June 23, 2014
Upcoming Hepatitis C Treatment Trial Sparks Quality Versus Cost Debate
redOrbit Staff & Wire Reports - Your Universe Online
A new combination therapy could cut treatment time for hepatitis C to just four weeks, but quicker recovery comes with a steep price, as the new medication is said to cost roughly $1,000 per pill.
According to Reuters reporter Bill Berkrot, the treatment involves an experimental antiviral drug produced by Bristol-Myers Squibb and Sovaldi, a drug produced by Gilead Sciences Inc. that has reportedly outraged insurance companies and health care officials with its price tag of $84,000 for a 12-week supply.
Despite the cost, the two pharmaceutical companies have announced plans to launch an exploratory 30-patient trial testing the combination medicine, the details of which are expected to be posted on the clinicaltrials.gov website sometime this week, Berkrot said. The treatment could cut hepatitis C recovery time to just four weeks.
The Associated Press (AP) explained that Sovaldi can cure the viral liver disease in 90 percent of patients, and that both patients and prominent health organizations are eagerly anticipating the drug, despite the cost. But the $1,000-per-pill treatment has raised a debate over what should be considered a fair price for a person’s health.
“The cost of this breakthrough drug is highlighting cracks in the US health care system at a time of heightened budget concerns. The Obama administration has a huge political stake in controlling treatment costs, but its critics may cry rationing,” the wire service said. “For insurers, there's a frustrating twist: For each middle-aged person they pay to cure with Sovaldi, any financial benefits from preventing liver failure are likely to accrue to Medicare, not to them.”
The AP reports that approximately three million Americans currently have the hepatitis C virus, though many of them are unaware. The disease can be transmitted through contact with infected blood and, in some cases, through sexual intercourse. Different types of the virus require different treatments, and as the conditions progresses, it can ultimately cause liver failure and require transplants costing more than half a million dollars on average.
From one perspective, Sovaldi and the new combination treatment cost a fraction of a liver transplant, though that has not stopped insurers from attempting to convince other drug companies from offering their hepatitis C medications at more affordable prices once they hit the market, according to Reuters.
“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,” Berkrot said. “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.”
These next-generation hepatitis C treatments may be pricey, but they have drastically improved cure rates, according to reports. Berkrot explained that interferon or ribavirin, drugs known to cause terrible side effects, cured approximately three out of every four cases. The new oral drugs cured more than nine out of every 10 hepatitis C patients, while also reducing treatment time from 24 to 48 weeks to just 12 weeks.
“Bristol's plan essentially revives an effort to test its drugs in combination with Sovaldi,” the Reuters reporter noted. “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.”
“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,” he added. “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.”