Eight weeks of ledipasvir/sofosbuvir (LDV/SOF) should be considered in patients with genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, do not have cirrhosis, and have a pretreatment viral load below 6,000,000 IU/mL, a study found, using patient data from real-world cohorts.
Researchers used individual patient data from three databases, one in Germany and two in the U.S. All patients had fibrosis staging assessed with biopsy, transient elastography, or serum biomarkers.
In the pooled data analysis, 634 patients were treated for eight weeks with LDV/SOF. The mean patient age was 56.1 years. Patients were mostly white (60.1%), but with equal proportion of men and women. The majority of patients had a pretreatment HCV viral load below 6,000,000 IU/mL (91.9%). About twice as many patients had genotype 1a (64.4%) as genotype 1b (31.9%). Patients were mainly fibrosis stage 0-2 (81.4%), with 18.6% of patients having stage 3 fibrosis. A small percentage of patients (2.5%) also had HIV infection.
The primary outcome was SVR12, defined as plasma HCV RNA level below quantitation or undetectable at least 12 weeks after completing treatment. For patients who did not achieve this, outcomes were reported as a per protocol analysis, either as relapse or as virologic breakthrough. Results were published online Feb. 25 by Hepatology.
Per protocol rates of sustained virologic response at 12 weeks were 98.1% (622 of 634 patients) in the full study cohort and 97.9% (571 of 583 patients) among those eligible for treatment per FDA recommendations. A meta-analysis of six additional real-world cohorts composed of 5,637 patients demonstrated similar risk for relapse between eight weeks and 12 weeks of LDV/SOF (relative risk,0.99; 95% CI, 0.98 to 1.00).
In addition, an eight-week course of therapy would cost $63,000 at wholesale prices, compared to $94,500 for a 12-week course. SVR12 rates approached 94% or greater among all subgroups, and no specific baseline characteristic was associated with greater risk of relapse. (Among seven patients with a relapse and with stage 3 fibrosis, five were African American, leading the authors to conclude that a 12-week regimen may be preferable in this population.)
“We propose incorporation of the 8-week treatment course into current treatment guidelines to increase use of this regimen, thereby leading to cost savings and increased patient access to treatment,” the authors wrote.