Pharmaceutical Giants Race to Develop Next-Gen Hepatitis Cure

In the hunt for a more efficient hepatitis cure, Bristol-Myers Squibb Co plans to test its own experimental antiviral drug combination with Gilead Sciences Inc’s groundbreaking Solvaldi. Their goal is to cut the full course of treatment down to four weeks.

The pharmaceutical company has unveiled its plans for a 30 person hepatitis C clinical trial which will test the three-drug combo (including Sovaldi). The head of Bristol’s global hepatitis program, Eric Hughes, announced that the details would be posted online at the end of the month.

The True Cost of Curing Hepatitis C

Health insurer’s have been more than a little shaken by the $84,000 price tag attached to Sovaldi. Many officials fear that the cost of treating more than a million HCV positive Americans with this effective new drug could exceed $250 billion. These insurers are now putting pressure on other pharmaceutical companies to develop their own versions and offer them at a lower price.

In theory, a shorter course of treatment might be able to lower the cost even when combined with existing therapies. Other giants like AbbVie and Merck & Co are competing to develop the next generation of hepatitis drugs that could cure patients in just four weeks.

Some expect Gilead and its competitors to argue that the steep costs are there for a good reason, especially considering the money being saved in the long run. Looking at the cost of a liver transplant, $84,000 seems more doable.

“The position and concept of pharma is not ingredient costs or duration of treatment cost. Pharma is looking at it as cost per cure,” explains John Whang, co-president of Reimbursement Intelligence, an agency that works with Big Pharma and payers to determine the most reasonable cost for medicines.

“The cost could come down,” says Whang, “but it’s not going to be proportionate to the degree that the duration of treatment shortens.”

Tackling the Next Great Challenge for Hepatitis Patients

Since Solvaldi was developed, the cure rates for hepatitis C have gone from 75 percent to well above 90 percent. Patients no longer require interferon or ribavirin, which means that there are a lot less side effects to contend with. The average course of treatment could run as long as 48 weeks before. They have now cut that to 12 weeks.

“We got rid of the tolerability problem. We got rid of the efficacy problem. Now there is a tremendous drive to get down to shorter treatment durations,” explained Hughes.

This is not Bristol’s first attempt to shorten this treatment time by combining a drug compound with Sovaldi. They tested a single compound that produced close to 100 percent cure rates in the 12 week period. However, Gilead chose to end the partnership so that it could continue developing its own unique combination.

Gilead’s oral drug (combining ledipasvir with Sovaldi) is supposed to gain FDA approval later this year. The expected course of treatment could take as little as 8 weeks depending on the patient. Their researchers are currently testing the combination’s effectiveness as a 6 week course of treatment.

Bristol Takes Steps to Shorten HCV Treatment Schedule

The new hepatitis C clinical trial is expected to commence next month. Accepted participants will have been diagnosed with the most common Genotype 1 form of HCV. There will be two groups in the study: one will be treated in four weeks and the other in six weeks. If the trial produces above 90 percent cure rates in the four week group, Bristol plans on moving on to larger clinical trials immediately.

Bristol will be paying the full price to use Sovaldi for this clinical trial. If they’re successful in their efforts, the price for Sovaldi portion will be dropped to $28,000. With more rivals developing their own unique combinations, the market for these next generation hepatitis C treatments could be huge.