Drug registration delay affecting hepatitis patients

LAHORE: The Drug Regulatory Authority (DRA) has delayed registration of a ‘miracle’ drug which is meant to treat chronic patients of hepatitis C. Approved by the US Food and Drug Administration (FDA), ‘sofosbuvir’ (brand name Sovaldi) is considered by many as a revolutionary treatment for hepatitis C and is said to effectively cure hepatitis in 90pc of the patients in combination with other therapies. The drug was discovered by an American biotechnology company as an alternative to the injection-based interferon therapy which has been a rather painful mode of treatment with risks of multiple side-effects. Gilead Sciences, a US company, claimed a breakthrough by discovering life-saving interferon-free oral drug last year. It is now available in the international market in the form of a 400mg pill. The delay in approval of the drug has raised questions about the DRA mechanisms and processes. A senior official told Dawn that many leading pharmaceutical companies across the globe had declared sofosbuvir a “blockbuster drug”. He said it had no side-effects compared to interferon which caused high temperature, flu-like symptoms, anaemia, depression, hair fall, etc. The cure rate of interferon available in the market is 45pc. “The sofosbuvir is a direct-acting antiviral for hepatitis C, results in significantly higher cure rates in a shorter period of time than current injection-based therapy, and for all genotypes of hepatitis C, eliminates the need to use pegylated interferon, which is difficult to administer and causes multiple side-effects,” the official said while quoting a recent study. He said that after successful launch of the drug in the US market, the world was fast moving to the oral mode of hepatitis C treatment from the old ‘injectable’ one. “Only one tablet of 400mg daily is advised for hepatitis,” he said. At present, the recommended treatment is pegylated interferon alpha (in combination with ribavirin). “It is a direct-acting antiviral (DAA) administered orally which has also reduced treatment time from 24-48 weeks to 12 weeks without side-effects,” says the research study. Gilead, claimed the official, had introduced the drug in the developing and middle-income countries on discounted rates. He said one pill of Sovaldi is being sold in America for $1,000. The official said the drug had been registered for patients in the US, Europe, Africa, Latin America, Gulf, India and China. He said three pharmaceutical companies had applied for registration of this drug in the DRA. “M/s W-group Pharmaceuticals is the first such firm, which had offered price per pill of Sofosbuvir of Rs87,000 in October 2013. If this is approved, the total cost of treatment may reach Rs7.31 million for genotypes 1, 2 and 4 while total cost of therapy for genotype 3 will be Rs14.62 million. “Similarly, M/s Ferozsons Pharmaceuticals Nowshera offered in May a price of Rs2,000 per tablet and the total cost of treatment would be Rs168,000 for genotypes 1, 2 and 4 for complete course while the total cost of therapy for genotype 3 was estimated to be Rs336,000. “M/s Everest Pharmaceuticals Islamabad offered lowest price of Rs398 per tablet. Its therapy for treatment of genotypes 1, 2 and 4 would cost Rs33,432 and for treatment of genotype 3 Rs66,864.” The official claimed that chairman of the Central Drug Registration Board had the authority to register any drug without any meeting of the board. There was precedence and several drugs were registered without board meeting keeping in view the urgency to save lives. DRA Central Registration Board chairman Ghulam Rasool Duttani told Dawn that the new oral drug was in the first phase of evaluation. He said the case would be forwarded for registration after clearance by the evaluation cell of the DRA. Later, it would be recommended for pricing, Mr Duttani said, adding that the process of approval of the drug would take time. Answering a question, he confirmed that the DRA had received applications from three pharmaceutical firms for registration and pricing of the new drug. Two senior doctors, Prof Dr Anwar A. Khan and Prof Dr Ghias-un-Nabi Tayab, declared the drug as a ‘breaking news’ for the hundreds of thousands of patients in Pakistan who are infected with the virus. Dr Khan is a former chairman of the Shaikh Zayed Hospital, Lahore, while Prof Ghias is dean of the faculty of gastroenterology at the College of Physicians and Surgeons Pakistan and chief of the gastroenterology department of the Postgraduate Medical Institute/Lahore General Hospital. Both the doctors called for launching of the drug in Pakistan without any delay, in the interest of the patients. Published in Dawn, June 26th, 2014