Pahuli in Bijnor district has emerged as a hotspot of hepatitis C infection and dozens of patients wait for a treatment policy to get costly drugs
In January 2016, 40-year-old Wardhan (name changed) was rushed to a private hospital near Pahuli village in Bijnor, Uttar Pradesh, to treat a ruptured appendix. While preparing him for surgery, doctors found him positive for the Hepatitis C virus (HCV), an infection that causes chronic liver disease.
The doctors advised him to get his family members tested, a desirable practice when a patient tests positive for HCV. Within a week, seven out of 10 adults in Wardhan’s family tested positive.
Hepatitis C affects the liver, and has the same mode of transmission as HIV, spreading through blood, injecting drugs, blood transfusion, sexual activity and from mother-to-child during pregnancy. Although data on HCV is weak, the central government estimates that about 1.2 crore people are positive for Hepatitis C in the country — six times the number of HIV/AIDS patients.
There is no vaccine against the disease, and while it is curable, the Indian government is yet to announce the much-awaited Hepatitis C policy to advance treatment.
When this reporter visited Pahuli, tracking a community of some 200 families that are at the centre of a Hepatitis C hotspot in Uttar Pradesh, Wardhan’s emerged as one of the first families that were ‘out-of-closet’. He was diagnosed on January 10, 2016.
“Within days, my brother, father, uncle, wife cousins in extended family… every one was positive. We were so scared. Treatment seemed impossible, the entire family was affected, and our neighbours knew,” he says.
As Wardhan’s family tried to cope, Girdhari, his immediate neighbour, decided to get tested. “I was positive too,” he recalls.
On August 4, 2016, an unsettling mass diagnosis emerged, prompting Girdhari and a few men from Pahuli to visit Chief Medical Officer (CMO) Sukhbir Singh, since retired.
They informed the officials that most families had identical symptoms — bleeding easily and with wounds that did not easily clot, swelling in the legs and serious weight loss. Based on this, between 70% and 80% of families seemed to to be HCV positive. The same month, 100 samples from the village were collected in three batches and sent for testing. The results confirmed the villagers’ fears: 73 out of the 100 samples were positive. But the government did not give them the results.
“When they saw an overwhelming number, they refused to give us our medical records. No one has visited the village since August 2016,” says Girdhari.
The Hindu found that, as reports of HCV prevalence from rural India grew, the Health Ministry collected epidemiological data from villages like Pahuli. In March 2016, 5,00,000 samples were collected from HIV sentinel surveillance sites. While the study was completed in December 2016, no data has been published in the public domain.
Dr. R.R. Gangakhedkar, Head, Division of Epidemiology and Communicable Diseases at the Indian Council for Medical Research (ICMR) said, “Now that the programme [national policy] has been approved, the data is being analysed thoroughly. The data should become available in the next few weeks according to NACO. Since the analysis is in the final phase, we are unable to have access to the findings.” Queries on the decision to not publish the epidemiological data sent to the Health Ministry and the National Centre for Disease Control (NCDC), the implementation agency for the HCV policy, were not answered.
Lack of transparency
Public health experts maintain that lack of transparency in sharing epidemiological data could lead to spread of the disease. “Medical ethics dictate that data collected from a community must be transparently available to those people. Governments have to trust the community to stop the spread of the disease. In the two years that the hepatitis data was kept a secret, more people in that community donated blood, engaged in high risk behaviour and spread the disease,” said Dr. Amit Sengupta, convener of the India chapter of People’s Health Movement.
The World Health Organisation said in a statement that it had not received the full findings, even though it had funded the study. “The complete findings have not been shared with WHO, neither in a meeting nor in a report. We understand that the report is being finalised by the government and we are looking forward to the results of the study,” a WHO representative said in a written statement to The Hindu.
A senior official in the Health Ministry said on condition of anonymity: “The numbers were so much more than what we expected. It was felt that the study’s findings could not be made public without a solution. So, we quickly moved to finalise the National Hepatitis Policy.”
The ICMR said the data was not put in the public domain as “it took a while to finalise the contours of the national program.”
On the hepatitis policy, Union Health Minister J.P. Nadda announced on July 28, 2017, that the government would come up with a National Action Plan by December 2017 and roll it out by April 2018.
The absence of reliable data is affecting the push for wider treatment access. The ‘largest study’ on HCV in India was done between 2008 and 2014 with 777 patients. The study, published in 2015 at the National Centre for Biotechnology Information (NCBI) under the U.S. National Library of Medicine noted that, “data on prevalence of HCV infection in India is scanty and the only sources are a few screening studies done on blood donors and pregnant women, and a few community-based studies.” Based on available data, WHO estimates that approximately 12 million Indians suffer from HCV, compared to the prevalence in the US of 2–4 million and in Europe of 5–10 million.
For those like Wardhan who are positive, the treatment currently available is unsound. After the diagnosis in Pahuli, when government officials disappeared, medical representatives made an appearance, said Niri Devi, another patient. The people are left with two options: go to the village quack or jholachaap, who can manage only smaller ailments or take remedies offered by pharmaceutical companies.
Medical representatives (MR) come to the village on a referral system. Families like Wardhan’s, which can pay, pass on the contacts of these representatives to newly-diagnosed patients. Ajay John, a representative who visits the village every three weeks says, “Almost every day I get a call from a patient.” I refer them to a doctor in Bijnor or Meerut, who writes them a prescription for Sofosbuvir, a drug that has revolutionised treatment for HCV.
On March 23, 2018, the Ministry of Chemicals and Fertilizers said in Parliament that six pharmaceutical companies had applied for price approval of Sofosbuvir 400 mg and Velpatasvir – 100 mg tablets and simultaneously launched their formulation without prior price approval from the National Pharmaceutical Pricing Authority (NPPA).
The NPPA had fixed the retail price of Sofosbuvir tablets at ₹ 15,625 (excluding GST) for a course, or an MRP of ₹17500 for the six companies. Of these, five companies had launched their formulation at an MRP of ₹18500 for 28 tablets. NPPA issued show cause notices to all the five and three had deposited the overcharged amount along with interest.