccinations in developing nations has initiated a new era, leading to a worldwide decline in childhood death and disease.

Asia has intermediate-to-high prevalence and high morbidity of hepatitis B virus (HBV) infection. The use of guideline-recommended nucleos(t)ide analogs with high barrier to resistance, such as entecavir (ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), is one of the key interventions for curbing HBV infection and associated morbidity in Asia. However, there are some challenges to the use of ETV and TDF; while ETV is associated with high resistance in lamivudine (LAM)-exposed (especially LAM-refractory) patients; bone and renal safety issues are a major concern with TDF. Hence, a panel of twenty-eight expert hepatologists from Asia convened, reviewed the literature, and developed the current expert opinion-based review article for the use of TAF in the resource-constrained settings in Asia. This article provides a comprehensive review of two large, phase 3, double-blind, randomized controlled trials of TAF versus TDF in HBeAg-negative (study 0108) and HBeAg-positive (study 0110) chronic HBV patients (> 70% Asians). These studies revealed as follows: (1) non-inferiority for the proportion of patients who had HBV DNA < 29 IU/mL; (2) significantly high rate of normalization of alanine aminotransferase levels; (3) no incidence of resistance; and (4) significantly better bone and renal safety, with TAF vs. TDF up to 144 weeks. Considering the benefits of TAF, the expert panel proposed recommendations for optimizing the use of TAF in Asia, along with guidance on specific patient groups at risk of renal or bone disease suitable for TAF therapy. The guidance provided in this article may help clinicians optimize the use of TAF in Asia.

To compare the efficacy of tenofovir and entecavir in nucleos(t)ide analogue-naive chronic hepatitis B.

The Web of Science, PubMed, Cochrane Library, EMBASE, Clinical Trials and China National Knowledge Infrastructure(CNKI) databases were electronically searched to collect randomized controlled trials (RCTs) regarding the comparison between tenofovir and entecavir in nucleos(t)ide analogue-naive chronic hepatitis B (CHB) since the date of database inception to July 2019. Two researchers independently screened and evaluated the obtained studies and extracted the outcome indexes. RevMan 5.3 software was used for the meta-analysis.

Early on, tenofovir had a greater ability to inhibit the hepatitis B virus, I2 = 0% [RR = 1.08, 95% CI (1.03, 1.13), P<0.01] (96 weeks). Entecavir can normalize the ALT levels earlier, I2 = 0% [RR = 0.87, 95% CI (0.77, 0.98), P = 0.02] (48 weeks). However, there was no statistically significant difference between TDF and ETV at 144 weeks. Tenofovir was as effective as entecavir in terms of HBeAg clearance and HBeAg seroconversion, I2 = 0% [RR = 1.05, 95% CI (0.68, 1.62), P = 0.82]; I2 = 69% [RR = 0.93, 95% CI (0.54, 1.61), P = 0.80]. The difference in the incidence of elevated creatine kinase levels was not statistically significant I2 = 0% [RR = 0.66, 95% CI (0.27, 1.60), P = 0.35].

Tenofovir and entecavir were equally effective in the treatment of patients with nucleos(t)ide analogue-naive chronic hepatitis B. In addition, TDF has an advantage in the incidence of hepatocellular carcinoma. Additional RCTs and a large-sample prospective cohort study should be performed.

Entecavir (ETV) is a nucleoside analogue (NA) that is effective for treatment of chronic hepatitis B (CHB) due to its low resistance rates and potent antiviral effects. We aimed to evaluate the clinical, biochemical and virological response to ETV in patients without a prior use of nucleos(t)ide (NA-naïve) vs. those who failed prior NA use (NA-experienced) in the treatment of CHB.

Patients treated between April 2012 and December 2017 were retrospectively studied. A comparison was made between patients treated with ETV in NA-naïve Vs. NA-experienced. Complete virological response (CVR) was defined as achieving undetectable HBV-DNA level, up to 15 IU/ml, partial virological response (PVR) as 15-200 IU/ml and >200 IU/ml for no virological response (NVR) after one year of therapy.

Overall, 148 patients were included (69 NA-naïve and 79 NA-experienced). In NA-naïve group, 51%, 17% and 32% achieved CVR, PVR and NVR vs. 17%, 9% and 75% in NA-experienced group, respectively (p < 0.001). HBsAg seroconversion was achieved in 5.8% in NA-naïve group vs. 6.3% in NA-experienced group (p = 1.00). HBeAg seroconversion was 17% in NA-naïve group and 25% in NA-experienced group (p = 0.24). There was no significant difference in alanine transaminase normalization or in mortality rate between both groups; p = 0.87 and p = 1.00 respectively.

ETV therapy in CHB results in a better virological response in NA-naïve patients compared to NA-experienced. There were no differences between both groups in regards to the rate of HBsAg or HBeAg seroconversions, biochemical improvements or mortality.

Hepatitis B is a significant public health problem in India, yet disease awareness is very low among the general population. The disease is mostly acquired horizontally, but the role of vertical transmission should not be underestimated. In spite of the fact that the majority of cases are e negative disease, most patients present in the advanced stage and even with hepatocellular carcinoma, the leading cause of which is hepatitis B. High-risk groups (especially tribals) also harbour significant disease burden and have a high prevalence of occult infection, supporting the potential of unknowingly spreading the disease. Findings on the relation of genotypes with disease severity or drug action have been conflicting. Though recently, oral antivirals with high genetic barrier to resistance have shown good viral suppression in the long term, e and s seroconversion is poor and relapse is universal upon therapy discontinuation. As no cure is possible with the currently available therapy, the target is long-term viral suppression by prolonged administration of oral antivirals; unfortunately, this leads to poor treatment adherence, which along with the high cost of therapy results in disease progression and spread of infection. At present, therefore, emphasis should be put on health education of the general and high-risk populations, along with health care workers to increase knowledge on such preventive measures as avoiding unsafe injection practices, high-risk sex, performing unnecessary injection and blood transfusion and providing proper screening of blood products; these efforts should be combined with intensive screening and aggressive vaccination programs, especially in high-risk groups and areas of high endemicity. Vaccination strategies are still below par and logistics should be developed for wider coverage; in addition, further research should be carried out on the efficacy and mode of usage for different types of vaccine.