India

Hepatitis B in India

1.1 Available antiviral for treatment of hepatitis B in India

Antiviral drug available for treatment of hepatitis B in India, along with their year of
availability, are summarized in the following table:
Year of Drug Availability Antiviral Drug
1990 Interferon alpha
1998 Lamivudine
2002 Adefovir
2005 Pegylated interferon and Entecavir
2006 Telbivudine
2008 Tenofovir

These drugs can be used as monotherapy or in combination (two necleos(t)ide analogues NAs
or NAs with interferon). The most popular antiviral drug for treatment of hepatitis B in India
is Entecavir or Tenofovir, administered as monotherapy.1

1.2 Cost of antiviral drugs for hepatitis B in India

The estimated annual cost of antiviral drugs for treatment of hepatitis B in India are outlined
in the table below:
Antiviral drug Estimated annual cost of drugs in USD
Lamivudine $ 76
Adefovir $ 178
Entecavir $ 1,707

Lamivudine and Adevofir are generics. India has no reimbursement scheme for treatment of
hepatitis B.2

1.3 Hepatitis B treatment rates in India

No study document treatment rates for hepatitis B in India. However, treatment adherence is
possibly low. Although antiviral therapy for hepatitis B are available, these drugs are still
considered unaffordable and costly. Without reimbursement schemes, patients have to bear the
cost of these drugs from their own earnings. As a result, patients either skip/split the dose of
the drugs, discontinue therapy, avoid new prescriptions, or delay refills.1

1.4 Impact of treatment on public health of India

In 1995, the average estimated carrier rate of hepatitis B virus is 4% in India. This classifies
India as a country with intermediate endemicity for hepatitis B. Approximately 36 million
Indian people are carriers of hepatitis B.3 Even though antiviral treatment for hepatitis B has
been available since 1990 with lower costs than other Asian countries except Bangladesh
(Table 1), hepatitis B infection continues to remain a significant public health problem in
India.1,2

In 2004, the overall rate of HBsAg positive Indians has been reported to range between 2-8%.
India is still a country with intermediate endemicity of hepatitis B infection. Hepatitis B virus
carriers in India is estimated to be around 40 million people. Higher incidence is found in tribal
areas whose population are mostly illiterate and have poor access to health care resources.
Prevalence of hepatitis B virus in non-tribal populations is 2.4% and in tribal populations as
high as 15.9%. Two-thirds of the chronic hepatitis B infection are HbeAg negative disease with
low or undetectable levels of hepatitis B virus related with silent, slow progression presenting
itself in advanced stages of liver disease (decompensated liver cirrhosis or hepatocellular
carcinoma HCC).4

Hepatitis C in India

2.1 Available antiviral for treatment of hepatitis C in India

Antiviral drug available for treatment of hepatitis C in India, along with their year of
registration, are summarized in the following table:
Year of Registration Antiviral Drug
Not known Simeprevir
13 January 2016 Sofosbuvir
Not known Asunaprevir
14 December 2015 Daclatasvir
Not known Vaniprevir
June 2017 Sofosbuvir/Ledipasvir
Not known Dasabuvir
Not known Ombitasvir/Paritaprevir
Not known Grazoprevir/Elbasvir
Not known Sofosbuvir/Velpatasvir

Sofosbuvir, Daclatasvir, Sofosbuvir/Ledipasvir, and Sofosbuvir/Velpatasvir are registered as

generic drugs in India.5

2.2 Cost of antiviral drugs for hepatitis C in India

Generic prices for the above mentioned direct-acting antivirals (DAAs) are outlined in the table
below:5, 6
Antiviral drug Estimated 12 weeks cost of antiviral drug in USD
Daclatasvir 2016 $ 183
2017 $ 39
Sofosbuvir 2015 $ 750  $ 513
2016 $ 325
 2017 $ 66
Sofosbuvir/Ledipasvir 2016 $ 615
2017 $ 191
Sofosbuvir/Velpatasvir 2018 $260

As India is a global leader in the production of generic DAAs, the cost of these generic DAAs
are lowest in India.7
2.3 Hepatitis C treatment rates in India

Treatment rates of hepatitis C in India are not well documented. Treatment rates in India are
still estimated to be very low. This is possibly due to limited budget allocated to hepatitis C
virus and lack of data on the cost-effectiveness of hepatitis C treatment.8

2.4 Impact of treatment on public health of India

In 2005, there was no date on the overall prevalence of hepatitis C in India. Population-based
studies from various region found prevalence of hepatitis C to be 0.09% to 7.89%.9 In 2015,
the Centre of Disease Analysis estimates that India has the third highest prevalence for hepatitis
C, after China and Pakistan, with 6.2 million people living with hepatitis C virus.10 Hepatitis C
prevalence in India was 0.5% (0.4-0.8%).11 In 2016, the World Health Organization reports
that approximately 6.1 million people are chronically infected with hepatitis C virus in India.6
This data show that new and affordable generic DAAs in India has cause a substantial decrease
in hepatitis C prevalence in India.

Aggarwal R et al adapted a mathematical model to the HCV-infected population in India

comparing no treatment versus treatment with DAAs. They found that compared with no
treatment, the use of generic DAAs in Indian hepatitis C virus patients increase life expectancy
by 8.02 years, increase quality-adjusted life years by 3.89, decrease disability-adjusted life
years (DALYs) by 19.07, and decrease lifetime healthcare costs by $ 1,309 per person. DAA
treatment was cost effective within 2 years and cost saving within 10 years of initiation.8

References
1. Ray G. Current Scenario of Hepatitis B and Its Treatment in India. J Clin Transl Hepatol
2017; 5(3): 277-96. doi: 10.14218/JCTH.2017.00024.
2. Dan YY, Aung MO, Lim SG. The economics of treating chronic hepatitis B in Asia.
Hepatol Int 2008; 2: 284-95. doi: 10.1007/s12072-008-9049-2.
3. Tandon BN, Acharya SK, Tandon A. Epidemiology of hepatitis B virus infection in
India. Gut 1996; 38 (suppl 2): S56-9.
4. Puri P. Tackling the Hepatitis B Disease Burden in India. J Clin Exp Hepatol 2014;
4(4): 312-9.
5. Hill A, Swan T, Timmermasns K. Technology and Market Landscape: Hepatitis C
Medicines August 2017. Geneva: World Health Organization; 2017.
6. Chaillon A, Mehta SR, Hoenigl M, Solomon SS, Vickerman P, Hickman M, et al.
Cost-effectiveness and budgetary impact of HCV treatment with direct-acting
antivirals in India including the risk of reinfection. PLoS ONE 2019; 14(6): 1-16.
7. Iyengar S, Tay-Teo K, Vogler S, Beyer P, Wiktor S, Joncheere KD. Prices, Costs, and
Affordability of New Medicines for Hepatitis C in 30 Countries: An Economic
Analysis. PLoS Med 2016; 13(5): 1-22.
8. Aggarwal R, Chen Q, Goel A, Seguy N, Pendse R, Ayer T, et al. Cost-effectiveness of
hepatitis C treatment using generic direct-acting antivirals available in India. PLoS
ONE 2017; 12(5): 1-15.
9. Mukhopadhya A. Hepatitis C in India. J Biosci 2008; 33: 465-73.
10. World Health Organization. Progress Report on Access to Hepatitis C Treatment:
Focus on Overcoming Barriers in Low-and-Middle Income Countries March 2018.
Geneva: World Health Organization; 2018.
11. The Polaris Observatory HCV Collaborators. Global prevalence and genotype
distribution of hepatitis C virus infection in 2015: a modelling study. Lancet
Gastroenterol Hepatol 2017; 2: 161-76.