Trial involving experimental medications shows six-week cure rate.
The drugs included a combination of sofosbuvir and ledipasvir and one of two experimental drugs by Gilead Sciences, GS-9669 and GS-9451.
Sixty participants were assigned into three groups; 20 patients were allocated to sofosbuvir and ledipasvir for 12 weeks; 20 patients to sofosbuvir, ledipasvir, and GS-9669 for 6 weeks; and 20 patients to sofosbuvir, ledipasvir, and GS-9451 for 6 weeks. None of the participants had developed cirrhosis, or scarring of the liver, which occurs in the later stages of the blood-borne disease.
Of the patients treated with one of the experimental drugs, 38 out of 40 were cured of the disease. In the group receiving GS-9669, only one volunteer relapsed after the six-week regimen. All were deemed cured in the branch that received GS-9451, except for one patient who was lost to follow-up after reaching sustained viral response at four weeks.
Dr. Shyam Kottilil, formerly of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) teamed up with other researchers from the NIH Clinical Center and National Cancer Institute.
“We wanted to see how far we could push the limit, and what’s the minimum duration you need to cure hepatitis C,” Kottilil said in an interview with Healthline. “Six weeks was considered to be unachievable.”
Shorter treatment durations will improve chances to eliminate hepatitis C worldwide, the authors noted in the study. “This short duration, simple therapy for HCV may prove relevant for the global elimination of hepatitis C, where simple, well-tolerated therapy of short duration is required to ensure adherence.”
One obstacle to shorter treatments is cost. Harvoni (ledipasvir-sofosbuvir), the most recently approved rapid cure medication, costs around $95,000. The high price tag for this daily pill taken for 12 weeks poses challenges to public health insurers such as state Medicaid programs. Debates are raging surrounding who should have access to the medications and when.
The approval of Harvoni revolutionized hepatitis C treatment after another drug, Sovaldi (sofosbuvir), had done so just months before. Both drugs offer cure rates upwards of 90 percent, but Sovaldi is used with ribavirin, an older-class hepatitis C treatment. Harvoni’s 12-week cure rate and the elimination of the need to use interferon offered hope to millions. For years, combination treatments of ribavirin and interferon put patients through brutal, lengthy treatments that weren’t always successful.
A 12-week course of Sovaldi costs $84,000. Other new drugs have also come to the market, like Johnson and Johnson’s Olysio (simeprevir), which can be used in combination with other primary treatments.
AbbVie brought VieKira Pak (ombitasvir/paritaprevir/ritonavir with dasabuvir) to market. VieKira offers around a 95 percent cure rate in 12 weeks. Also, the medications are packaged in a way to encourage easy adherence. The pharmaceutical has integrated other features into its treatment to help patients stay on track. The cost is the same as Sovaldi but it doesn’t require the use of ribavirin.
Days after receiving FDA approval, Express Scripts announced it had a struck a deal with AbbVie to make VieKira Pak the exclusive treatment for hepatitis C patients. In a press release, Express Scripts says it has expanded access to the drug by making it more affordable to insurers. Gilead countered by announcing it had struck a deal with CVS Health. In addition, Reuters reported that Gilead had worked out agreements with three other insurers.
It’s a glimmer of a so-called price war that hepatitis C advocates had been hoping for, but it’s not an ideal one, Dr. David Bernstein told Healthline.
“I personally don’t like the deals that are being made, because as a physician, it takes away my choice,” said Bernstein, chief of hepatology at the Center for Liver Disease at North Shore-LIJ Health System and a fellow at the American College of Gastroenterology.
Some patients may be better off with one regimen than the other, he added. “This isn’t a proton pump inhibitor,” referring to the myriad heartburn medications that have flooded the market and are used interchangeably. “There are subtleties to the use of these different (hepatitis C) medications. I still think physician choice is relevant.”
But he said when the end result is getting treatment to the people who need it, it’s a step in the right direction.
“The tolerability of the new therapies is tremendous. The biggest challenge right now is getting through all the hurdles of prior authorizations to get the medications. It’s extremely frustrating.”
Bernstein said the small trial showing the effectiveness of a six-week course of treatment looks promising, but that it needs to be replicated in larger clinical studies.