Introduction

Hepatitis C is a contagious liver disease that results from infection with the hepatitis C virus (HCV). Progression from acute to chronic HCV infection occurs in 50% to 85% of cases. Left untreated, the complications associated with chronic infection are severe. Chronic HCV infection may lead to cirrhosis and subsequently hepatic decompensation, hepatocellular carcinoma and death [1].

In India, the overall prevalence of HCV infection is 1.5% with the North and the North-Eastern parts of the country particularly affected [2-6]. Unsterile therapeutic injections and health care procedures, injection drug use and blood transfusions are the most common routes for HCV transmission [7,8]. Recognizing the need to address this disease, the Government of Haryana developed a first-of- its kind program to provide free Hepatitis C treatment for individuals belonging to Below Poverty Line (BPL) and Scheduled Caste (SC) categories.

In November 2013, the department of medical gastroenterology at Post Graduate Institute of Medical sciences (PGIMS) Rohtak was identified as the main treatment center in the State. Anti-hepatitis C virus antibody positive patients were referred for confirmatory testing and treatment in Rohtak at PGIMS.

Patient Enrollment

Patients who were found to be having anti-HCV positive, during evaluation at screening camps, blood donation camps, Pre-anesthetic checkup for various surgeries or incidental detection and subsequently confirmed on HCV RNA quantitative and genotyping were enrolled under this scheme. Every patient underwent detailed clinical examination as well as complete biochemical and ultra-sonogram abdomen testing. On average, 55 patients are enrolled in the program each month (Table 1).

Patients were required to submit documentation that verified their eligibility for program enrollment. Documents include BPL/ SC identification, a baseline HCV RNA report and written consent was taken from patients (Table 2).

Patient characteristics

Table 3 and 4 show the age and gender distribution of patients enrolled in the Program. The mean age of enrollees is 36 years; close to two-thirds (60%) are between the ages of 21-40 years. 58% of enrollees are men, while 42% are women.

HCV genotype is an important factor in determining treatment duration. Patients with Genotype 3 were treated for 24 weeks, while patients with Genotypes 1,4, 5, 6 were treated for 48 weeks. It has previously been established that Genotype 3 is most prevalent in India, followed by genotype 1 and then genotypes 2, 4, 5 and 6 [9]. In Haryana too, the majority of patients enrolled in the Program were found to have HCV Genotype 3 (58%), followed by Genotype 4 (25%). The genotype could not be determined for 56 patients (3.66%) because of low viral load (Table 5).

On-therapy Diagnostic Testing

During the course of treatment, the viral load of patients is tested at specific time points to assess responsiveness to therapy and likelihood of achieving a virological cure. a. After 4th week injection b. After 12th week injection c. End of Therapy (after 24th or 48th week injection) d. Sustained Virological Response (24 weeks after End of Therapy)

Table 6 shows the test status of all patients enrolled in the program. Table 7 shows that the Program received almost all diagnostic reports for patients who were provided on-therapy HCV RNA coupons. All reports were validated and uploaded to the online system (100%).

The viral load of positive patients is also entered into the online system to facilitate monitoring of treatment response. Table 7 shows that 90% of patients achieved a Rapid Virological Response; that is, their 4th week HCV RNA test was negative. Similarly, 92%, 91% and 90% of patients respectively achieved an Early Virological Response, End of Therapy stained virological response respectively. That is, the HCV RNA test for these patients was negative at 12 weeks, 24/ 48 weeks and after six months of completion of treatment respectively. On analysis of SVR in different genotypes, 91.5% was seen in Genotype 3, 87% in Genotype 4, 87.5% in genotype 1, 100% in patients with undetermined genotype due to low viral load and in six patients belonging to genotype 5 & 6. Thus making overall 90% SVR in the treated patients.

Patient Counseling

Counseling services significantly increased the likelihood that patients adhere to the prescribed therapy schedule. Program patients were counseled at enrollment on several topics including the disease and its symptoms, modes of transmission, treatment, length of treatment, diagnostic testing schedule, typical side effects and side effect management. Table 8 shows that all patients received counseling at the time of enrollment.

Therapy completion

The online system enabled the progress and adherence of patients to be tracked from enrollment to therapy completion. Based on the date when therapy was first initiated, the online system projected a weekly dosing schedule across the entire treatment period (24 or 48 weeks) for each patient. The therapy status of each patient was tracked on regular basis.

Therapy adherence

In order to be considered adherent, patients must follow their weekly schedule and complete therapy within the designated treatment period (Table 9).

Summary

Haryana is the first State in India to develop a comprehensive program to address Chronic Hepatitis C. 1530 patients from BPL/SC categories received free treatment for Chronic Hepatitis C and were enrolled in an integrated disease management program that provided counseling and on-therapy diagnostic testing. An online system was also developed to enable efficient capture and tracking of patient information. The Program has been successful on several fronts. Documentation of patient eligibility, provision of coupons for diagnostic testing, and report validation and upload were conducted in compliance with Program guidelines. Through counseling and monitoring, a high percentage of patients (93%) have adhered to their prescribed treatment regimen. Patient outcomes have also been extremely encouraging i.e. SVR of 90%.In India, the overall prevalence of HCV infection is1.5% with the North and the North-Eastern parts of the country particularly affected. The Jeevan Rekha project at Department of Medical Gastroenterology at PGIMS Rohtak can serve as a model for the rest of the Nation (Figure 1).

1. McHutchison JG, Bacon BR (2005) Chronic hepatitis C: an age wave of disease burden. Am J Manag Care 11(10 Suppl): S286-S295.
2. Lavanchy D (2011) Evolving epidemiology of Hepatitis C Virus. Clin Microbiol Infect 17(2): 107-115.
3. Sood A, Sarin SK, Midha M, Hissar S, Sood N, et al. (2012) Prevalence of hepatitis C virus in a selected geographical area. of northern India: a population based survey. Indian J Gastroenterology 31(5): 232-236.
4. Medhi S, Goswami B, Das A, Singh TB, Husain SA, et al. (2012) New insights into hepatitis C virus infection in the tribal-dominant part of Northeast India. Arch Virol 157(11): 2083-2093.
5. National Summary Report – India (2011) Integrated Behavioral and Biological Assessment (IBBA), Round 2 (2009-2010). New Delhi: Indian Council of Medical Research and FHI 360.
6. Chelleng PK, Borkakoty BJ, Chetia M, Das HK, Mahanta J (2008) Risk of Hepatitis C infection among injection drug users in Mizoram. Indian J Med Res 128(5): 640-646.
7. Mukhopadhya A (2008) Hepatitis C in India. J Biosci 33(4): 465-473.
8. Sievert W, Altraif I, Razavi HA, Abdo A, Ahmed EA, et al. (2011) A systematic review of hepatitis C virus epidemiology in Asia, Australia and Egypt. Liver Int 31(Suppl 2): 61-80.
9. Narahari S, Juwle A, Basak S, Saranaths D (2009) Prevalence and geographic distribution of Hepatitis C Virus genotypes in Indian patient cohort. Infect Genet Evol 9(4): 643-645.

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  Figure 1: Jeevan Rekha: Counter for Hepatitis C in Haryana.

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  Table 1: Summary of patient enrollment in Program.

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  Table 2: Documentation provided prior to program enrollment.

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  Table 3: Distribution of age among enrolled patients.NA=Not applicable

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  Table 4: Distribution of gender among enrolled patients.

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  Table 5: Distribution of genotype among enrolled patients.

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  Table 6: Provision of coupons for on-therapy HCV RNA testing.

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  Table 7: Diagnostic reports and results received.

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  Table 8: Patients provided counseling at enrollment.

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  Table 9: Adherence to therapy schedule.