Published: Nov 7, 2013
By Michael Smith, North American Correspondent, MedPage Today
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco
WASHINGTON -- A two-drug, single-pill regimen for hepatitis C (HCV) -- used with or without the standard medication ribavirin -- led to viral cures in 97% of patients, a researcher reported here.
The 100 patients all had genotype 1 HCV and included previously treated patients, some with cirrhosis, as well as treatment-naive people, according to Eric Lawitz, MD, of the University of Texas Health Science Center in San Antonio.
But after eight or 12 weeks of treatment, all but three remained free of the virus at the end of 12 weeks of follow-up, Lawitz said at the annual meeting of the American Association for the Study of Liver Diseases.
In the so-called LONESTAR study, Lawitz and colleagues are testing the single-pill combination of sofosbuvir, a nucleotide polymerase inhibitor, and ledipasvir, which blocks the nonstructural NS5A protein.
Action Points
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
A two-drug, single-pill (sofosbuvir and ledipasvir) regimen for hepatitis C (HCV) -- used with or without the standard medication ribavirin -- led to viral cures in 97% of patients.
Note that the patients in the study all had genotype 1 HCV and included previously treated patients, some with cirrhosis, as well as treatment-naive patients
Sofosbuvir remains investigational but has been recommended for approval, with different indications depending on HCV genotype. An FDA advisory panel suggested it be used with interferon and ribavirin in genotype 1 patients, but with ribavirin alone in genotypes 2 and 3.
Ledipasvir is not that far along in the regulatory process.
The rationale for LONESTAR, Lawitz said, is that HCV patients would benefit from short, simple, interferon-free regimens.
However, the "minimum treatment duration and optimal interferon-free regimen for genotype 1 patients is unknown," he said, and there is little data on all-oral regimens for genotype 1 patients with cirrhosis.
Also, he noted, there is no current effective treatment available for patients who have tried and failed the current standard of care -- pegylated interferon and ribavirin, combined with one of two approved protease inhibitors that target the virus itself -- telaprevir (Incivek) and boceprevir (Victrelis).
To help fill the gap, he and colleagues enrolled 60 genotype 1 patients and randomly assigned them to eight or 12 weeks of the single-pill combination alone or eight weeks of sofosbuvir/ledipasvir with ribavirin.
A second cohort of 40 genotype 1 patients, all with virologic failure after previous therapy and 55% with cirrhosis, were randomly assigned to 12 weeks of therapy with sofosbuvir/ledipasvir with or without ribavirin.
The primary endpoint of the study was undetectable virus 12 weeks after the end of therapy, or SVR12.
Among the treatment-naive patients, Lawitz reported, two patients, both treated with sofosbuvir/ledipasvir alone, were not cured -- one who relapsed after eight weeks of therapy and one lost to follow-up in the 12-week arm.
In the second cohort, one patient relapsed, a cirrhotic patient given sofosbuvir/ledipasvir alone.
In essence, the findings suggest that -- at least in patients like this -- the fixed-dose combination is likely to yield near-perfect results, Lawitz said.
"All the regimens produced a consistently high sustained viral response rates," he said, "irrespective of the patient being either treatment naive or a protease failure."
"The addition of ribavirin had no impact on outcome," he added, "and in protease failures, the results were independent of the presence or the absence of cirrhosis."
The regimens were well tolerated, Lawitz said.
The outcomes are "unbelievable," commented Michael Fried, MD, of the University of North Carolina Chapel Hill, who was not part of the study.
"When I first started, SVR rates were 7%," he told MedPage Today. "To see it move up to routinely over 90% and 95% is remarkable."
But he cautioned that -- as in all clinical trials -- patients were selected and monitored carefully.
"Real-world observational studies are going to be critical" to figure out the benefits and pitfalls of the new therapies, he said.
Fried is a principal investigator of HCV-Target, an international consortium of scientists that is doing just that -- conducting longitudinal observations on HCV therapy with the new direct-acting agents, although little data is available now.
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