NEW ORLEANS, LA—Adding ribavirin to the directly-acting antiviral agent (DAA) regimens paritaprevir/ritonavir/ombitasvir and dasabuvir (PrOD), sofosbuvir/simeprevir (SOF+SIM), and sofosbuvir/ledipasvir (SOF+LDV) does not affect these regimens’ high sustained virologic response (SVR) rates in real-world clinical settings among patients with hepatitis C virus (HCV) infection, according to research presented at IDWeek 2016.
“PrOD, SOF+SIM, and SOF+LDV regimens are associated with high rates of SVR in actual clinical settings, which are comparable to clinical trial results,” reported lead study author Adeel Butt, MD, MS, of Weill Cornell Medical College in New York, NY, and the VA Pittsburgh Healthcare System in Pittsburgh, PA.
“Confounding due to indication is a limitation of this study,” Dr. Butt cautioned.
With DAA regimens, HCV SVR rates have exceeded 90%.
It is unknown whether or not adding ribavirin improves SVR rates in real-world clinical practice. Nevertheless, ribavirin is a “key component of several HCV treatment regimens, particularly those with advanced liver fibrosis [and] cirrhosis,” and is frequently added to DAAs “even when not indicated by labeling guidelines,” Dr. Butt noted.
To better understand ribavirin’s role in combination with DAA regimens, Dr. Butt and his team set out to determine the SVR rates of these regimens in patients HCV infection. Using the U.S. Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES) national cohort, they identified patients with HCV genotype 1 infections initiated on the three regimens. (Patients with HIV co-infection, a positive HBsAg, or missing HCV RNA were excluded from the analysis.)
A total of 1,235 patients on PrOD (932 of whom were also administered ribavirin); 1,254 patients on SOF+SIM (212 with ribavirin); and 4,247 patients on SOF+LDV (990 ribavirin) were identified from the cohort.
“No meaningful difference in SVR rates was observed in those prescribed or not prescribed ribavirin with SOF+SIM, SOF+LDV or PrOD (for genotype 1b),” Dr. Butt reported.
SVR rates ranged from 92% to 100%, regardless of the treatment regimen.