Abstract

BackgroundThe current low access to virological testing to confirm chronic viraemic HCV infection in low- and middle-income countries (LMIC) is limiting the rollout of hepatitis C (HCV) care. Existing tests are complex, costly and require sophisticated laboratory infrastructure. Diagnostic manufacturers need guidance on the optimal characteristics a virological test needs to have to ensure the greatest impact on HCV diagnosis and treatment in LMIC. Our objective was to develop a target product profile (TPP) for diagnosis of HCV viraemia using a global stakeholder consensus-based approach.MethodsBased on the standardised process established to develop consensus-based TPPs, we followed five key steps. (i) Identifying key potential global stakeholders for consultation and input into the TPP development process. (ii) Informal priority-setting exercise with key experts to identify the needs that should be the highest priority for the TPP development; (iii) Defining the key TPP domains (scope, performance and operational characteristics and price). (iv) Delphi-like process with larger group of key stakeholder to facilitate feedback on the key TPP criteria and consensus building based on pre-defined consensus criteria. (v) A final consensus-gathering meeting for discussions around disputed criteria. A complementary values and preferences survey helped to assess trade-offs between different key characteristics.ResultsThe following key attributes for the TPP for a test to confirm HCV viraemic infection were identified: The scope defined is for both HCV detection as well as confirmation of cure. The timeline of development for tests envisioned in the TPP is 5 years. The test should be developed for use by health-care workers or laboratory technicians with limited training in countries with a medium to high prevalence of HCV (1.5–3.5% and >3.5%) and in high-risk populations in low prevalence settings (<1.5%). A clinical sensitivity at a minimum of 90% is considered sufficient (analytical sensitivity of the equivalent of 3000 IU/ml), particularly if the test increases access to testing through an affordable price, increase ease-of-use and feasibility on capillary blood. Polyvalency would be optimal (i.e. ability to test for HIV and others). The only characteristic that full agreement could not be achieved on was the price for a virological test. Discussants felt that to reach the optimal target price substantial trade-offs had to be made (e.g. in regards to sensitivity and integration).ConclusionThe TPP and V&P survey results define the need for an easy-to-use, low cost test to increase access to diagnosis and linkage to care in LMIC.

Highlights

  • The current low access to virological testing to confirm chronic viraemic Hepatitis C virus (HCV) infection in low- and middle-income countries (LMIC) is limiting the rollout of hepatitis C (HCV) care

  • The timeline of development for tests envisioned in the target product profile (TPP) is 5 years

  • Stakeholder participants in TPP development Of the 50 organizations/individuals invited to participate in the Delphi-like TPP consultation, 36 responded to the HCV RNA TPP and 26 to the cAg TPP, and 35 attended the consensus meeting in Vienna

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Summary

Introduction

The current low access to virological testing to confirm chronic viraemic HCV infection in low- and middle-income countries (LMIC) is limiting the rollout of hepatitis C (HCV) care. Hepatitis C virus (HCV) causes both acute and chronic infection, and is a leading cause of liver-related mortality worldwide [1]. The remaining 55–85% of persons who do not clear HCV within six months are defined as having chronic viraemic infection and require treatment to prevent the substantial liver-related morbidity and mortality. There has been recent expansion of access in lowand middle income countries (LMIC) as a result of the availability of generic DAAs [5,6,7] resulting in substantial price reductions and price of US $ 100–250 for a 2-drug treatment course is within reach [8, 9]

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