Have a Heart, Save My Liver!: Where Are My Diagnostics?

“Elimination of viral hepatitis as a public health threat requires 90% of those infected to be diagnosed and 80% of those diagnosed to be treated." [1]

Of the estimated 71 million people living with chronic hepatitis C virus (HCV), only an estimated 20% are aware of it (5% in low-and middle-income countries) [2]. Untreated, chronic HCV causes liver fibrosis which can progress to cirrhosis or hepatocellular carcinoma (HCC) and death. Approximately, 400 000 persons die each year from HCV-related complications. Recent new effective HCV medicine, direct acting anti-viral (DAAs), have been marketed and, when affordable, help simplifying screening and care pathways for people with chronic HCV. However, oligopoly and high prices of HCV diagnostics continue to be hurdles to reaching hepatitis C elimination, knowing that accessing to HCV tests and diagnostics often involves out-of-pocket payment.

HCV serology antibody tests show whether a person has been exposed to HCV. WHO recommends to focus antibody testing in most-affected populations, in particular people who inject drugs (PWID) and people living with HIV (PLHIV). There are multiple manufacturers of rapid diagnostic tests, and prices have fallen as low as US$ 1 in most countries. [3]

Confirmatory testing
Directly following a positive HCV antibody test result, nucleic acid testing (NAT) should be done to detect the presence of the virus and distinguish persons with chronic HCV infection from those who have spontaneously cleared the infection, approximately 15–45% of persons. These HCV RNA tests are performed through nucleic acid testing (NAT) and real time Polymerase chain reaction (PCR) platforms. Abbott, Roche, and Cepheid are the main NAT companies in market shares for these platforms. The oligopoly situation they share, allow them to set high prices on their NAT platforms, as well as high fees for their maintenance and respective reagents or cartridges. Consequently, tests can be priced from US$15-$30 per test (in the public sector) to US$60-$200 per test (in the private sector), depending on the product and country.

Test of cure
Another HCV RNA test is also recommended to assess the response to hepatitis C treatment, which can double the costs for patient and/or health authorities.

Assessing the degree of liver fibrosis and cirrhosis
"Assessing the degree of liver fibrosis is an important step in the clinical management of persons with HCV infection. Although HCV treatment should be considered for all persons with HCV infection, persons with cirrhosis should be prioritized for treatment because they are at increased risk of HCC and death due to liver failure. Furthermore, the selection of treatment regimens can depend on the presence or absence of cirrhosis." [4]

Two main methods for fibrosis assessment, FibroScan® and FibroTest® are preferable to any other methods. They are recommended by WHO, non-invasive and the most accurate but they are, when available, out of price in many countries although both technologies have been developed and patented by publicly-funded French research i.e., National Institutes of Health and Research (INSERM), Graduate School of Industrial Physics and Chemistry of the city of Paris (ESPCI), Assistance Publique-Hôpitaux de Paris (AP-HP). A FibroScan® device is sold for at least US$100,000 with a yearly maintenance at US$4,700 [5] and the prices charged for the examination are very volatile since they are not linked to the purchase of reagents, from free to more than US$200 [6] ; prices per FibroTest® are unilaterally set by the company Biopredictive at least US$50 per test as it requires outsourcing of interpreting the results. [7]

Genotype testing of the hepatitis C virus is not needed any more if the person receives a “pangenotypic treatment” or treats all genotypes of the virus. However, considering that access to pangenotypic DAAs regimens is still very limited in the majority of countries, genotyping should be added to the HCV diagnostics list in countries for persons who are not benefiting such treatment, before starting to determine the type of treatment and duration. Prices vary from US$13-350 per genotype test. [8]

Price range of HCV diagnostics in standard use

We, people living with hepatitis C, access to medicines activists, and the medical community demand to:
> Roche, Abbott and Cepheid to dramatically drop their prices on viral load tests;
> INSERM, ESPCI and AP-HP to grant open licenses and promote technology transfer to local companies;
> World Health Organization to promote prequalification of open platforms and avoid current monopolistic situation;
> Ministries of Public Health to opt for open platforms, introduce competition and develop local production of reagents and diagnostics technologies.