Generic DAAs: A Step Closer to Eradicating HCV in Lower-Income Countries
Low-priced direct-acting antivirals provide a win-win situation, warranting the use of public money to fund it.
Worldwide, >70 million people are infected with hepatitis C virus (HCV), with low- and middle-income countries from South Asia, East Asia, North Africa, the Middle East, and Southeast Asia accounting for >80% of the global HCV burden.1 In India alone, between 6 and 11 million people are infected.1 Most of these cases are attributed to blood transfusions and unsafe medical practices, and transmission often goes unrecognized until patients develop advanced liver disease.2,3 On presentation, cirrhosis has been reported in 56% of patients and hepatocellular carcinoma in 7%.3 In 2015, approximately 60,000 deaths in India were attributed to HCV alone.2
Although direct-acting antivirals (DAAs) have shown curative response rates >95%, the high cost of these treatments, which ranges from $40,000 to $85,000 in high-income countries, makes them cost-prohibitive to most patients in low- and middle-income countries.1,2 To combat this problem, the pharmaceutical companies that developed these drugs have enabled generic versions to be produced in low- and lower-middle-income counties. In India, production of generic sofosbuvir started in 2014 and production of daclatasvir and ledipasvir started in 2016.4 Costs for a 12-week course of these generics range from approximately $300 for daclatasvir to $1100 for ledipasvir.4 Despite cost hurdles being largely overcome, only a small portion of patients requiring these treatments have received them in India.
Infectious Disease Advisor had the opportunity to discuss generic DAAs with Jagpreet Chhatwal, PhD, assistant professor at Harvard Medical School and senior scientist at Massachusetts General Hospital in Boston. Dr Chhatwal is corresponding author of a recently published international study in PLoS ONE that examines the costs of generic HCV drugs in India.5
Infectious Disease Advisor: Despite generic DAAs being available in India, why have so few people received them?
Jagpreet Chhatwal, PhD: One of the primary challenges is the lack of funding to scale-up treatment to millions of individuals who need it. Second, only a fraction (around 5%) of HCV-infected people are aware of their infection, and those who are not aware will not be able to avail themselves of the benefits of new DAAs. National screening guidelines are needed in India to diagnose and treat HCV.
Infectious Disease Advisor: Your study assessed the cost-effectiveness of HCV treatment using generic DAAs available in India. What were your findings?
Dr Chhatwal: We anticipated that generic DAAs available in India (and other low-/middle-income countries) will be cost-effective. In fact, we were pleasantly surprised that these DAAs are not merely cost-effective but cost-saving, meaning they improve outcomes and save costs at the same time by preventing advanced sequelae of HCV (eg, liver cancer).5 In addition, we found that the up-front cost of DAAs will be recovered as soon as 2 years in patients with cirrhosis.5
Infectious Disease Advisor: Do you think use of generic DAAs will improve in India based on your findings? Do you know of any actions currently being taken to improve access to these medications?
Dr Chhatwal: Yes, we strongly believe that the use of generic DAAs will increase in India. Our study provides a compelling case to invest in HCV treatment: Low-priced DAAs provide a win-win situation, warranting the use of public money to fund it. An initiative was launched in 2016 by the government of Punjab, which is making HCV treatment available at a subsidized rate or free to selected patients.6 Such initiatives also provide motivation to local residents to get screened, even when there are no standard screening guidelines. The cost of DAAs have come down to as low as $109, which makes treatment even more cost-saving.
Infectious Disease Advisor: Generics are unlikely to be available in the United States for some time, and healthcare costs are a major concern for many here as well. Do you think this might lead some to seek treatment overseas?
Dr Chhatwal: This is an interesting proposition, but I'm not aware of a systematic flow of patients from the United States to India for HCV treatment. However, I have heard anecdotally of such medical tourism occurring from middle-income countries (eg, Turkey) to India.
Infectious Disease Advisor: Do you think the World Health Organization goal of HCV elimination by 2030 is feasible? If so, how do you see us getting there?
Dr Chhatwal: It all depends on what actions we take now. Some countries (eg, Australia, United States) are far ahead on the track toward HCV elimination, but most countries do not yet have a plan to manage HCV. First, countries need cost-effective screening guidelines to diagnose HCV-infected patients. Second, there is a need to provide resources to scale-up HCV treatment at the population level. Even with low-cost generic DAAs, the budget needed to treat HCV will be huge. Third, effective interventions are needed to reduce HCV transmission among high-risk individuals. Finally, perhaps most important, the cost of diagnostic tests should be reduced substantially to make national screening programs affordable and cost-effective.
- Dhiman RK. Future of therapy for hepatitis C in India: a matter of accessibility and affordability? J Clin Exp Hepatol. 2014;4:85-86.
- Premkumar M, Grover GS, Dhiman RK. Chronic hepatitis C: do generics work as well as branded drugs? J Clin Exp Hepatol. 2017;7:253-261.
- Gupta V, Kumar A, Sharma P, Bansal N, Singla V, Arora A. Most patients of hepatitis C virus infection in India present late for interferon-based antiviral treatment: an epidemiological study of 777 patients from a North Indian tertiary care center. J Clin Exp Hepatol. 2015;5:134-141.
- amfAR. Indian generic companies begin production on two new hepatitis treatments. January 20, 2016. Accessed December 11, 2017.
- Aggarwal R, Chen Q, Goel A, et al. Cost-effectiveness of hepatitis C treatment using generic direct-acting antivirals available in India. PLoS ONE. 2017;12:e0176503.
- Dhiman RK, Satsangi S, Grover GS, Puri P. Tackling the hepatitis C disease burden in Punjab, India. J Clin Expe Hepatol. 2016;6:224-232.