| Literature DB >> 33328200 |
Caroline E Boeke1, Clement Adesigbin2, Chukwuemeka Agwuocha3, Atiek Anartati4, Hlaing Thazin Aung5, Khin Sanda Aung6, Gagandeep Singh Grover7, Dang Ngo8, Emi Okamoto9, Alida Ngwije10, Sabin Nsanzimana11, Siddharth Sindhwani12, Grace Singh13, Ly Penh Sun14, Nguyen Van Kinh15, Wiendra Waworuntu16, Craig McClure13.
Abstract
With political will, modest financial investment and effective technical assistance, public sector hepatitis C virus (HCV) programmes can be established in low- and middle-income countries as a first step towards elimination. Seven countries, with support from the Clinton Health Access Initiative (CHAI) and partners, have expanded access to HCV treatment by combining programme simplification with market shaping to reduce commodity prices. CHAI has supported a multipronged approach to HCV programme launch in Cambodia, India, Indonesia, Myanmar, Nigeria, Rwanda and Vietnam including pricing negotiations with suppliers, policy development, fast-track registrations of quality-assured generics, financing advocacy and strengthened service delivery. Governments are leading programme implementation, leveraging HIV programme infrastructure/financing and focusing on higher-HCV prevalence populations like people living with HIV, people who inject drugs and prisoners. This manuscript aims to describe programme structure and strategies, highlight current commodity costs and outline testing and treatment volumes across these countries. Across countries, commodity costs have fallen from >US$100 per diagnostic test and US$750-US$900 per 12-week pan-genotypic direct-acting antiviral regimen to as low as US$80 per-cure commodity package, including WHO-prequalified generic drugs (sofosbuvir + daclatasvir). As of December 2019, 5900+ healthcare workers were trained, 2 209 209 patients were screened, and 120 522 patients initiated treatment. The cure (SVR12) rate was >90%, including at lower-tier facilities. Programmes are successfully implementing simplified, decentralised public health approaches. Combined with political will and affordable pricing, these efforts can translate into commitments to achieve global targets. However, to achieve elimination, additional investment in scale-up is required. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.Entities:
Keywords: diagnostics and tools; public health; treatment; viral hepatitis
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Year: 2020 PMID: 33328200 PMCID: PMC7745326 DOI: 10.1136/bmjgh-2020-003767
Source DB: PubMed Journal: BMJ Glob Health ISSN: 2059-7908
Characteristics of public sector HCV programs by country as of December 2019
| Cambodia | India | Indonesia | Myanmar | Nigeria | Rwanda | Vietnam | |
| 2018 | 2018 | 2017 | 2017 | 2015 | 2014 | 2017 | |
| All provinces | All states* | 15 provinces | 8 states and regions | 1 state | Nationwide | 7 provinces | |
| 68 | 90 | 37 | 18 clinics in 12 sites | 19 | 552 | 9 | |
| 319 | 3000+ | 310 HCWs+135 prison peer educators | 300 | 548 | 792 | 689 | |
| Phased rollout of HCV care to all ART sites across all 25 provinces | HCV care rolled out to national state (medical colleges) and tertiary (district) level hospitals using a train the trainer approach with 100 master trainers; screening increasingly decentralised through integration | Screening mostly at primary care facilities with some providing VL testing; treatment provided at secondary and tertiary level facilities | Only secondary and tertiary hospitals provide HCV care | Only secondary and tertiary hospitals provide HCV care | HCV care at health centres; nurses trained to prescribe treatment | Only secondary and tertiary hospitals provide HCV care | |
| National Centre for HIV/AIDS, Dermatology and STDs | National Viral Hepatitis Control Programme | Sub-directorate of Hepatitis and Digestive Infection, MOH | National Hepatitis Control Programme, MOHS | National Viral Hepatitis Control Programme—a unit within National HIV/AIDS and STI Control Programme | Rwanda Biomedical Center, MOH | No national programme; programme led by the National Hospital for Tropical Diseases | |
| Global Fund (HIV/HCV coinfected patients only) | Formal national budget line with partial allocation to states (state cofinancing requirement) | Formal national budget line | Formal national budget line | No national budget line | Formal budget line; local and international fundraising | No national budget line but HCV services and commodities reimbursable under national health insurance | |
| 2017: Clinical guidelines for HIV/HCV coinfected patients | 2018: National clinical guidelines | 2015: National action plan | 2017: National strategic plan, action plan and M&E plan | 2015: National policy | 2015 to 2018: National policy and clinical guidelines | 2015 to 2019: National strategic plan | |
| PLHIV on ART | General adult population, PLHIV, PWIDs, prisoners, patients from private sector tested positive | PWIDs, prisoners, PLHIV, patients at liver wards, patients at haemodialysis wards, blood donors, HCWs | Patients at medical wards, PLHIV, PWIDs, men who have sex with men, female sex workers, multitransfused recipients, HCWs, haemodialysis patients, patients from private sector or blood donors tested positive and eligible for public sector care | General adult population (provider initiated testing and counselling), PLHIV, PWIDs | Campaigns targeting PLHIV (2016 campaign), prisoners and people 45+ years (2017 campaign), people 22–44 years in high-risk districts (2018 campaign), adults 15+ years (2019 onwards) | PLHIV, PWIDs, HCWs, patients at liver wards; 2019 campaign targeting general population in one province | |
| Coinfection programme led by HIV programme; fully integrated with ART sites and services | Punjab and Haryana have initiated integration of services for screening of high-risk groups in ART clinics, opioid substitution therapy sites and prisons | Multidisease testing on diagnostics platforms across tuberculosis/HIV/HCV in all sites that provide diagnostics services for these diseases | Pilot on integration of HCV VL testing alongside HIV VL and early infant diagnosis testing conducted at national reference laboratory | Integrated diagnostic platforms; use of tuberculosis GeneXpert platforms for hepatitis in Nasarawa; integrated HIV online platform (HIV PACE ECHO) for learning to deliver viral hepatitis lectures | Integrated diagnostic system across programmes, leveraging HIV infrastructure | Multidisease testing on diagnostics platforms at select hospitals | |
| Free of charge | Free of charge | Free of charge if in public hospital and using national insurance; if not using national insurance patients have to pay for consumables (US$1.70 for RDT, US$6 for VL) | Free of charge (PPP patients pay for VL and treatment) | Out of pocket | Free of charge except for other pretreatment tests such as CT scans for liver damage (10% insurance copay) | Out of pocket or insurance copay | |
| Aggregate reporting of paper-based site records to government | Custom web-based system | Web-based national hepatitis health management information system (Sihepi) | Open-sourced facility-based health management information system (OpenMRS) | None (three hepatitis indicators included in DHIS2 as of 2019) | Excel-based system (through 2019); DHIS2 (2020 onwards) | None (cross-disease national surveillance system in place but limited HCV indicators and not widely in use) |
*CHAI support has been focused primarily in Punjab.
ART, antiretroviral therapy; CHAI, Clinton Health Access Initiative; ECHO, Extension for Community Healthcare Outcomes; HCV, hepatitis C virus; HCW, healthcare worker; M&E, monitoring and evaluation; MOH, Ministry of Health; PACE, Partnership for Achieving Control of Epidemic; PLHIV, people living with HIV; PPP, public private partnership; PWID, people who inject drugs; RDT, rapid diagnostic test; STD, sexually transmitted disease; STI, sexually transmitted infection; VL, viral load.
Public sector product procurement pricing for quality-assured products from in-country distributors as of December 2019 (US$)*
| Rapid diagnostic test | Viral load test | 12-week direct-acting antiviral regimen | |
| Cambodia | US$1 | US$17 | US$231 |
| India (Punjab only)† | US$0.30 | US$5.90 | US$39 |
| Indonesia | US$0.94 | US$30.48 | US$750 |
| Myanmar | US$0.70 | US$25 | US$93 |
| Nigeria | US$1.80 | US$22 | US$207 |
| Rwanda | US$0.75 | US$9.36 | US$60 |
| Vietnam‡ | US$1.30 | US$22.14 | US$900 |
*The same commodities may be more expensive in the private sector.
†Prices are for locally manufactured products (not necessarily quality assured). Viral load test price derived using 50% of the bundled price for viral load test and SVR12 test. A 12-week direct-acting antiviral regimen cost is for a locally manufactured, quality-controlled product.
‡Pricing reflects the lowest price that patients can access in a public sector facility.
Figure 1Aggregate cascade of care data between programme initiation (2014–2017, country dependent) and December 2019: all country summary (A) and numbers by country (B–H).1 1Population size estimates from 201929 and HCV prevalence estimates for each country are as follows: Cambodia: population: 16 486 542 prevalence: 1.6%1; India: population: 1 366 417 754; prevalence: 0.85%9; Indonesia population: 270 625 568: prevalence: 1.0%11; Myanmar: population: 54 045 420; prevalence: 2.65%12; Nigeria: population: 200 963 599; prevalence: 1.1%13; Rwanda: population: 12 626 950; prevalence: 4.0%15; Vietnam: population: 96 462 106; prevalence: 1.0%–3.3%.16 Data in the figure from India are from the Punjab programme only. Data discrepancies across columns in some countries may be explained by the following factors: in Punjab, many facilities did not collect data on all patients screened, only the anti-HCV antibody positive patients. In several countries, only screening and treatment volumes were initially reported (not other indicators across the cascade of care), and therefore, the total number of patients reported as initiating treatment exceeded the number of patients with an elevated VL. In Cambodia, the number of confirmatory VL tests was higher than the number who screened positive because many individuals had already received RDTs previously through other mechanisms. Some programmes such as Rwanda did not historically distinguish between confirmatory VL testing and SVR12 testing, and therefore, did not have accurate SVR12 numbers. In Vietnam, numbers were combined across different data sources, leading the number of patients who were cured to look larger than the number of patients with an SVR12 test. Of note, in some countries, screening and viral load testing were conducted among people identified as high risk and subsequently tested, and therefore the proportion of tests that were positive does not equate to population prevalence of anti-HCV antibodies or viraemia. HCV, hepatitis C virus; RDT, rapid diagnostic tests; VL, viral load.