Some of the most difficult hepatitis C cases to treat are patients who are co-infected with hepatitis C and HIV. Potential side effects, possible drug interactions with antiviral medications used to treat HIV, and an inability to physically tolerate the treatment are just a few of the reasons co-infected patients are unable to receive treatment for the hepatitis C portion of the infection, which can lead to death. The ALLY-2 phase III trial may have changed that. A combination drug therapy consisting of Bristol-Myers Squibb’s Daklinza (daclatasvir) and Gilead Sciences’ Sovaldi (sofosbuvir) was found to have cured 97 percent of hepatitis C infections in the HIV/HCV co-infected study participants.
What’s more, the HIV treatment did not have to be altered for the hepatitis C combo to be effective. Patients were given a daily regimen of the combination therapy over a 12 week period.
Gilead Sciences has also developed a separate drug for hepatitis C, Harvoni (ledipasvir and sofosbuvir), a daily single tablet treatment that resulted in a 96 percent cure rate of hepatitis C in co-infected patients participating in the phase III ION-4 trial.
Co-infection isn’t the only area of the hepatitis C battle seeing progress. Harvoni, as well as Gilead Sciences’ drug Sovaldi, has been shown to be effective in hepatitis C patients; but all of these medications, though effective, are expensive. The cost of a single Harvoni pill is $1,125, making access to the drug an impossibility for many, but costs have been going down.
Addressing the global nature of the hepatitis C epidemic, the Express Tribune reported today that the Pakistan federal government announced a price reduction on Sovaldi, cutting it by almost 40 percent, and promising that adequate amounts of the drug would quickly be made available. The World Health Organization estimates there are 180 million cases of hepatitis C worldwide.
But price cuts on the drugs are not exclusive to government bodies, according to Bloomberg News, Gilead Sciences will discount Harvoni and Sovaldi by an average of 46 percent. The discounts should make treatment more affordable and should affect policy change in the United States, to widen the scope of hepatitis C cases to which the new medications should be prescribed.
““What we’re recommending to our plan sponsors is that we treat everyone,” said Steve Miller, Chief Medical Officer at Express Scripts Holding Co., in an interview with Bloomberg News
Additional hepatitis C studies are planned for Harvoni. Unity Health Care, in partnership with Family and Medical Counseling Services, the National Institutes of Health, and the University of Maryland, recently announced that it will soon begin their ASCEND study in Washington, DC.
ASCEND will screen 600 hepatitis C patients in Washington, D.C., where Unity Healthcare hopes to discover the effectiveness of Harvoni in a community health setting versus that of the clinical studies that have already been conducted.
Hepatitis C is a viral infection that attacks the liver. Symptoms in early onset are nearly undetectable, but when left untreated, can lead to cirrhosis of the liver, liver cancer, and liver failure.