Urging pharmaceutical giants Gilead and Bristol-Myers Squibb (BMS) to put patients' lives ahead of profits, the HCV Coalition for The Cure on February 19 will launch a White House petition drive seeking 100,000 signatures within a month to bring to President Obama's attention an exceptionally promising treatment for a deadly disease being held captive by corporate self-interest.
A combination of Gilead's drug sofosbuvir and BMS's daclatasvir in 2012 was found in Phase II trials to achieve a 100 percent cure rate for three of the most common types of liver-destroying hepatitis C (HCV), the most widespread blood borne infection in the United States. The combination treatment cured HCV type 1 within 12 weeks, and also showed the same promising results with types 2 and 3.
The all-oral combination would represent a great advance in HCV treatment, not only because of its remarkable results but because its side-effects--mild to moderate fatigue, headache and nausea--were well-tolerated. It would represent a vast improvement over the traditional chemo-style HCV treatment of interferon and ribavirin, both of which have severe and debilitating side-effects and achieve only about a 40 percent cure rate.
"We had never, ever imagined--even in our wildest dreams--we could treat hepatitis C so quickly, effectively and without serious side effects," said Paul Thuluvath, a physician at Mercy Medical Center in Baltimore, Md., who had six patients on the new treatment. "I think the pharmaceutical companies have a moral responsibility to work together and bring it to market instead of [following] their own vested interests."
Gilead withdrew from collaboration with its competitor, pulling its drug from the studies. Dr. Douglas J. Manion, a BMS senior Vice President, said his company is "keen" to work with Gilead, "but thus far, they have been unwilling to engage in that collaboration."
Instead of collaborating to further research the proven cure, each company instead has tried unsuccessfully to replicate the other's drug.
The HCV Coalition's White House petition follows an earlier petition at change.org that was signed by more than 11,000 people. The group also has joined its voice with other consumer advocate organizations, including the Los Angeles-based AIDS Healthcare Foundation, which has long been critical of the pharmaceutical industry.
"The unfettered greed that drives the lack of cooperation between pharmaceutical giants Gilead and Bristol-Myers Squibb comes at the unacceptably high price of the health and well-being of hepatitis C patients," said AHF president Michael Weinstein. "The withholding of effective treatment for patients suffering from this illness to instead boost shareholder returns has gone on for too long. This travesty must end."
About 3.2 million people in the U.S. have HCV. It is the number one reason for liver transplants, kills more people than AIDS, and 70 to 85 percent of those infected with the virus become chronic carriers--at heightened risk for cirrhosis and liver cancer and capable of transmitting the virus to others. According to the Centers for Disease Control and Prevention, HCV is most commonly and efficiently transmitted through exposure to infected blood, such as through transfusion of blood from unscreened donors, injected drugs. Although less common, it can also be transmitted sexually.
Margaret Dudley, a 61-year-old mother and grandmother in San Antonio, TX contracted HCV from having a cosmetic tattoo. Her efforts to research treatment options led her to found the HCV Coalition for The Cure along with her husband Gary Dudley (SWBC) after her September 2011 diagnosis.
Together with Craig Quirolo, one of the HCV patients cured with the Gilead-BMS drug combination, the HCV Coalition for The Cure has launched its White House petition drive. Said Quirolo, "President Obama could offer incentives to the drug companies which would encourage them to end this standoff and move forward to save lives."
Dudley added, "Although it feels like a David vs. Goliath battle trying to get Gilead to reconsider its position and collaborate with BMS, I have now become an advocate for this cause. I want to bring the nation's attention to this dire situation."