Hepatitis

Progress report on access to hepatitis C treatment - key messages

Focus on overcoming barriers in low- and middle-income countries

Initial progress is uneven

  • Globally, the annual number of people initiating direct-acting antiviral medicines (DAAs) to cure hepatitis C virus (HCV) has increased from around 1 million in 2015 to 1.5 million in 2016. This brings the overall number of people accessing DAAs for HCV to almost 3 million.
  • Nevertheless, the great majority of the estimated 71 million people living with HCV remain untreated. More equitable access to DAAs is urgently needed.
  • Progress in DAA uptake has been uneven across the globe, with a small number of countries accounting for the bulk of the increase. Egypt and Pakistan accounted for about half of all people starting DAA treatment in 2016. There has also been encouraging progress in countries as diverse as Australia, Brazil, China, France, Georgia, Mongolia, Morocco, Rwanda and Spain.
  • Global leaders have committed to eliminating HCV as a major public health threat by aiming to treat 80% of people with HCV by 2030. This points to a long road ahead – but rapid progress is possible if more countries mobilize the much-needed leadership to utilize existing opportunities and expand testing and treatment services.
  • Elimination of viral hepatitis is an integral part of the global movement to achieve the Sustainable Development Goals and deliver health care for all through universal health coverage.

Key drivers for progress identified

  • Access to HCV curative treatment has accelerated in countries such as Australia, Brazil, Egypt, Georgia and Mongolia, which have mobilized a strong government response. These countries have developed national treatment plans; mobilized and allocated resources accordingly; and pursued supportive policies that improve access to treatment, such as regulatory actions, price negotiations, and the integration of laboratory, procurement and supply management processes into broader health systems.
  • More low- and middle-income countries (LMICs) are making affordable generic medicines available, reaping benefits from voluntary licenses, the absence of patents in certain countries and, in the case of Malaysia, TRIPS (Trade-Related Aspects of Intellectual Property Rights) flexibilities. The increasing number of generic manufacturers helps drive competition among suppliers and enables steep reductions in DAA prices.
  • More and better treatments are becoming available. DAAs eliminate HCV from the body by preventing the virus from multiplying. In more than 95% of cases, they cure individuals of HCV, usually within 8–12 weeks. Since 2013, 11 new DAA regimens (5 single-component DAAs and 6 fixed-dose combinations) have been approved for use. Treatment options continue to improve, with new pangenotypic treatments that can cure all 6 major subtypes of HCV now available. Wider access to such pangenotypic treatments would greatly reduce the need for costly genotyping and make it a lot simpler for national policy-makers to both procure and deliver HCV treatment.

Many roadblocks and unseized opportunities exist

  • A large proportion of LMICs have not yet seized opportunities to initiate and scale up HCV treatment services. More than 60% of people in need of HCV curative therapy live in countries where governments could procure more affordable generic DAAs yet treatment remains extremely limited. To respond to HCV in these countries, we need better awareness among policy-makers and stronger political will.
  • DAAs remain unaffordable in many upper-middle- and high-income countries, impeding access to affordable treatment for a large proportion of people in need. Globally, about 38% of people with HCV live in upper-middle- and high-income countries – but HCV treatment remains costly in these countries, as they are typically not included in voluntary licensing agreements.
  • Coverage of screening and diagnosis remains too low, with most people living with HCV still undiagnosed. In 2016, only about 1 in 5 people living with HCV worldwide had been diagnosed. In low-income countries, less than 10% of people with HCV had been diagnosed, compared to over 40% in high-income countries.
  • The cost of HCV testing continues to be a hurdle, not least because it often involves out-of-pocket payment. While prices of rapid diagnostic tests have fallen to as low as US$ 1, confirmatory tests still cost US$ 15–100, depending on the product and country. Affordable, 1-step, point-of-care testing would make it possible to identify far more people in need of treatment.

Next steps: WHO calls on countries to seize opportunities and save lives

  • WHO calls on more LMICs to lead the fight against HCV by developing a strong government response; creating coherent plans to prevent, diagnose and treat HCV; and committing adequate funding to roll out and sustain HCV services. Stringent quality assurance of DAAs is also necessary, along with reliable regulatory processes.
  • WHO is also promoting greater market transparency, as countries require market intelligence on prices used by other countries and buyers. WHO’s progress report includes updated information on DAA prices and registration, as well as a summary of procurement data from selected countries to help country efforts to reduce prices.
  • As the report notes, there is a great opportunity to rapidly increase the uptake of life-saving HCV cure. The treatment can also prevent future epidemics, as HCV is a growing infection with 1.75 million people newly infected each year. We need global partnerships to capitalize on this opportunity.
  • As an immediate next step following the report, WHO will release updated HCV care and treatment guidelines in April 2018, to promote the transition to newer, more effective medicines – particularly pangenotypic DAA regimens that are effective against all 6 major subtypes of HCV. WHO is also moving toward recommending HCV treatment for all individuals diagnosed with HCV infection, regardless of disease stage (except for pregnant women and children under the age of 12 years).
  • These new policy innovations aim to help countries speed up access to HCV treatment and save lives.