Hepatitis C Infection Among Maintenance Hemodialysis Patients in Low Resource Settings: Time to Reorient Public Payer Programs

Dear Editor,

Between 1990-2022, the prevalence of hepatitis C virus (HCV) infection among patients on maintenance hemodialysis (MHD) globally and in India has been estimated to be 24.3% and 19.3%, respectively. In low- and middle-income countries (LMICs), the prevalence is 26.8%, compared to 24.4% in high-income countries (HICs).¹ A survey in 2019 among patients on HD showed HCV seropositivity from 1.4% to 28.3% and 4.7% to 41.9% in developed and developing countries, respectively.² The latter have multiple risk factors, such as poor infrastructure, overcrowding, suboptimal infection control practices, hygiene and waste management issues, and inadequately trained staff. All these are drivers of HCV transmission within dialysis centres.³ The standard of diagnosis and treatment remains inaccessible and unaffordable for health systems in LMICS. Hence, the objectives of this study are to describe the implementation of screening and treatment intervention for hepatitis C and to evaluate the cost of screening and treating HCV in patients on dialysis in India.

We conducted this study in six dialysis centers, operating under a public-private partnership, with 795 patients in Andhra Pradesh. The HCV prevalence was from 8 to 10% between May 2022 and April 2023. The selection of patients has been described in Figure 1. HCV IgG ELISA detected hepatitis C positivity in 69 patients who were then screened with the TaqMan HCV quantitative test (quantitative HCV RNA). Methodology: A real-time PCR kit was used for HCV quantification (COBAS AmpliPrep COBAS TaqMan kit). The analytical detection limit of the assay is ≥15 IU/mL, with a hit rate ≥95%).

Close

Figure 1:

Selection of patients for the study.

Export to PPT

We developed a 4-year state-transition model to estimate the costs and benefits associated with implementing a screening (ELISA followed by HCV RNA) and treatment intervention for HCV among dialysis patients compared with the no-intervention case. We modelled a cohort of 2,000 dialysis patients in the first year. Inputs for the model were primarily drawn from the observational study, as shown in Table 1. The model assumes that once cured, HCV does not recur in that patient for the period and that the intervention results in a 3% per cent annual drop in the HCV incidence, whereas in the no-intervention arm, that there is a 3% increase in incidence annually due to lack of screening and active treatment by patients with undetected cases. The intervention has been diagrammatically represented in Figure 2.

Close

Figure 2:

Intervention.

Export to PPT

Costs were estimated across all four stages of the model. Dialysis frequency was assumed to be eight sessions/patient/month. For HCV-positive patients, a separate dialyzer was used for each session to prevent cross-contamination, significantly increasing costs. In contrast, for HCV-negative patients, the dialyzer was reused for 8 sessions. Survival rates of dialysis patients and quality-associated life years (QALY) for patients with HCV were derived from published literature.

Among 795 patients registered for HD in six selected centres, 69 were Hepatitis C IgG ELISA-positive. The inclusion criteria were satisfied by 49/69 patients. Figure 1 shows the patients chosen for screening and treating hepatitis C.

The age range of these 17 patients was 23 to 60 years, with a mean age of 45.47 ± 9.45 years. Of the 76% males, 53% were on dialysis thrice weekly for a mean duration of 4.1 years on MHD. The mean HCV RNA quantitative value decreased from a mean of 2,703,204 IU/mL to undetectable levels after treatment. The total cost of viral markers screening before treatment (Rs. 798), HCV RNA testing before and after treatment (Rs. 2300), and medications (Rs. 17,472 for 4 weeks) amounted to Rs. 20,570 per patient.

Cost estimates were generated for both the intervention and no-intervention scenarios. The costs for 2,000 patients in the no-intervention and intervention arms were Rs. 2,55,48,465 and Rs. 5,14,21,872, respectively. The cost per person for the no-intervention and intervention arms was Rs. 12,774 and Rs. 25,711, respectively, reflecting a 101.3% increase from the base strategy for a 0.12 QALY gain per patient. The intervention has an Incremental Cost-Effectiveness Ratio (ICER) of Rs. 1,05,100, which makes it cost-effective at a 1X GDP per capita (Rs. 1,98,464 in 2023) threshold [Table 2].

Globally, the prevalence of HCV among patients on HD has declined in the last two decades.⁴ A DOPPS study of facilities from Europe, the USA, and Japan showed a >50% decline in HCV prevalence and incidence between 1996 and 2015 due to a decline in blood transfusions, better screening strategies, and focused infection control practices, treatment of HCV-positive patients.⁵ KDIGO recommends that dialyzers be re,used among hepatitis C-positive patients, provided separate rooms are used for reprocessing dialyzers with hepatitis C machines.⁶

In our network, we reported HCV prevalence of 16% among 206 patients in 2012 and 8% among 3068 patients in 2014 using the HCV IgG ELISA testing method.⁶ We allocate dedicated dialysis machines for HCV patients within an isolated location. This practice was shown to have a seroconversion rate of 2.75% compared to 36.2% among historical controls in a tertiary care centre.^S1 The other challenges for controlling HCV transmission in India include poor awareness and practice of universal precautions among health care workers, lack of access, unaffordability of HCV RNA testing, and access to direct antiviral therapy. India has a National Hepatitis C program launched in 2018 with an ambitious target to eradicate HCV by 2030. It lacks a coherent strategy to address the disease burden among patients on HD.^S2

This study demonstrates that screening, treatment, and the use of dedicated dialyzers are cost-effective strategies at a 1X GDP threshold compared to no intervention in India and should be evaluated for further use.

HCV IgG, the dominant screening test method, has a high rate of false positivity in India’s public health system. HCV RNA testing and anti-viral treatment are an effective strategy to address the disease burden in the short term. There are multiple benefits, such as individual morbidity benefits and fitness for transplant, less infection risk, less cost due to less use of dialyzers, and improved access for Hepatitis C negative patients.