Published: Nov 5, 2013
Coverage of Hepatitis C Virus is supported in part by an independent educational grant from AbbVie Pharmaceuticals.
By Michael Smith, North American Correspondent, MedPage Today
Reviewed by F. Perry Wilson, MD, MSCE; Instructor of Medicine, Perelman School of Medicine at the University of Pennsylvania
WASHINGTON -- Hepatitis C (HCV) patients with mental comorbidities, such as depression or bipolar disorder, can be successfully treated with an interferon-free drug regimen, a phase II trial showed.
The combination of ribavirin and the investigational agent sofosbuvir was equally effective in patients with and without significant mental health disorders, according to Amy Nelson, RN, of the National Institute of Allergy and Infectious Diseases in Bethesda, Md.
Importantly, both groups of patients were equally likely to adhere to the medication and to appear for study visits, she told MedPage Today at the annual meeting of the American Association for the Study of Liver Diseases.
The finding is important because it opens the door to effective therapy for people with mental illnesses, for whom standard therapy has been contraindicated, Nelson said.
The standard treatment for HCV for several years has been based on a combination of ribavirin and pegylated interferon, but the latter drug has psychiatric side effects that make it unsuitable for many patients who already have mental illness, she explained.
"A lot of people haven't been treated" because of that issue, Nelson said, adding that the finding gives "a lot of hope as we move away from interferon ... that [the] whole group that hasn't been treated can clear the virus."
Sofosbuvir is one of several so-called direct-acting agents in the development pipeline -- drugs that target parts of the HCV genome rather than boosting the immune system, as interferon does -- and is one of the most advanced in the regulatory process.
An FDA advisory panel has recommended it be approved for use in combination with ribavirin for patients with genotypes 2 and 3 of HCV. In those with genotypes 1 and 4, the panel recommended using it with interferon and ribavirin. The agency is not obliged to follow the advice of its committees, but usually does.
In the SPARE study, Nelson and colleagues treated 60 HCV patients, all with genotype 1 disease, for 24 weeks with daily sofosbuvir (at 400 mg) and either low-dose or weight-based ribavirin.
Of those, 23 had an active mental health disorder, defined as requiring pharmacotherapy for major depression, bipolar disorder, schizophrenia, anxiety, or depression with anxiety.
Nelson and colleagues found that patients with mental health disorders attended 97% of required study visits, compared with 98% by the remaining participants.
Also, among those that finished the 24 weeks of treatment, 83% of both groups missed fewer than four doses of sofosbuvir.
And 61% of those with a mental health disorder had undetectable virus 12 weeks after the end of therapy, compared with 68% of those in the rest of the cohort. The difference was not significant.
The prevalence of mental health issues among HCV patients is "quite high," commented Michael Fried, MD, of the University of North Carolina Chapel Hill, who was not part of the study.
"So there is a very high rate of patients who, when they first come to see you, have poorly controlled mental health issues and they are not candidates for antiviral therapy that is peginterferon based," he told MedPage Today.
But the study by Nelson and colleagues shows that those patients are "quite a treatable population" if doctors have interferon-free regimens available.
He noted that, if sofosbuvir is approved, the indication for genotype 1 patients will include interferon and ribavirin.
But other combinations of drugs under clinical investigation -- including the pairing of sofosbuvir and ledipasvir, which blocks the action of the viral nonstructural protein 5A -- can be used without interferon to treat genotype 1 patients.
The study was supported by the National Institute of Allergy and Infectious Diseases.
Nelson reported no conflicts of interest. Two co-authors were employees of Gilead.
Fried reported financial links with Gilead, Vertex, Bristol-Myers Squibb, Merck, Genentech, Janssen, and Abbott.
Primary source: American Association for the Study of Liver Diseases
Source reference: Nelson A, et al "Impact of pre-existing mental health disorders on adherence and sustained virologic response with an interferon-free trial of sofosbuvir and ribavirin for chronic Hepatitis C" AASLD 2013; Abstract 319.