Hepatitis C is a global disease with an estimated prevalence rate of about 2.8% worldwide. There are however significant variations in the prevalence rate by country with most low and middle income countries bearing the bulk of the disease burden. Countries with the highest Hepatitis C prevalence ≥5% include Egypt 4.4-15.0%, Gabon 4.9-11.2%, Uzbekistan 11.3%, Cameroon 4.9-13.8%, Mongolia 9.6-10.8%, Pakistan 6.8%, Nigeria 3.1–8.4%, Georgia 6.7%. Whilst treatment is available for Hepatitis C access to treatment in low and middle income countries is mostly non-existent or only available to a small minority of individuals.
Current available therapies for Hepatitis C are highly effective with cure rates of 95% and above when used appropriately. Whilst effective therapy is available with such high cure rates access to these drugs unfortunately is not available in most high prevalence settings. The major reason at this time is most likely cost; current available drugs for treatment of hepatitis C include Harvoni, Zepatier, Mavyret and Epclusa which are all combinations of agents that inhibit the activity of viral enzymes and as such effectively stop viral replication in the body with subsequent elimination. The treatment regimens range from 8 weeks to 12 weeks in most cases with a few individual cases requiring 16 – 24 weeks of treatment. In the United States today treatment regimens for treatment of Hepatitis C cost about $54,000 to $94,000 for a full 12 week course based on drug used.
On account of the high cost of these agents treatment is not available to most hepatitis C infected individuals. In the US both medicaid programs and private insurance carriers have different criteria that they use to determine which type of patient with hepatitis C deserves treatment. Some insurance carriers deny treatment to patients for problems such as alcohol use even though clinical guidelines have removed lack of alcohol use as a requirement for treatment. Another common reason why patients are denied treatment include having minimal degrees of liver damage from the disease. This is categorized into different stages F-0 – F4 where F-0 suggests no scarring and F-4 is considered equivalent to cirrhosis. Some insurance schemes would only treat individuals who have scarring equivalent to F-2 and beyond whilst others use a cut-off of F-3. What this means is that a lot of patients with Hepatitis C in the US have to wait till they get sicker before they get treatment.
All these gimmicks used by insurance companies sound like rationing of care in a country that has always been scared of rationing in socialized medicine. Whilst America rations treatment for hepatitis C countries like the Netherlands and Switzerland with socialized systems of medicine and gearing towards elimination with expanded access to treatment as far back as July 2017 in Switzerland and Netherlands from November 2015. In the US I know we are going to continue to struggle and nickel and dime ourselves whilst our sick patients suffer. Below is our current profile of Hepatitis C treatment based on a study from 2014.
In epidemiological terms we have all the conditions required to eliminate Hepatitis;
- An effective intervention to interrupt transmission of the agent – Current direct antiviral agents for Hepatitis C fit that bill
- An accurate diagnostic test to identify carriers – The Hepatitis C Antibody test and the Reflex RNA fits that bill and GILEAD Sciences is assisting different health centers across the country screen individuals in their nation wide FOCUS Program
- Human beings should be essential for the life-cycle of the agent – Hepatitis C virus is only known to affect humans and does not require a insect vector like its relatives Dengue and Yellow Fever
Globally the cost of therapy is out of reach for most countries and as such elimination would require a concerted effort by both governments across the world, organizations such as WHO and CDC and the benevolence of pharmaceutical companies to achieve elimination. In 2017 Pharco Pharmaceuticals an Egyptian drug company signed a technology transfer agreement with Medicines Patent Pool a UN backed public health organization that would make their drug Ravidasvir a NS5A inhibitor in late stage clinical trials widely available in most low and middle income countries once approved for clinical use. GILEAD sciences is pursuing different methodologies for improving access to their medications across the world some of which are currently being piloted in different countries.
Some ideas being pursued include;
- In country generic products in places like Egypt and Pakistan.
- Flat pricing of Sovaldi and Harvoni in low and middle income countries
- India based partners licensed to produce-generics to over 101 countries with high prevalence of Hepatitis C
Currently in the US less than 10% of the 3.5 million infected individuals have been treated and cured. Worldwide about 7% of all those infected have been cured. The tools and the nature of this disease suggests that elimination is feasible, we would only need concerted efforts by all those involved to achieve this. We need physicians, insurance companies and other payers, local governments and ministries of health across the world to get onboard with this venture.
What can we do to assist with this?
- If you have hepatitis C get treated, if you get denied treatment call your insurance company or ask your provider to call on your behalf
- If you work for a local health ministry in a low to middle income nation contact pharmaceutical companies like Gilead, Merck and Abbvie find out what you need to do to qualify for reduced drug pricing.
- If you are a doctor, primary care or family physician get comfortable with the use of the new agents and treat your own patients who have hepatitis C. The IDSA & AASLD resource can guide you through the process. Follow the link below.
By Dr. Leonard Sowah, an internal medicine physician in Baltimore, Maryland