In the race to find a faster cure for Hepatitis C (HVC), Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc's blockbuster drug Sovaldi, hoping to cut treatment time to four weeks.
Bristol-Myers disclosed plans for the exploratory 30-patient trial testing of its three-drug combination with Sovaldi in an interview with Reuters. Eric Hughes, the leader of Bristol's global Hepatitis programme, said the details were due to be posted on the clinicaltrials.gov website next week.
Sovaldi's $84,000 price tag for a 12-week treatment has spurred outrage among insurers, state health officials and lawmakers who fear the cost of treating millions of Americans with the progressive liver disease will top $250 billion. Insurers are pushing Gilead's rivals to offer lower prices when their Hepatitis C medicines reach the market.
Using the drug for a shorter course of treatment could, in theory, lower the cost, even when combined with Bristol's therapies. Rivals Merck & Co and AbbVie are also racing to develop next-generation Hepatitis C treatments that cure most people of the virus in a shorter time frame.
But drug pricing experts expect Gilead and its rivals may still argue that the quicker cure represents a value to patients, buffering any steep price reductions.
"The position and concept of pharma is not ingredient costs or duration of treatment cost. Pharma is looking at it as cost per cure," said John Whang, co-president of Reimbursement Intelligence, which works with pharmaceutical companies and payers to help determine prices for medicines.
The cost could come down, he said, "but it's not going to be proportionate to the degree that the duration of treatment shortens."
The new generation of oral drugs being developed by several companies has raised Hepatitis C cure rates to well above 90 percent from about 75 percent without the need for Interferon or Ribavirin, which caused serious side effects that led many patients to delay or drop treatment. The drugs in clinical trials have already cut treatment times to 12 weeks from 24 to 48 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," Bristol-Myers' Hughes said in a telephone interview.
Reviving a Solvaldi combo
Bristol's plan essentially revives an effort to test its drugs in combination with Sovaldi. It previously tested a single compound with Sovaldi, achieving cure rates close to 100 percent in 12 weeks. But Gilead scrapped further testing in 2012, as it preferred to develop its own combination without a partner.
Gilead's pill that combines Sovaldi with its Ledipasvir is expected to gain US approval this year for therapies of eight or 12 weeks, depending on the patient. The company is also testing the combination as a six-week treatment.
The go-it-alone strategy has already paid off as Gilead was first to market with Sovaldi, breaking pharmaceutical industry sales records with $2.3 billion in sales within a few months.
The new study, set to begin in late July, will test a trio of Bristol drugs with Sovaldi in previously untreated patients with the most common Genotype 1 form of the virus. It will involve two groups of 15 patients each: one getting four weeks of treatment and the other six.
If Bristol can demonstrate cure rates in excess of 90 percent in four weeks, it plans to conduct larger trials with a more diverse patient population.
"We'll see what the data says," Hughes said. "Taking this forward will be a very exciting thing."
With Gilead not involved in the effort, Bristol will pay full price for Sovaldi to conduct the trial.
Bristol would not discuss potential pricing of its regimen, since its drugs are not approved. But if treatment can be cut to four weeks from 12, the Sovaldi portion would be closer to $28,000.
Other rivals are also advancing efforts to compete in what is expected to be a huge market.
The situation in Egypt
Egypt has the lion's share of Hepatitis C infections worldwide, spiking from four percent in 1993 to 8.5 percent in 2005. The total estimated number of Egyptians infected is currently around 12 million.
The probable cause of the spike in infection rates in Egypt was the use of contaminated needles in a campaign to eradicate schistosomiasis in the 1970s.
Of the six genotype strains of the virus, the fourth — previously treated with two combined drugs: Interferon, which targets the immune system, and Ribavirin — comprises the majority of infections in Egypt (90 percent)
The number of HVC infected reached eight million in 2008, according to the Ministry of Health registry of that year, translating into nearly 10 percent of the population, while in some Upper Egypt and Delta areas the percentage is a staggering 20 percent.
In 2011, two new drugs — Tela Previr and Boceprevir — were introduced in Egypt, but they were not suitable for the fourth genotype of Hepatitis C from which 90 percent of Egyptian patients suffer, causing negative side effects and drug interactions.
At the end of March, the pharmaceutical company producing the new Hepatitis C pill Sofospuvir announced it would offer Egyptians its new treatment at a 99 percent discount on the US price.
HCV is the leading cause of liver cancer, which is responsible for one third of the total number of cancer-related deaths worldwide.
Health experts in Egypt stressed that combining three oral medications — the new drug Sofosbuvir with Interferon and Ribavirin — had been proven to raise the cure rate for the genotype 4 HCV to 96 percent.
The combination of the three drugs halves the duration of treatment from six to three months, minimises side effects, and thus lowers costs overall.