In a comparison of clinical trial results for Gilead Sciences Inc.’s Harvoni (ledipasvir/sofosbuvir) versus the results from studies conducted in real-world settings, eight weeks of treatment proved just as effective as a 12-week regimen.

The Food and Drug Administration approved Harvoni in October 2014 for patients with chronic hepatitis C (HCV) genotype 1. The approved indications included eight, 12 or 24 weeks of treatment based on patient criteria, with the shortest regimen recommended only for patients with no previous treatment, no cirrhosis and a baseline viral load of less than 6 million IU/mL. 

According to Dr. Nora Terrault, a hepatologist with the University of California, San Francisco, most clinicians prescribe 12 or 24 weeks of treatment for patients who meet the eight-week criteria, even though the shorter regimen is considerably less costly and requires fewer patient visits. Terrault believes this prescribing pattern stems from concerns that the clinical trial results might not carry over into real-world practice.

To see if there was any basis for such concerns, Terrault and her colleagues compared the results from a clinical trial used to support the original FDA approval, ION-3, versus the findings from five real-world studies: HCV-TARGET, TRIO, VA-Ohio, GECCO and Buggisch. She recently presented their findings at the International Conference on Viral Hepatitis. 

Overall, in the five studies that assessed Harvoni in real-world practice settings, 620 patients who underwent eight weeks of treatment had an SVR12 (a sustained virologic response 12 weeks after completing therapy) of 97 percent or higher, indicating undetectable HCV. 

In November, the FDA expanded its approval of the 12-week Harvoni regimen to include patients with HCV genotypes 4, 5 and 6, as well as patients who also have HIV. It also approved the 12-week regimen in combination with ribavirin as an alternative to the 24-week regimen for patients with HCV genotype 1 and cirrhosis who have already been treated for HCV. 

Last month, the FDA further expanded the approved indications for the longer regimens, but the original criteria for the eight-week regimen have not changed.

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