LAHORE: The president of Pakistan has asked the Ministry of National Health Services, Regulations & Coordination, Islamabad, to register an ‘affordable’ medicine of hepatitis C in oral form to facilitate hundreds of thousands of patients awaiting low-priced drugs.

The development came after a pharmaceutical company, Everest Pharma, offered surprisingly low price for the hepatitis oral drug – Rs398 per tablet –which is many times cheaper than the one registered by the Drug Regulatory Authority Pakistan (Rs1,900 per tablet) in November 2014.

The company has also submitted a clinical trial report on its drug for hepatitis C drug, sofosbuvir (Sovir), after senior doctors recommended it for registration by DRAP.

The President’s Secretariat asked the ministry to provide cheaper hepatitis C medicine through a letter addressed on June 19 last. It also gave a reference of a poor woman of Khanewal who, in an appeal to the president, had sought his intervention for provision of low-priced hepatitis C oral drug. She was suffering from chronic hepatitis C disease and was unable to buy the drug from the market due to its high cost.

In a related development, the prime minister has suggested to the Everest Pharma to provide medicine Sovir to at least 100 patients free of cost. The Punjab chief minister through a letter of June 17 had asked the chief executive of the company to ensure implementation on the prime minister’s suggestion.

An official told Dawn that millions of hepatitis C patients in Pakistan were unable to get the medicine since DRAP had granted registration to only one pharmaceutical company. As there was no competitor in the market, the price of the Sovaldi (in tablet form) remained higher even compared to the interferon (in injection form), he said.

The DRAP Pakistan had granted rights to the Ferozsons Laboratories in November 2014 to make available a pack of 28 tablets for Rs55,000. The official said though the company had later reduced the price to Rs33,000 per pack of 28 tablets, the cost was still beyond reach of millions of poor hepatitis C patients.

He said some other pharmaceutical companies had also applied for the registration of this drug to create a healthy competition in order to make the hepatitis C medicine more reachable. Though many companies’ price offers against the drug were enormously high, one of them – Everest Pharmaceuticals - had given the lowest price, Rs398 only, for a tablet. It was hundreds time less than that fixed by DRAP while registering it in favour of Ferozsons Laboratory, he said.

Normally, duration period of treatment course of the disease has been six weeks. Consequently, a patient had to bear total expense of Rs198,000 for Sovaldi drug for a complete course, while the Everest company offered the same at Rs66,000. The company later also indicated to further reduce it to Rs57,000 in the interest of the patients.

The offers submitted to DRAP by other companies for granting registration to their respective medicines included M/s W-group Pharmaceuticals Rs87,000 per tablet, ACTO Laboratories Rs2,500, Tabros Pharma Rs8,200, Mecter Pharma Rs8,000 and Getz Pharma had offered Rs5,000 per tablet.

Though many of these companies had apprised DRAP that they were ready to negotiate price of the drug in the light of financial status of the patients, the Authority shelved cases of all of them instead of considering their proposal.

The Everest Pharma, which had offered the lowest price, was also awaiting registration of the drug by DRAP despite the fact that senior doctors who had conducted clinical trial of the drug declared it safe for use in treating hepatitis C patients.

The clinical trial of Sofosbuvir drug was completed by former chairman of Shaikh Zayed Hospital, Lahore, Prof Dr Zafar Iqbal, and Gujranwala Medical College Principal Prof Dr Aftab Mohsin.

“This medicine has proven efficacy and tolerability in the patients of chronic hepatitis C and it will be useful addition to armamentarium against hepatitis C,” Prof Mohsin declared in its recommendations formulated after the clinical trial.

He further wrote that on approval of the Institutional Review Board of GMC, Sofosbuvir (Sovir) 400mg along with Ribavirin dosage calculated according to the weight of patient was prescribed to 20 cases of chronic liver disease who were either ineligible to receive interferon or were interferon non-responders. Ten such patients have completed four-week therapy and all have achieved RVR according to real time PCR technology, he claimed.

Prof Zafar declared that in all the cases the drug was well tolerated in week one and week two of follow up.

Highlighting significance of the cheaper oral drug, he stated that Pakistan was recognised as one of the countries in the world with the highest prevalence of hepatitis C virus. In the Middle East and the Asia Pacific region, Pakistan stands second after Egypt.

“The prevalence of HCV in Pakistan is at least eight per cent, with much higher figures for certain population pockets,” Prof Zafar said, adding that this translates into an estimated 12 million infected people, of which four million could have serious liver disease and one million might be at greater risk of developing liver disease.

Published in Dawn, July 5th, 2015

On a mobile phone? Get the Dawn Mobile App: Apple Store | Google Play