Clinical setbacks integral to long-term success in HCV treatment

In a new report, the Pharmaceutical Research and Manufacturers of America examined the successes and failures of hepatitis C virus infection research and therapies since the infection was discovered 25 years ago.

“Hepatitis C research successes have built over time,” the report said. “Following the identification of the virus in 1989, stepwise improvements in interferon-based therapy ensued over the next two decades…After years of research and many setbacks, the first of these medicines — direct-acting antivirals — were approved in 2011. Since that time, many more of these medicines have been approved and researchers are finding even greater success in employing a combination of antiviral therapies to more effectively combat the disease.”

According to the report, 77 investigational medicines have failed in clinical trials between 1998 and 2014. However, the “failures” led to approval of 12 other medicines during the same period, creating a new era for the treatment of HCV.

“The medicines that are now transforming treatment for hepatitis C patients are the result of decades of scientific challenges and setbacks,” the report said.

HCV was once thought to be incurable, but through the tireless work of public health officials to prevent and screen at-risk populations for HCV and researchers developing new safe and effective treatments, cure rates have risen from 6% to 52% and continue to rise over 90% at present day, according to the report.

In 1991, the FDA approved interferon, the first treatment for HCV then in 1998 the first interferon and ribavirin combination treatment for HCV genotype 1-infected patients was approved. In 2001, a pegylated form of interferon was approved for use in combination with ribavirin. Since 2011, direct-acting antivirals, including simeprevir (Olysio, Janssen Therapeutics) and sofosbuvir (Sovaldi, Gilead Sciences) and different combinations have been approved, including the first interferon-free treatment regimen — sofosbuvir/ledipasvir (Harvoni, Gilead) for HCV genotype 1-infected patients, which was granted FDA approval in October.

“New and forthcoming hepatitis C treatments represent a remarkable advance against a very serious disease,” John J. Castellani, chief executive officer of PhRMA, said in a press release. “These treatments are often curing more than 90% of patients — transforming lives and helping to avert billions of dollars in unnecessary hospitalizations and other costly medical services. Forthcoming treatments are projected to provide even greater cure rates and shorter duration of treatment, vastly improving patients’ health and quality of life.”

There are currently 75 medicines in the US in clinical development for HCV, according to the report. Researchers are studying ways to treat HCV across all genotypes, especially genotype 3, which is a difficult-to-treat strand of the infection.

“These [new] medicines promise to improve cure rates further, reduce side effects and duration of treatment and expand treatment options,” the report said. “The future is truly hopeful for patients with hepatitis C.”