October 8, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
Sovaldi, a new hepatitis C drug from Gilead Sciences, Inc. , may now be too expensive to fund. This news came on Oct. 7 when data showed that the National Health Service would need to spend approximately 1 billion pounds, or more than $1 billion, each year.
This report is casting a shadow on further development of Sovaldi, despite the fact that the National Institute for Health and Care Excellence has stated that it is willing to pay for the treatment. The drug is thought to be one of the most expensive treatments in the world, outside of oncology.
In addition to funding Sovaldi, investors would need to take Copegus into consideration. The drug, which is also known as ribavirin, is necessary for a full course of treatment in some patients.
Sovaldi received approval from the U.S. Food and Drug Administration back in 2013 for the treatment of hepatitis C infection. Clinical data showed that Sovaldi, also known as sofosbuvir, could cure the disease in 90 percent of patients after 12 weeks of treatment.
Sovaldi is a nucleotide analog inhibitor that blocks a specific protein that the hepatitis C virus needs to replicate. Depending on the type of hepatitis C infection that a patient has, ribavirin may need to be used in combination with Sovaldi regularly to see positive results.
Initially, Sovaldi’s effectiveness was evaluated in six clinical trials that involved more than 1,900 patients. These individuals had not received treatment for the disease or showed responsiveness to treatment methods that were previously administered. The trials were all analyzed to determine if the infection could be detected in the blood at least 12 weeks after beginning Sovaldi.
Sovaldi was proven to help patients with multiple types of hepatitis C infection. It was also effective in patients who could not tolerate interferon-based treatment, or those who were awaiting a liver transplant. The most common side effects cited by study participants were fatigue, nausea and insomnia.
Following the studies, Sovaldi received breakthrough therapy designation from the FDA. This designation is typically given to certain drugs or therapies to expedite the approval process. However, the cost associated with producing Sovaldi now presents a new complication to medical professionals looking for viable options for hepatitis C patients.
