A phase 4 prospective observational study revealed that the combination of Olysio plus Sovaldi is both commonly used by physicians and effective for treating patients with hepatitis C virus infection.
“The combination of [Olysio (simeprevir, Janssen Therapeutics)], a once daily NS3/4A protease inhibitor, and [Sovaldi (sofosbuvir, Gilead Sciences)], a once-daily NS5B polymerase inhibitor, with or without ribavirin, is approved in the U.S. for the treatment of genotype 1 HCV infection, based on the phase 2 COSMOS study,” Imtiaz Alam, MD, of the Austin Hepatitis Center, Austin, Texas, and colleagues wrote. “Data observed in routine practice can vary significantly from results obtained from clinical studies.”
To obtain “real-world data” on simeprevir regimens, Alam and colleagues enrolled 315 adults with chronic HCV infection from multiple treatment centers in the United States, analyzing the effectiveness of treatment with simeprevir as well as patient characteristics, practice settings, virologic response rates and safety outcomes from February 2014 through November 2015. The primary outcome was the proportion of patients who attained SVR.
In the intent-to-treat population, 275 patients completed the study, although 291 were treated with simeprevir plus sofosbuvir. Seventeen patients received simeprevir, sofosbuvir and ribavirin, while another seven received simeprevir, pegylated interferon and ribavirin.
Most (63.2%) patients were male and white (60.6%). Their median age was 58 years, and most patients had HCV genotype 1a infection (71.7%). More than one-third (39.4%) had cirrhosis.
Researchers reported that 81.2% (n = 255) of patients in the intent-to-treat population achieved SVR. In the modified intent-to-treat population, which disqualified patients who stopped treatment early for nonvirologic reasons, 92.4% of patients achieved SVR. Alam and colleagues wrote that higher virologic response rates were associated with age 65 years or older, employment status, and non-Hispanic or Latino ethnicity, but not with cirrhosis status or HCV genotype. The researchers wrote that there were no serious adverse events from simeprevir.
They noted that simeprevir had not been approved for use with sofosbuvir when the study first began, and that HCV treatment had made “tremendous progress” since 2014.
“[The study] demonstrated the effectiveness and safety of simeprevir-based HCV therapies in a real-world setting, and is consistent with findings observed in the clinical trial setting and previous real-world studies of simeprevir plus sofosbuvir treatment,” the researchers wrote. “This study suggests that few factors negatively impact the effectiveness of potent HCV treatment regimens such as simeprevir plus sofosbuvir.” – by Andy Polhamus
Disclosure: Alam reports consultation and speaking fees from Janssen. Please see the full study for a complete list of all other authors’ relevant financial disclosures.