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• W3206806735 abstract "Content available: Audio Recording About 257 million persons are infected with chronic hepatitis B (CHB) globally, resulting in 887,000 deaths annually. More than 90% of the deaths and disability as a result of viral hepatitis can be attributed to CHB and chronic hepatitis C infections.1 The World Health Organization (WHO) approved the strategy to eliminate viral hepatitis as a public health threat by 2030, which requires that new CHB be reduced by 90% and mortality attributable to CHB be reduced by 65%.2 India falls in the intermediate hepatitis B virus (HBV) endemicity group, with a prevalence rate of 2% to 4% in the general population. Transmission is believed to mostly occur horizontally during early childhood by close physical contact, although up to 30% of cases are due to vertical transmission. India harbors 10% to 15% of the global pool of HBV and has 40 million HBV carriers, of whom 15% to 25% develop cirrhosis and complications leading to health care costs and premature death. Of the 26 million infants born each year, 1 million run the lifetime risk for HBV infection.3 There is population heterogeneity with the point prevalence of HBV in India estimated to be 2.4% (95% confidence interval [CI]: 2.2%-2.7%) and in tribal areas as high as 15.9% (95% CI: 11.4%-20.4%). Clusters of HBV infection are noted in regions like Ladakh (12.7%), Arunachal Pradesh (21.2%), and the Nicobarese (23.3%), Shompen (37.8%), and Jarawa (65%) tribes of the Andaman and Nicobar Islands.4 Another cause for spread is unsafe injections with reuse of syringes or needles. About 16 billion injections are prescribed annually worldwide, and more than half are unsafe. India contributes to 25% to 30% of the global load, with a frequency of 2.9 injections per person. Causality can be attributed to unsafe injections in 46%, 38%, and 12% of cases in HBV, hepatitis C virus (HCV), and HIV transmission.5 Hepatitis B surface antigen (HBsAg) positivity plateaus at 2% to 3% by 5 years of age and remains constant thereafter, whereas anti-HBsAg positivity continues to increase with age, suggesting that most chronic infections occur by 5 years of age, and exposure at older age usually results in clearance of virus with development of protective antibodies. The prevalence of HBV seropositivity in dialysis patients is 5% to 13%, with reuse of dialyzers and multidose vials of heparin or injectable iron being events for transmission. In the case of HBV, to ensure 90% reduction in new chronic infections and 65% reduction in mortality, we require 90% infant vaccination, 80% neonatal vaccination, peripartum antivirals to 80% hepatitis B e antigen (HBeAg)-positive mothers, and 80% coverage in population-wide testing and treatment. All these interventions will avert 7.3 million deaths between 2015 and 2030, including 1.5 million deaths attributable to cancer globally6 (Fig. 1). India launched the National Viral Hepatitis Control Programme (NVHCP) on July 28, 2018, to provide free-of-charge, algorithm-based treatment of chronic viral hepatitis C and B using a decentralized hub-and-spoke model.7 A major milestone was adoption of immunization for HBV in the national immunization program since 2011 to 2012. At the community level, vaccination of other high-risk individuals, such as persons with HIV-AIDS, dialysis, and blood transfusion recipients, regular or family contacts of someone who is HBV infected, persons who inject drugs (PWIDs), among others, is essential.8 Expansion of immunization to persons with diabetes and chronic kidney disease, among others, should be considered. Mother-to-child transmission (MTCT) accounts for 30% to 50% of new infections in south Asian countries. Vertical transmission can be prevented by providing tenofovir disoproxil fumarate (TDF) to HBeAg-positive mothers with HBV DNA >106 IU/mL from 32 weeks onward until 3 months after delivery. Infants of such mothers are advocated to receive birth dose vaccination, and in some high-risk cases hepatitis B immunoglobulin (HBIG). Timely delivery of the birth dose of HBV vaccine within 6 hours of birth or at least within 24 hours is a low-cost, safe, evidence-based intervention. In women with high viral load, timely birth dose vaccination can prevent MTCT even in the absence of HBIG. In women who are HBeAg negative with low HBV DNA and lack prior perinatal transmission, a birth dose vaccination suffices.9 Harm reduction measures include injection safety programs, better blood banking protocols, and biomedical waste management (Fig. 2). To target high-risk individuals such as PWIDs, deaddiction programs that are locally available, socially and culturally acceptable, and incorporate integrated care for opioid substitution, needle exchange, and HBV treatment linkage are required. Screening of blood products is mandatory in India since 1992, with many centers now adopting nucleic acid testing of blood. The use of transient elastography has enabled noninvasive diagnosis of fibrosis where histopathological diagnosis is not available. Use of low-cost tools, such as aspartate aminotransferase-to-platelet ratio and Fibrosis-4, has simplified the treatment algorithms for fibrosis estimation under the NVHCP.10 The availability of generic, efficacious antiviral drugs for both HBV and HCV in India is another advantage. Our pharmaceutical industry has also provided WHO-approved nucleot(s)ide analogues (NAs) to other Asian countries, Africa, and “Buyers’ Clubs” in the United States and Europe. The cost of generic TDF and ETV is less than US $8.5 a month when purchased at market prices in India and is reduced further if large-scale, centralized procurement is done under the NVHCP.11 Because the main thrust of the NVHCP is on immunization, it is disheartening to note that in 2015 to 2016, 45% of the children aged 12 to 59 months were not vaccinated for HBV as per data of 199,899 children in the National Family Health Survey-4. A child’s HBV immunization is guided by the family’s socioeconomic status, maternal education, birth order, and region of origin.12 Aggarwal et al.13 found that birth cohort immunization can reduce the population prevalence rate from 4.0% to 1.15%, but this still leaves a large gap in clearing the reservoir. A modeling study for 120 countries showed only 29 million (10%) infections have been diagnosed, 4.8 million (5%) of eligible people have ever received NA therapy, and less than 1% of eligible pregnant women received antivirals to prevent MTCT. Of the 87% of infants who are estimated to have received vaccination, only 46% received the birth dose vaccine. The study suggests that scaling up vaccination to 90% globally will avert 4.3 million new infections, and the addition of peripartum NA therapy and birth dose vaccination will avert a further 19.3 million deaths, mostly because of the latter intervention. However, the timelines for elimination will be around 2060 to 2080 by these interventions in Asian countries.6 A major pitfall in our approach to HBV elimination is the lack of public and health care personnel awareness regarding the diagnosis and management of CHB. Availability of immunization, safe injection practice, blood banking safety protocols, biomedical waste management, need for correct drug prescriptions, and compliance with follow-up in CHB for disease progression and hepatocellular carcinoma (HCC) surveillance are essential. The high prevalence rate of the virus in India suggests that there is a huge reservoir of infection, which is continuously spreading the virus and resulting in new HBV infections (Fig. 3). As per Current Practice Guidelines (CPGs) of the European Association for the Study of the Liver, Asian Pacific Association for the Study of the Liver, and American Association for the Study of Liver Diseases, individuals aged >30 to 40 years with immune active (IA) chronic hepatitis evidenced by raised alanine aminotransferase (ALT), increased fibrosis (by noninvasive elastography), necroinflammation on biopsy, or presence of cirrhosis and decompensation are treated.14 The window of opportunity for treatment is short, and all patients require a strict 3- to 6-month follow-up, with surveillance for HCC, regardless of drug therapy. Unless we expand access to care, we will fail to meet the elimination milestones set by the WHO not just in India but globally. Provisions exist for treating immune-tolerant (IT) individuals in CPGs like medical personnel, pregnant women for preventing MTCT, immunosuppressed or chemotherapy recipients, and first-degree IT relatives of persons with HBV-related HCC. However, PWIDs, dialysis recipients, military personnel, and care home residents are still not offered therapy despite having similar risks for transmission (Fig. 3). Recent data from the population cohorts from Taiwan and Korean suggest that long-term complications like HCC are related to HBV DNA level and age rather than to ALT. The REVEAL HBV study15 had a median follow-up of 10.7 years and found the association between HBV DNA and HCC was independent of smoking, alcohol, HBeAg status, cirrhosis, or ALT level. Kim et al.16 showed that a cumulative incidence of HCC was 12.7% versus 6.1% (P = 0.001), and death or transplantation was 9.7% versus 3.4% (P < 0.001) in IT versus IA groups, respectively. The ALT level does not correlate reliably with liver necroinflammation or HBV genome integration into hepatocyte DNA. Other lacunae are lack of estimation of covalently closed circular DNA (cccDNA) and viral rebound on therapy in precore mutants.15, 16 The use of hepatitis B core-related antigen (HBcrAg) and HBV RNA levels is probably a better surrogate for cccDNA, rather than quantitative (q) HBsAg levels. Lastly, lack of correct histological diagnosis of necroinflammation, because of unwillingness to perform a biopsy, is a great pitfall in our current approach to CHB. Another factor impacting the pathogenesis of HBV-related liver disease is the epidemic of nonalcoholic fatty liver disease. Some animal models suggest that steatosis reduces HBV replication by inhibiting cccDNA, changing the microbiota, and inversing the HBV DNA and histological steatosis and triglyceride relationship, while others suggest a synergistic effect with HBV DNA, culminating in accelerated carcinogenesis. Although HBV vaccination can reduce new infections, we are yet to find a cure for HBV, and hence patients need to be on long-term or even lifelong treatment to achieve viral suppression. The drug resistance to TDF is practically nonexistent because four mutations need to accumulate to prevent drug action.17 Clinicians should understand that “drug resistance” is not caused by antiviral treatment and is caused by a selection of strains with preexisting genomic resistance because of the use of effective drugs. If the individual does not infect others with HBV, the “resistance” cannot spread. Even if therapy is given lifelong, it is cost-effective in Asian countries because it offsets the direct health care costs of managing late complications, such as decompensation, HCC, admissions, and transplantation, and the indirect costs of low economic productivity and wage losses because of CHB.18 The use of machine learning to assess the vast amount of data collected in the NVHCP will provide new information to make decision trees, especially in a bid to correctly diagnose degree of fibrosis, preemptively treat for complications of CHB and HCC, and predict transplant-free survival. The success of the current practice of managing HBV in India can also be indirectly gleaned from liver transplant and hospital databases. Currently, alcohol (34.3%) is the most common cause of cirrhosis, but HBV remains the most common cause of chronic liver disease (40.8%) and HCC (46.8%). It is also time to create a population registry for hepatitis B under the NVHCP. This will generate more information regarding hyperendemic pockets, help improve immunization coverage, provide real-world data regarding incidence of liver-related complications, plan community-based interventions, and yield epidemiological information on the lines of the Taiwan and Korean cohorts. It is time that we correct the course of evidence-based practice by improving immunization coverage and expanding access to care in CHB. The appropriate population screening and treatment strategies need to be adopted in a decentralized fashion under the national program for viral hepatitis elimination. The choice of monitoring tests, the central role of liver histology, use of noninvasive tests, diagnosis of cccDNA, and integration of HBV genome using HBcrAg and HBV RNA also require evaluation. Creation of a national viral hepatitis and transplant registry will improve the poor epidemiological data that impair formulation of appropriate health care policies. India’s emergence as a hub for affordable transplantation offers hope for management of advanced disease and curative therapy for HCC." @default.
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• W3206806735 title "Chronic Hepatitis B: Challenges and Successes in India" @default.
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