Essential medicines and health products

Key facts on hepatitis C treatment

From Global report on access to hepatitis C treatment: focus on overcoming barriers
27 October 2016

Approximately 80 million people are estimated to have chronic hepatitis C virus (HCV) infection and an estimated 700 000 of them die untreated every year.

Despite the range and severity of the epidemic caused by HCV, the global response to reduce the burden of this disease has been very limited until now.

In 2013-2014, a new class of oral medicines, called direct-acting antivirals (DAAs), entered the market and revolutionized HCV treatment.

DAAs have an over 95% cure rate, have fewer side effects than previous, less effective therapies and patients can be fully cured with an eight to 12 week course of the medicines.

Over 1 million people today are receiving or have received treatment with DAAs in low- and middle- income countries.

Although the cost of producing DAAs is low, market entry prices for these treatments were extremely high, and have continued to remain high in many countries.

Sofosbuvir, which is the backbone of most HCV treatment regimens, was introduced in the United States in 2013 and priced at US$ 1000 per pill, taking the standard 12-week treatment required to USD 84 000 per person.

While the health benefits of these new medicines are undeniable, they are still, today, out of reach of the majority of people infected with HCV, especially in upper-middle-income countries, which together bear the largest burden of the epidemic, and in high-income countries, most of which are forced to ration treatment.

Price reductions

For low-income and lower-middle-income countries, prices have dropped dramatically, leading to a scale-up of treatment.

The reasons for this are:
  • Gilead has granted licenses for sofosbuvir and ledipasvir to Indian generic manufacturers allowing 101 low- or lower-middle-income countries and Bristol-Myers Squibb has entered into a license agreement for daclatasvir with the Medicine Patent Pool, allowing 112 countries to purchase generic versions of the medicine
  • countries where patents for the medicines were not filed or granted, like Egypt or Morocco, have been able to buy or locally produce generic versions of the medicines
  • some countries where the patents for the medicines are granted, have negotiated price reductions with the innovator companies.

The steepest price decrease can be observed in countries with generic formulations of DAAs.

In Egypt, with one of the world’s highest prevalence rates of hepatitis C, the price for a 28-day supply of sofosbuvir dropped from US$ 300 in 2014 to US$ 51 in 2016, allowing for 170 000 people to be treated in 2015, and 500 000 between January and September 2016.

For daclatasvir, the price for a 28-day supply of a generic formulation dropped to US$ 120 in Morocco, US$ 61 in India and down to US$ 7 in Egypt.

In January 2016, the lowest price for a 28-day supply of a generic combination of sofosbuvir/ledipasvir by Indian licensees of the originator company for the local Indian market was US$ 205; by April 2016, it had dropped to US$ 169.

The lowest price reported for a 28-day supply of sofosbuvir in January 2016 from a local generic producer was US$ 15 in Pakistan.

High-income and upper–middle-income countries, in particular, are facing high prices that have led to rationing of treatment.

A study of HCV treatment in OECD countries found that the total cost of treating all patients, adjusted for currency differences and national wealth, ranged from 10.5% (the Netherlands) to 190.5% (Poland) of the current annual cost for all medicines among the countries studied.

In five OECD countries where prices are high and the burden of disease is large, the total cost of treating all infected patients would be more than the cost of all other medicines put together. If a patient had to pay for the treatment out of pocket, the total cost of a full course of sofosbuvir alone would be equivalent to one year or more of average earnings.

The potential total cost of treatment presents a financial and ethical dilemma for payers and physicians. Some national health systems have therefore restricted access to these medicines to small groups of patients, despite the fact that almost all patients with chronic hepatitis C infection are likely to benefit from treatment with these medicines.

WHO response to date:
  • WHO’s Global Health Sector Strategy on Viral Hepatitis, 2016–2021 provides guidance for countries to tackle HCV, from diagnosis to treatment and care delivery.
  • In 2016, WHO issued updated treatment guidelines for hepatitis C, recommending DAAs.
  • In 2015, WHO included a number of the new DAAs in the Model list of Essential Medicines, thus signalling to countries that they should make DAAs available and affordable in their health systems, and allowing them some leverage to negotiate prices and seek other strategies to make the medicines more widely available.
  • The WHO Prequalification Programme has expanded to include evaluations of DAAs to encourage quality generic production. On 14 October, the programme prequalified the first DAA – daclatasvir, by the originator company, Bristol-Myers Squibb. Several generics are in the pipeline.
  • The Global report on access to hepatitis C treatment: focus on overcoming barriers provides strategic information on registration status, the patent situation and pricing to facilitate access to the new DAAs. It is also a commitment to providing assistance to countries so that they can develop and implement plans to halt transmission of the virus, and to provide universal access to safe, affordable and effective care and treatment.
In addition, WHO has:
  • enabled capacity building and technical support for implementation and scale up of treatment in countries.
  • developed and disseminated new guidance on hepatitis national planning, surveillance, monitoring and evaluation.
  • assessed and published the patent situation of the new DAAs to guide Member States in their procurement decisions.
  • convened consultations with DAA manufacturers and with partner organizations to advocate for adequate manufacturing capacity of producers.