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Access to hepatitis C treatments is increasing, so are therapeutic options, but most of those living with the disease are not diagnosed and thus remain untreated, the World Health Organization found in a new report. Upper-middle income and high-income countries continue to pay high prices, impeding equitable access, and those countries which have been most successful in increasing access have mobilised a strong government response, the report found.

The World Health Organization in the past week published its second progress report on access to hepatitis C treatment. The report focuses on overcoming barriers in low-and middle-income countries.

According to the report, access to “highly effective direct-acting antivirals” (DAA) for the treatment of hepatitis C is increasing and has the potential to end hepatitis C virus (HCV) epidemics. However, a small number of countries are responsible for the bulk of that increase. Egypt and Pakistan accounted for about half of all people who started treatment in 2016, the report says, though it underlined progress in countries such as Australia, Brazil, China, France, Georgia, Mongolia, Morocco, Rwanda and Spain.

Increased competition from generic manufacturers since 2015 has led to steep price reductions, but some 60 percent of people with HCV infection now live in countries that could procure more affordable generic treatments, the report notes.

Prices in upper-middle income and high-income countries remain high, however, impeding equitable access to safe and effective treatment, the report underlines. Those countries, such as Brazil, China, Colombia, Mexico and Turkey, are typically not included in licence agreements and represent 38 percent of people living with HCV globally. it says.

“Countries that try to negotiate reduced prices with manufacturers require market intelligence on what other countries and buyers are paying,” the report says. It includes updated information on DAA prices and registration collected from “a selection” of countries, and a summary of procurement data.

The report also found that the majority of the estimated 71 million people living with HCV remain untreated, mostly because they are not diagnosed. Globally, it says, only about one in five people living with HCV in 2016 had been diagnosed, and in low-income countries, less than 10 percent of people infected with HCV had been diagnosed. Some 40 percent are diagnosed in high-income countries, says the report.

The WHO analysed country experiences in the treatment of HCV, and found that while access to affordable treatment is key, countries need a strong government response, national plans for preventing. diagnosing and treating HCV, and adequate financing.

The report explains that treatment expansion has been most successful in countries that have mobilised a strong government response, such as in Australia, Brazil, Egypt and Mongolia.

According to the report, financing should increase in most countries, and should come from domestic sources as part of a broader push toward universal health coverage.

“Unlike for the HIV, tuberculosis or malaria, international solidarity is still largely lacking in the viral hepatitis response,” the report found.

Treatment options for hepatitis C have increased and improved, with eleven DAA regimens which have received regulatory approval from “at least one stringent regulatory authority since 2013,” it says. The report suggests that originator and generic manufacturers seek WHO prequalification for their HCV products so countries can procure from a range of quality-assured diagnostic and treatment options.

As of February 2018, WHO had prequalified the sofosbuvir tablets (Gilead) from three generic companies as well as daclatasvir tablets (Bristol-Myers Squibb) of the originator company. However, the report points out, the majority of generic DDAs are neither WHO-prequalified nor authorised by a “stringent regulatory authority.”

The report also underlines WHO’s efforts to support the scaling up of hepatitis C treatments. For example, WHO assists in drafting and implementing national testing and treatment policies, and has edited a “WHO Manual for the development and assessment of national viral hepatitis plans: a provisional document.”

WHO provides technical assistance for scaling up treatment and addressing price and intellectual property-related barriers, the report says. WHO also documents the status of the HCV response, trends in access to and use of DDAs, and new developments related to prices, registration, intellectual property rights and procurement of DAAs.