An 8-week treatment course of ledipasvir/sofosbuvir (LDV/SOF) for genotype 1 hepatitis C virus (HCV) infection is associated with high rates of sustained virologic response at 12 weeks (SVR12) and is noninferior to the 12-week regimen, according to a study published in Hepatology.
The US Food and Drug Administration recommends considering an 8-week regimen of LDV/SOF in patients with HCV genotype 1 infection who are treatment naive, do not have cirrhosis, and have a viral level less than 6 million IU/mL.1 Although the 8-week course may help reduce treatment costs compared with the standard 12-week regimen, this recommendation is based on a post hoc analysis of the ION-3 trial, which has significant limitations and also conflicts with some real-world outcomes data.2,3
Vinay Sundaram, MD, from Cedars-Sinai Medical Center, Los Angeles, California, and colleagues evaluated the real-world effectiveness of an 8-week regimen of LDV/SOF in patients with HCV genotype 1 infection who were treatment naive and did not have cirrhosis. The authors also performed a meta-analysis to determine whether the treatment duration of 8 weeks is noninferior to 12 weeks.1
A total of 634 patients from 3 real-world cohorts were included in this study. Of these, 583 had viral load less than 6 million IU/mL and were considered eligible for treatment with the 8-week regimen.1
The SVR12 was 98.1% for the overall cohort and 97.9% for treatment-eligible patients.1
The SVR12 rates were at least 97% in all subgroups except among African Americans (95.9% for overall cohort, 95.8% for treatment-eligible patients) and patients with stage 3 fibrosis (94.1% for overall cohort, 93.9% for treatment-eligible patients).1
In the meta-analysis of real-world data, 6 studies were included, which encompassed 5637 patient cases. SVR12 rates were similar between patients treated with 8 weeks and those treated with 12 weeks of LDV/SOF (95.8% vs 97.2%). The 8-week course was found to be noninferior to the 12-week regimen.1
“In patients who meet the criteria for 8 weeks of treatment, this regimen is highly effective and should be utilized to lead to long-term savings to the healthcare system and increase access to care for hepatitis C treatment,” Dr Sundaram said in an interview with Infectious Disease Advisor.
However, Dr Sundaram cautioned that this recommendation may not apply to all patients who are eligible for 8 weeks of treatment: “Although 8 weeks of treatment with LDV/SOF was effective across all patient groups, the majority of relapsers were African American and had stage 3 fibrosis. It is still unknown as to whether patients with both of these characteristics should get 12 weeks of treatment instead of 8 weeks,” he said.
Disclosure: Dr Sundaram and several study authors report financial relationships with Gilead and other pharmaceutical companies.
Kowdley KV, Sundaram V, Jeon CY, et al. Eight weeks of ledipasvir/sofosbuvir is effective for selected patients with genotype 1 hepatitis C virus infection [published online December 27, 2016]. Hepatology. doi: 10.1002/hep.29005
Kowdley KV, Gordon SC, Reddy KR, et al; ION-3 Investigators. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879-1888. doi: 10.1056/NEJMoa1402355
O’Brien TR, Feld JJ, Kottilil S, Pfeiffer RM. No scientific basis to restrict 8 weeks of treatment with ledipasvir/sofosbuvir to patients with hepatitis C virus RNA <6,000,000 IU/mL. Hepatology. 2016;63:28-30. doi: 10.1002/hep.28292