One of the leading causes of death among HIV patients is hepatitis C, and a third of HIV patients in the U.S. are co-infected. Treating hepatitis C in conjunction with HIV has proven difficult, as previous treatments interact with the anti-retroviral HIV medications.
A clinical trial conducted by a team of researchers resulted in a cure of chronic hepatitis C in a significant majority of co-infected patients. The cure--a combination drug therapy--contains sofosbuvir and ribavirin and is administered orally.
The results of the trial were published in The Journal of the American Medical Association. A total of 223 co-infected patients were treated in the clinical trial. Patients that had never before received any treatments responded well, the majority of them successfully cured. The patients that had experienced treatment before responded even more successfully.
"The likelihood that a patient with chronic, long-standing hepatitis C infection would have spontaneous cure is near zero," says Mark Sulkowski, medical director of the Johns Hopkins Infectious Disease Center for Viral Hepatitis. "So if these patients had not been treated, none would have been cured."
The study, Sulkowski says, "represents the first clinical trial to demonstrate that we can cure hepatitis C in patients with HIV co-infection without the use of interferon." Interferon is a hepatitis C treatment administered via injections that often displays low efficacy and tolerability, sometimes reacting adversely with anti-retroviral HIV medications.
The trial is a step towards advancing hepatitis C therapy, especially as it is a leading cause of death among co-infected patients, of which there are 7 million known worldwide.
The study was funded by Gilead Sciences, the biopharmaceutical company that developed sofosbuvir, known commercially as Sovaldi. The company has been the center of a drama unfolding around the $84,000 price tag set forth for Sovaldi. Earlier this year lawmakers objected to the high cost, which amounts to $1,000 a pill, and requested an explanation from the company as to why it is necessary. The company plans on responding with a detailed outline of the needs for the high cost, and argues that Sovaldi has displayed more promising results for patients than any previous hepatitis C drug.
Hepatitis C is the inflammation of the liver caused by a blood-born virus. Recovery from the disease is rare. It is transmitted through infected blood, sexual contact, birth and contaminated, shared needles.
The results of the clinical trial are promising, but the authors of the study acknowledge the limitations of the methods and resources. As the trial was non-randomized, certain groups of people were underrepresented, such as women. Additionally, not many patients in the trial were in the advanced stages of HIV, compromising the integrity of the combination therapy's safety in more vulnerable patients. Lastly, the study did not use a control group and therefore the authors are limited in the conclusions they may draw.