Note: People who are interested in the development of sofosbuvir by public and private money, the acquisition of sosbuvir by Gilead, and how keeping stockholders happy are the future of drug development in America should listen to the podcast by clicking on the link below – Alan
Victor Roy and Lawrence King argue that the acquisition strategies of drug companies magnify development costs and leave the public paying twice—for research and high priced medicines
Sofosbuvir based medicines have marked an important breakthrough for patients with hepatitis C infection, offering cure rates of over 90%. The virus is a leading infectious killer globally, disproportionately affecting vulnerable groups such as people who inject drugs or have HIV/AIDS.1 Even after discounts offered from a US list price of about $90 000 (£70 000; €80 000) per three month treatment course, however, the cost of these drugs, manufactured by Gilead Sciences, has challenged government budgets and led to rationing. Sofosbuvir’s pricing has been at the centre of a global debate over the affordability of prevailing systems of drug development, and the US Senate conducted an 18 month investigation into Gilead’s pricing strategy and its consequences for health budgets and patient access.2
One argument for the high prices has been that the curative drugs represent a major advance in value to patients and health systems. They are indeed more cost effective than many expensive medicines that provide only marginal benefit. Yet the company’s ability to charge high prices ultimately relies on monopoly protections via patents, which the industry has long argued are necessary to encourage costly research and development. Critics, however, charge that these costs are exaggerated.345
Jeffrey thought the battles in his life were over. But following his service in Iraq as a combat soldier, Jeffrey fought drug addiction and was later diagnosed with HIV. The next blow came when he learned that he was infected with the Hepatitis C virus (HCV), a blood-borne virus that can cause chronic liver disease, serious liver damage, and liver failure.
Jeffrey joined Amida Care — New York’s largest Medicaid special needs health plan for people living with chronic health conditions such as HIV/AIDS — and was able to take control of his health through holistic care. Through Amida Care, Jeffrey was also able to access groundbreaking treatment that cured him of HCV in just 12 weeks.
Not everyone has this opportunity, however — the high price of HCV medication keeps it out of reach for many. July 28 is World Hepatitis Day, which brings awareness to the goal of eliminating viral hepatitis as a public health threat by the year 2030. Without increased access to treatment, this goal cannot be achieved, and the health of those living with HCV or who are co-infected with HIV and HCV will remain at risk.
New Delhi, July 27 (IANS) Despite the cost of drugs coming down and dramatic advances in the treatment of Hepatitis B and Hepatitis C, getting rid of both types of the disease remains a huge challenge primarily due to lack of awareness and unsafe injection practices, experts have rued.
Hepatitis B is 50-100 times more infectious than HIV and Hepatitis C is 10 times more infectious than the virus that can cause AIDS. Yet, while people are by and large aware of HIV, there is little awareness about Hepatitis, health experts have lamented.
“In India, Hepatitis is a matter of concern because three to six billion injections are given each year, of which two-thirds are unsafely administered. This makes a large part of the population vulnerable to viruses transmitted through the blood,” Siddharth Srivastava, Associate Professor, GB Pant Hospital here told IANS.
According to the WHO, China has about 90 million chronic hepatitis B (HBV) sufferers. Of those, 28 million require treatment while seven million need urgent treatment because of advanced liver disease and the heightened risk of developing cancer. Another 10 million live with chronic hepatitis C (HCV), with 2.5 million in urgent need of treatment.
An HCV vaccine is urgently needed to prevent re-infection in people treated through antiviral therapies and reverse the high global mortality rates from infection-related liver cirrhosis or liver cancer, estimated by the World Health Organization (WHO) to be more than 500,000 people each year. More than 130 million people globally are carriers of HCV, a blood-borne virus.
The innovative hepatitis C vaccine project will combine Burnets’ proprietary HepSeeVaxDelta3™ technology, developed by Associate Professor Heidi Drummer and colleagues, with ARTES’ proprietary METAVAX®technology for the development of chimeric virus-like particle (VLP) based vaccines. The project aims to develop a VLP based vaccine that efficiently presents HCV antigens to prevent hepatitis C infection. The VLPs will present the novel, modified envelope protein (E2) on its surface, thereby targeting the vaccine to dendritic cells to prime and prepare the immune system to fight against hepatitis C infection.
Deputy Head of Burnet’s Centre for Biomedical Research and HCV vaccine team leader, Associate Professor Drummer said HepSeeVaxDelta3™ technology overcomes a critical limitation to HCV vaccine development. “The virus that causes HCV has evolved to avoid the immune system so that in natural infection, key immune responses are delayed or distracted by irrelevant targets on the virus. The same is true for conventional vaccine platforms tested previously. The HepSeeVaxDelta3™ component of the vaccine redirects the immune response to make antibodies on the most important targets that prevent infection against the seven circulating HCV genotypes.”
Two inmates in state prisons, with the help of the ACLU of Tennessee, have sued the state Department of Correction over lack of access to treatment for Hepatitis C. A press release noting the lawsuit states:
“Tennessee’s prisons must operate in compliance with the Constitution,” said Thomas H. Castelli, ACLU-TN legal director. “Incarcerating people under conditions that erode their health, safety and human dignity amounts to cruel and unusual punishment, which not only has devastating long-term effects for those individuals, but which undermines the purported purpose of a rehabilitative criminal justice system.”
The lawsuit was filed on behalf of an inmate at the Northwest Correctional Complex in Tiptonville and an inmate at the Hardeman County Correctional Facility in Whiteville, who were both diagnosed with HCV years ago while incarcerated at Tennessee Department of Corrections facilities. The complaint alleges that the Department of Corrections consistently and systematically denied the plaintiffs treatment for their disease in violation of the U.S. Constitution’s protection against cruel and unusual punishment.
In India, it is estimated that up to 1.5% of the population has a hepatitis C infection, with certain areas in the Punjab, North East and tribal areas considered possible “hepatitis C virus hotspots”. With a global burden of130–150 million people, hepatitis C, along with hepatitis B, is among the leading causes of liver cancer and pose a significant health challenge.
The standard of care for hepatitis C has changed over the years. Initially, it was only injectable interferon. Later, combinations of injectable interferon or pegylated interferon with ribavirin and protease inhibitors were introduced. More recently, the World Health Organization has recommended that newer oral agents called direct antiviral agents (DAA) be included for all patients with hepatitis C. DAAs have been found to be better tolerated, safer, need to be taken for shorter time and are more effective.
Dr. Samir Shah, Head, Department of Hepatology, Institute of Liver Diseases, HPB Surgery and Transplant, Global Hospitals, Mumbai recently presented the results from a 14-centre study across India where sofosbuvir was used in an interferon-free combination with ribavirin, for 117 treatment-naïve patients with chronic hepatitis C infections. “We found that this regimen was more effective in our Indian patients than the reports from the West,” he said.