Dr Gagandeep Singh Grover State Programme Officer, IDSP/HCV Punjab Negotiating affordable access to diagnostics and medicines in Punjab for HCV Dr Gagandeep Singh Grover State Programme Officer, IDSP/HCV Punjab

Has population of 29 mn appx 22 districts with wide variations Northern State in India. Has population of 29 mn appx 22 districts with wide variations

Problem of HCV-Punjab Exact magnitude was not known Prevalent Genotype Certain studies had highlighted PSACS (NACO) data was indicative Prevalent Genotype Exact was not known PGI data was the most relevant and authentic Risk factors Known but not able to pinpoint due to lack of evidence

Urban%- 3.09 Rural%- 3.38 Total%-3.29 HCV Prevalence in Surveyed Districts 0.63 0.39 0.46 Urban%- 3.09 Rural%- 3.38 Total%-3.29 3.15 0.28 2.05 0.00 3.82 1.79 0.00 0.64 0.5 0.0 4.11 0.2 2.16 1.11 0.00 8.86 12.45 3.26 5.83 2.83 5.73 4.84 13.64 2.95 5.22 High Prevalence

District Wise Seropositivity of Hepatitis C; As per Data of Punjab State AIDS Control Society (PSACS) National average <1.0% PSACS Data 2015 (Dec)

District Wise Seropositivity of Hepatitis C; As per Data of Punjab State AIDS Control Society (PSACS) PSACS Data 2015 (Dec)

Steps by Govt of Punjab

Rate Contract for HCV Testing and Treatment Drawbacks $ 46 for one inj $ 1150 for 24 weeks $ 2300 for 48 weeks Price was still high for some groups No mechanism of track and record of the patients No mechanism of standardized follow up Govt. Of Punjab did tenders for injectable drugs (Interferons) in 2014-15 Drugs supplied by the pharmaceutical company Inj. available at Jan Aushadhi Stores Available to the patients at subsidized rates per injection

Dr RK Dhiman, Prof. Hepatology, PGIMER

Mukh Mantri Punjab Hepatitis-C Relief Fund (MMPHCRF) A State Initiative: a public health programme for Hepatitis-C Launched in June 2016, offers free treatment of Hepatits C to all residents of Punjab Funds approved by the Government of Punjab for the Hepatitis-C relief fund Decentralized Hepatitis C treatment 22 District Hospitals and 3 Government Medical Colleges

Principles of MMPHCRF STANDARDIZATION EQUALITY AVAILABILITY Testing and Treatment has been standardized Regimens (fixed) have been designed EQUALITY Drugs to be provided free of cost to all Regardless of religion, ethnicity & economic condition AVAILABILITY In Govt Hospitals at 3 Govt medical Colleges and 22 District Hospitals in first phase AFFORDABILITY

Sensitization of Medical & Paramedical Personnel Medical and Paramedical personnel involved in examining, diagnosing and providing treatment have been sensitized Regimens, Follow ups and Testing Co morbid conditions Special circumstances

Sensitization before Launch of MMPHCRF 80 Medical Specialists in 3 batches 50 Pharmacists in 2 batches 25 SMOs and Nodal Officers 22 Distt Epidemiologists 25 DEOs

Algorithm for Treatment of Hepatitis C in Punjab HCV RNA (+) Cirrhosis* Absent Present§ Genotype-Optional¶ Genotype-Mandatory Sofo+Dacla for 12 wks** Genotype 1 & 4 Genotype 3 Sofo+Ledipasvir+Riba for 12 wks$ Sofo+Dacla+Riba for 24 wks HCV RNA for ETR (Optional) HCV RNA for SVR (Mandatory) MMPHCRF 2016 Dr RK Dhiman

Rate Contract for Testing Tenders for baseline and follow up testing (Viral Load and Genotype) Baseline testing standardized Anti HCV-ELISA: Free in 25 centres CBC Free in 25 centres LFT Free in 25 centres RFT Free in 25 centres USG

Rate Contract for Testing RC with Dr Lal Path Lab Rates fixed for Viral Load and Genotype tests $ 31 for viral load (quantitative) $ 43 for genotype (for cirrhotics) SVR test is free under MMPHCRF 160 collection centres in State

Recommended Regimens with Treatment Durations for Patients without Cirrhosis Genotype Regimen 1 [Sofosbuvir/ Ledipasvir] Regimen 2 [Sofosbuvir/ Ledipasvir/ Ribavirin] Regimen 3 [Sofosbuvir/ Daclatasvir] Regimen 4 [Sofosbuvir/ Daclatasvir/ Ribavirin] Genotype 1 12 weeks No Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 MMPHCRF 2016 Dr RK Dhiman

Recommended Regimens with Treatment Durations for Patients with Cirrhosis Genotype Regimen 1 [Sofosbuvir/ Ledipasvir] Regimen 2 [Sofosbuvir/ Ledipasvir/ Ribavirin] Regimen 3 [Sofosbuvir/ Daclatasvir] Regimen 4 [Sofosbuvir/ Daclatasvir/ Ribavirin] Genotype 1 24 weeks 12 weeks Genotype 2 No Genotype 3 Genotype 4 Genotype 5 Genotype 6 MMPHCRF 2016 Dr RK Dhiman

Rate Contract for Drugs (DAAs) Standardized procurement PHSC procurement agency RC done twice Storage at 3 Drug Ware Houses District HQ Regimen Drugs For 12 weeks (1st tender) (2nd tender) Regimen 1 Sof + Ledi $ 306 $ 191 Regimen 2 Sof + Ledi + Riba $ 331 $ 215 Regimen 3 Sof + Dacla $ 267 $ 105 Regimen 4 Sof + Dacla + Riba $ 280 $ 128

Comparison of Rates of DAAs Drug MRP ($) Market Price ($) Punjab Govt Rates ($) Sof+ Ledi 357 143 64 Dacla 100 13 Sofo 260 157 22 Riba 129 71 8 Prices for one bottle of 28 caps Except Riba where one bottle is of 140 cap

Follow up and Tracking of patients Treatment Cards for patients availing MMPHCRF Personal details Medical details Regimens and Follow ups Master Data with UID for each case Follow up of case Centralized case record ETR (End of Treatment): Not recommended SVR (Sustained Viral Response) records: 12 weeks after ETR

Monitoring & Evaluation

MMPHCRF Patient Cascade (18.6.16 to 06.04.2017)

Case Load – Centre wise

Prevalent Genotypes

Rural/ Urban

Age wise Distribution (%)

Cirrhotic/Non Cirrhotic

SVR outcome

SVR Certificate

Awareness Campaigns

Collaborations

CHAI MoU with CHAI M&E tool for HCV cases under MMPHCRF M&E tool enabling: Demographic profile of the patients Prevalence of various genotypes in different areas Hot Spots (as per the cases recruited under MMPHCRF) List of patients due for follow up Any patient LFU (Lost to Follow Up) Expected ETR and SVR dates

M&E - CHAI Analysis GIS mapping for hotspot identification Enrollment Outcome LFU - tracking GIS mapping for hotspot identification

ECHO

ECHO for HCV in Punjab Node: PGIMER Chandigarh Spokes Deptt of Hepatology State Deptt of Health Spokes 3 GMCs 22 DHs

ECHO Sessions

Taking small Steps towards Strengthening of surveillance with aim of Provision of quality diagnostics & drugs with vision of HCV Elimination in Punjab