Combating hepatitis through multipronged approach

Recognizing Hepatitis as a public health threat, India is committed to tackle it with urgency through prevention, management, diagnosis and treatment, monitoring and evaluation, and training and capacity building. Ministry of Health and Family Welfare (MoHFW) has published the National Viral Hepatitis Control Program operational guidelines (NVHCP), with the goal of ending viral hepatitis as a public health threat by 2030 in the country and will work in coordination with Ministry of Environment & Forests (MoEF), Ministry of Housing and Urban Affairs (MoHUA) and Department of Water Resources, RD & GR, Ministry of Jal Shakti to tackle the hepatitis infection among common masses. The 69th World Health Assembly which endorsed the global projected, Hepatitis C virus (HCV) elimination strategy by 203 0, which is possible due to integrative use of all oral, cost-effective, efficacious, and generic direct-acting antivirals (GDAA’s).

The viral hepatitis is the main concern for health care sector in India and it is equated HIV/AIDS, malaria and tuberculosis, the “big three” communicable diseases threats. Health care experts believe that reduction in the global burden of hepatitis depends upon success of prevention interventions, implementation of outreach screening, and progress made in key high-burden countries including China, India, Pakistan and Egypt.

Research studies have shown that Hepatitis E virus are predominantly enterically transmitted pathogens and are responsible epidemics of acute viral hepatitis, while as Hepatitis B- and Hepatitis C virus predominantly spread through parenteral route and cause liver cirrhosis and hepatocellular carcinoma. Owing to the fact that 9 out of 10 people living with viral hepatitis are unaware, this year’s theme of world hepatitis day, observed on 28 July 2019, is “Find the Missing Millions” to tackle the main barriers to diagnosis.

            Nevertheless, India is also committed to achieving Sustainable Development Goal (SDG) 3.3 which aims to combat viral hepatitis. The Government of India is a signatory to the resolution 69.22, endorsing WHO Global Health Sector Strategy on Viral Hepatitis 2016-2021 at 69th WHA towards ending viral hepatitis by 2030. At 69th WHA, it was discussed that the public health strategy targets not only diagnosed chronic hepatitis C patients but also asymptomatic undiagnosed HCV-infected individuals, persons living with HIV, post-transplant, thallasemia, persons who inject drugs, and the pediatric population. Mobilization of state-sponsored HCV elimination programs in a global coalition against HCV has taken root in India among other few countries.

            MoHFW has published the National Viral Hepatitis Control Program operational guidelines (NVHCP), with the goal of ending viral hepatitis as a public health threat by 2030 in the country. The aim of NVHCP is to combat hepatitis and achieve country wide elimination of Hepatitis C by 2030. It further includes achievement of significant reduction in the infected population, morbidity and mortality associated with Hepatitis B and C viz. cirrhosis and hepato-cellular carcinoma and reduction of risk, morbidity and mortality due to Hepatitis A and E. However, the key components of the initiative are preventive component management, diagnosis and treatment, monitoring and evaluation, and training and capacity building.

Some of the major efforts undertaken in India to tackle Hepatitis infections include:

Immunization with Hepatitis B vaccine: The national immunization agenda advocates hepatitis B birth dose to all infants in first 24 hours, followed by three primary series at 6, 10 and 14 weeks.

Safety of Blood and blood products: Availability of safe blood is one of the most important measures to prevent viral hepatitis by Hepatitis B virus (HBV) and HCV. Blood Banks are regulated by an Act of parliament namely “The Drugs and Cosmetics Act, 1940” and in all licensed Blood Banks, screening for Hepatitis C has been made mandatory across India.

Harm reduction in key populations: India has always focused on preventive measures, however, under National AIDS Control Program; targeted interventions were made among bridge populations such as migrants and truckers besides female sex workers, homosexual men, transgender & injecting drug user. The NGO/CBO-led peer outreach model provides prevention services including behavioral change communication, condom promotion, prevention and management of sexually transmitted infections, community mobilization, HIV testing, care, support, treatment etc.

Surveillance of viral hepatitis: Hepatitis a and e are outbreak prone diseases which are reported through Integrated Disease Surveillance Program in the country and there are surveillance centers at centre, state and district levels. Furthermore, institute of liver and biliary sciences has also initiated hepatitis surveillance in coordination with 13 other centers.

Diagnosis / treatment of hepatitis: It has been found that laboratories are used for testing as well as for prevention, care, treatment, safety of blood and products. In India, there was no national action plan till 2018, thus no reporting for the number of hepatitis B and C treated cases.

Sates with Hepatitis C Treatment programs: Punjab has emerged as a model state that has started free HCV treatment. Other states include Assam, Manipur, Tripura and Haryana which have stated limited subsidized treatment to HIV HCV co-infected and HCV infected people but the further coverage has yet to be given to all.

Injection Safety and Infection Control: According to the WHO Regional Action Plan for Viral Hepatitis in South-East Asia: 2016–2021, 50% of all injections will be administered with safety engineering devices by 2020. National Viral Hepatitis Control Program (NVHCP) and State Viral Hepatitis Management Unit (SVHMU) shall be made responsible for strengthen the infection prevention and control practices in both public and private healthcare settings. According to this Regional Action Plan, India including all other member states should reach 90% coverage with birth dose and 95% coverage with Hepatitis B-3, and start implementation of routine Hepatitis B vaccination among high-risk groups.

Pradhan Mantri National Dialysis Program: The program has also made it mandatory to ensure injection safety and hepatitis infection control. The national and state hepatitis controlling agencies will be at core to coordinate with other organizations involved with hepatitis infection control programme.

Biomedical Waste Management: Besides national and state hepatitis controlling agencies will also coordinate with MoEF and all pollution control boards in building capacity for bio-medical waste management.

Treatment Sites for viral hepatitis surveillance: The services under the hepatitis treatment initiative will be delivered through the designated treatment sites that are located within an existing health facility, including state medical colleges. It will utilize the current health care system. However, the extent of services can be graded upon the availability of the expertise in the selected sites. There will be a few sites that will be labeled as Model Treatment Centers (MTC). These will also act as places for referral and mentoring of the other Treatment Centers (TC). The TC centre will preferably be co-located with the sentinel.

Hepatitis B Immunization Program: In India Hepatitis B vaccination was universalized in 2011. In 2017, the Hepatitis -B birth dose coverage amongst institutional deliveries have increased upto 76.36%. Further work in this direction is in progress.

Swachh Bharat Abhiyan: The Ministry of Housing and Urban Affairs has initiated sanitation work in urban and rural areas to eradicate open defecation, manual scavenging, solid waste management, awareness programmes with special focus on tackling viral hepatitis A and E infections.

Laboratories services under NVCP: The facilities used to diagnose hepatitis infections include Recombinant DNA Technology (RDT), Enzyme-Linked Immunosorbent Assay (ELISA), Chemiluminescence Immunoassay (CLIA), Reverse Transcription-Polymerase Chain Reaction (RT-PCR), Genome Sequencing etc. and such facilities are available at all tertiary, district, state and national level healthcare setups.

India’s target for Hepatitis B immunization: India has set targets to cover birth dose of Hepatitis B to 90% and coverage with three doses of Hepatitis B vaccine in infants (B3) upto 95% in 2019-20. However, routine Hepatitis B vaccination among health-care workers has been made available in 2019-20. Furthermore, India has targeted for 100% donated blood units screened for Hepatitis B and C by 2018.

Research: The ICMR and other research institutions mandated by MoHFW have been designated to initiate research programmes to enhance knowledge and skills required for evidence base on multiple epidemics, up-scaled operations, and other such multi-disciplinary themes. The aim of such research programmes is to make utilization of research based knowledge about viral hepatitis and work on its specific indicators. The programmes will also track impact of National Action Plan Combating Viral Hepatitis in India.

Awareness programmes: Safe drinking water and proper sanitation lies at the core of Hepatitis A and E prevention. Awareness generation among masses and health care and sanitation workers about safe injection practices, hepatitis infection spreading routes and means etc are most needed.

Success achieved so far in hepatitis infection eradication:

1. The Institute of Liver & Biliary Sciences (ILBS), New Delhi, recently conducted a major awareness campaign to educate people about hepatitis prevention and treatment as also to provide much-needed psycho social support to patients suffering marginalization in society. The ‘EMPATHY Conclave 2019: Empowering People Against Hepatitis’ brought together leading policy makers, healthcare experts as well as social activists to discuss the way forward in India’s fight against viral Hepatitis.

2. All the intervention made by Government of India and the research agencies have bought in some success in containing the hepatitis infections. Research data has revealed that pregnant women in rural India have shown high acceptability of self-testing for HIV status using an oral fluid-based RDT.

3. An Indian company, Molbio Diagnostics, have launched a chip based PCR test called as ‘Truenat HCV viral load assays’ for quantitative detection and the diagnosis of HCV in whole blood/plasma/serum and such test will aid in the monitoring of HCV viral load of patients with HCV infection.

4. Findings from a Cluster Randomized Trial indicated that integrating of HCV and HIV services improves HCV testing and awareness among people who inject drugs in India.

5. The eleven Indian firms have been given licenses by Gilead Sciences following an approval from US authorities for the drug Epclusa, which treat all genotypes of the HCV. India's capabilities in generic manufacturing, where quality and low cost co-exist hand in hand, Gilead Sciences recognized that to expand patient access and to deploy these life-saving cures to low income countries around the world to the patients who need treatment most.

6. Mylan launched the generic Harvoni® called MyHep LVIR™ in India under a licensing and technology transfer agreement with Gilead and it has been considered as an important addition to our growing Hepato Care segment and it provides an opportunity to offer patients a potential, transformative and simplified single tablet, once-daily treatment regimen to contain the HCV infections.

7. In 2015, India approved sale of generic Hepatitis C drugs, sofosbuvir and ledipasvir to make the treatment affordable and it is expected to increase the flow of patients from the U.S. and Europe to India.

8. In 2015, Abbott India launched 'LiverHealth', an initiative for easy diagnosis of liver health and raising awareness of Hepatitis C in India. Under such initiative, the people in states with high prevalence of HCV infection such as Punjab, Haryana, NCR region and North East gets liver health checked for free through a non-invasive liver imaging technology.

9. Abbott, India also launched the generic version of sofosbuvir, a novel, once-daily oral treatment for people with HCV infection in India.

10. India has been identified as a Model for Resource Limited Settings for eradication of HCV infections.

11. The GAVI Alliance funds have improved vaccine infrastructure for e.g., increased availability of auto-disposable, syringes and vaccine In India, and supported Hepatitis B vaccination in states with high-performing vaccination programmes.

12. The MSD India’s project ‘Sambhav’ was launched aimed to educate patients and their families about HCV and help manage the cost of treatment. Besides MSD India provides subsidies for financing for treatment to eligible patients and counseling to help educate about treatment, adherence and transmission prevention.

13. In India, financial organizations supporting such health issues have a higher presence compared to other institutions such as NGO’s.

14. A study conducted in Punjab, India was presented at International Liver Congress™ 2018 in Paris, France, and such study has validated the efficacy and safety of generic all-oral direct-acting antiviral agents (DAAs) regimens delivered using a decentralized algorithm-based public health model. The results indicate that it is possible to cure more than 90% of individuals with HCV infection in a highly dispersed population using well-trained teams in government medical colleges and district hospitals, and use of DAA’s.

15. Médecins Sans Frontières (MSF), India is an international, independent, medical humanitarian organization that delivers emergency aid to people affected by armed conflict, epidemics, natural and man-made disasters and exclusion from healthcare in more than 70 countries. The MSF team in collaboration with the National AIDS Control Organization in India provided integrated HIV/TB/HCV services. Counselors who have prior experienced in HIV testing and adherence counseling, have been trained to provide HCV pre-test counseling, HCV viral load testing, genotyping and FibroScan® for staging of liver fibrosis.

16, As part of state level campaign to identify more cases of viral hepatitis, a community organization, CONE partnered with state government and pharmaceutical companies to establish testing camps. The camps provided free screening and HCV RNA confirmatory tests together with liver scans for staging of liver fibrosis.

17. In last five years Indian researchers has published more than 1000 scientific publications on Hepatitis research and interventions.