## After a Long Struggle…Forever Grateful 

Too many times, it looked like Nisha Gupta’s battle against hepatitis C would end badly. The Detroit-area rheumatologist first contracted the chronic infection in May 1990 when, as a medical resident, she drew blood from an infected patient. Although she wore gloves, the needle pricked her skin. Soon she experienced her first symptoms and eventually was diagnosed with hepatitis C. 

Dr. Gupta received treatments on and off ever since, first to slow the infection’s advance and then mostly to control symptoms like severe itching, fatigue and mental confusion. “I worked until September 2009, when I found out I had liver cancer,” Gupta recalls. “By then I was prepared to die.” 

By her first liver transplant, she was suffering from hepatic encephalopathy, a worsening of brain function when the liver is no longer able to remove toxic substances in the blood. Her remissions after two liver transplants were short-lived, but her family and physician never lost hope. Her hepatologist tried to obtain compounds then in clini - cal development from two manufacturers under the FDA’s 

multiple myeloma cells, but minimally expressed on normal tissue. It is believed that this mechanism allows the immune system to selectively kill myeloma cells with minimal effects on other cell types. It has shown promise in mid-stage trials. 

Pipeline sustainability ultimately depends on other parts of our approach to R&D, including a strategy of creating backups for compounds in development, expertise in key biologic targets and a “follow the science” philosophy in clinical development 

Nisha Gupta,M.D. 

compassionate use program, where physicians can apply for early access to experimental compounds for individual patients who have no effective therapeutic alternative. Concerned about drug interactions with their compounds, the companies rejected the applications. 

Then the FDA suggested a third experimental therapy from Bristol-Myers Squibb. Its investigational compound was daclatasvir, currently in Phase III trials and not yet approved. Bristol-Myers Squibb said yes, and daclatasvir was given alongside two standard therapies. 

Eric Hughes, M.D., Ph.D., had just arrived at Bristol- Myers Squibb back in 2010. Among his responsibilities was coordinating virology compassionate use inquiries. “Given Dr. Gupta’s dire straits, we believed the risk/ben - efit profile of providing early access to daclatasvir was acceptable,” he says. 

Today, Dr. Gupta is virus free and offers “a very special thanks to Bristol-Myers Squibb and its compassionate employees. They gave hope back to me and my family.” 

that better characterizes both benefit and risk and is willing – and able – to challenge the current standards of care for the benefit of patients. r 

