A study led by a Johns Hopkins researcher has found new evidence that Sovaldi, a drug whose expensiveness has made it highly controversial, helps cure hepatitis C in people with HIV and has the potential to limit a top cause of death in those patients.
In a study of 223 HIV-infected patients, Gilead Sciences Inc.’s Sovaldi combined with ribavirin cleared the most common U.S. strain of hepatitis C in 76 percent of newly treated patients over 24 weeks. Only seven participants stopped treatment because of side effects and there were no adverse effects on HIV treatment, according to a report in the Journal of the American Medical Association.
Complications from hepatitis C are the leading cause of death for those with HIV, according to the research. In the past, treatment for 7 million patents co-infected with the viruses globally have been limited because older hepatitis C regimens that include interferon interact badly with HIV drugs, with more anemia, fatigue and depression, researchers said.
This is “the first clinical trial to demonstrate that we can cure hepatitis C in patients with HIV co-infection without the use of interferon,” said Mark Sulkowski, the study author and medical director of the Johns Hopkins Infectious Disease Center for Viral Hepatitis in Baltimore. “It represents a transformative step in our approach to this therapeutic area.”
The hepatitis C virus can lead to chronic liver disease, liver scarring and cancer, sometimes requiring a transplant.
“We can achieve excellent effects with co-infection in a manner we’ve achieved with mono-infections,” said Raymond Chung, a doctor at Massachusetts General Hospital who was not involved with this study. “Now that we’re in the effective conversion of HIV to a chronic disease, the new opportunist if you will is complications from hep-C.”
While these results represent a step forward, the cost of the course of treatment could be prohibitive for many patients, said Michael Saag, an AIDS researcher at the University of Alabama in Birmingham in an e-mail. He wrote an editorial accompanying the research about the challenges to access.
“The patients and providers who have to file countless forms, often multiple times, simply to obtain approval for the drugs and the payers, including many government systems around the world, are heavily burdened by the pricing,” Saag said in an e-mail. “I don’t think the new drugs at the current prices are affordable. It is a shame.”
Other drugs are also expected to become available for hepatitis C in the next six months and may drive those costs down, Chung said. AbbVie and Merck & Co. are among companies with drugs for hepatitis C in phase II trials, according to a Bloomberg Industries report. Olysio, a Johnson & Johnson hepatitis C pill, was cleared last November by the Food and Drug Administration. It isn’t recommended for patients with HIV, according to information on the FDA’s website.
Even with new drugs entering the market, Saag said he was skeptical about pharmaceutical companies dropping the price. The 12-week course of treatment would be $94,500 and the 24-week course $189,000, according to Saag’s editorial. The high cost of Sovaldi has come under scrutiny from U.S. lawmakers and U.K. regulators.
“The pricing of drugs is a good example of where a ‘free market’ might exist, but in my experience never does,” Saag said. “I’m not holding my breath.”
Michele Rest, a spokeswoman for Gilead, cited the “clear need for HVC treatment regimens that are more effective and safer” for those co-infected with HIV.’’
The drug combination was approved for use by HIV-positive people with types 2 and 3 hepatitis C virus by the U.S. Food and Drug Administration in December. For those with type 1, the recommended course of treatment includes interferon, which changes the immune system’s responses and can interact badly with HIV-controlling drugs, Chung said in a telephone interview.