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Early data shows promise in “real-world” effectiveness.
Twelve weeks of treatment with the direct-acting antiviral (DAA) all-oral combination of ledipasvir plus sofosbuvir for genotype 1 hepatitis C virus (HCV) infection shows “real-world” effectiveness, according to a new study.
Early data regarding the “real-world” experience with novel DAAs are encouraging, with sustained virologic response (SVR) rates of 93% to 96% after 8 to12 weeks of ledpasivir-sofosbuvir. These results mirror the SVR rates observed in clinical trials with the combination. However, until now, data were lacking on “real-world” results with treatment-experienced patients.
“Our study linked data from healthcare clinics to specialty pharmacies dispensing medication. This is highly characteristic of the cohort of patients seen in the community and in academic centers, with both women and men of different races. This diverse sample of patients reflects healthcare treatment, including those who had previously been treated for HCV,” Elliott Tapper, MD, assistant professor of medicine at University of Michigan, told Medical Economics.
The researchers published their results in the January 2017 Journal of Viral Hepatitis.
Tapper and colleagues conducted a retrospective cohort study of 1597 patients, age 60 years on average, with chronic genotype 1 HCV who were treated for 12 weeks with a regimen of ledpasivir-sofosbuvir without ribavirin (1521 patients) or with ribavirin (76 patients).
Next: The results
Overall, the two-drug combination resulted in a SVR rate of 94%; only 44 (2.9%) patients relapsed. With ribavirin, the therapy yielded a SVR rate of 97% with no viral relapses.
As expected, cirrhosis and thrombocytopenia were associated with lower odds of SVR. A multivariable analysis found only treatment at an academic center and prescriptions contrary to FDA labelling, which suggest adding ribavirin for patients with cirrhosis and treatment failure, were significantly associated with lower SVR.
“In patients who completed treatment, 94% experienced a cure. This is what we saw in clinical trials that controlled for the best outcome. These drugs are delivering on the promise from clinical trials in the real world,” said Tapper. “If clinicians follow the package labeling from the FDA, they will maximize the odds of obtaining a cure.”
Patients who are treatment-experienced should receive ribavirin, he said. “I see patients who have been treated in the community successfully. Others who are treatment failures may have advanced cirrhosis or were pretreated and may be sensitive to ledpasivir-sofosbuvir, but still have relapsed. Adding in ribavirin makes the drug more effective in these cases by enhancing the immune response to the virus,” said Tapper.
He noted there are some limitations to the study. “We can’t speak to special populations, such as patients on hemodialysis, or those who may be considering liver transplant with decompensated cirrhosis,” said Tapper. “Ours was a stable patient population. We can’t say why some patients did not receive FDA-recommended therapy. They may have had a negative experience with ribavirin previously, or had hemolytic anemia, which is contraindicated with ribavirin.”
Tapper added: “These drugs work. Few patients stop taking them. The treatment experience is generally benign. Even with a high cure rate, we still need to determine which patients are candidates for adding in ribavirin.”