In the Journals

Combination Regimens Show Similarly High Real-World SVR Rate in VA Cohort

The all-oral HCV combination therapies, Harvoni and Viekira XR both with and without ribavirin demonstrated similarly high real-world sustained virologic response rates in a cohort of Veterans Affairs patients, according to recent findings published in Alimentary Pharmacology and Therapeutics.

Our findings demonstrate that SVR rates with the new all–oral medications are exceedingly high,” Lisa I. Backus, MD, PhD, deputy chief consultant of measurement and reporting of Patient Care Services and Population Health Services at the Veterans Affairs Palo Alto Health Care System, told Healio.com/Hepatology. “In the past, real-world clinical effectiveness was often substantially lower than the efficacy reported in clinical trials but that no longer seems to be the case.  Advanced liver disease (as measured by a FIB-4 score > 3.25) still predicts decreased odds of SVR but many of the previous negative predictors no longer matter.  The medications have become so potent that many of the previous negative factors can be overcome.”

Lisa I. Backus

Clinical trial SVR rates for all-oral HCV regimens remain consistently above 90%, the researchers wrote. However, to inform HCV treatment decisions, real-world data are required.

Backus and colleagues performed an observational study of 6,961 veterans with HCV genotype 1 who were beginning 8 or 12-week therapy of ledipasvir and sofosbuvir (Harvoni, Gilead) with and without ribavirin (LDV/SOF ± RBV) (n = 4,478) or 12-week therapy of ombitasvir and paritaprevir and ritonavir all combined with dasabuvir (Viekira XR, AbbVie) with and without ribavirin (OPrD ± RBV) (n = 917) at 126 VA facilities.

Intention-to-treat SVR rates were 91.4% for LDV/SOF, 90% for LDV/SOF + RBV, 95.1% for OPrD and 85.8% for OPrD + RBV. SVR rates were 91.7% for those completing 8 weeks of LDV/SOF, 94.6% for those completing 12 weeks of LDV/SOF, 92.2% for those completing 12 weeks of LDV/SOF + RBV, 98% for those completing 12 weeks of OPrD and 95.5% for those completing 12 weeks of OPrD + RBV. Significant predictors of SVR were black race (OR = 0.71; 95% CI, 0.59-0.86), a BMI greater than 30 kg/m2 (OR = 0.72; 95% CI, 0.6-0.89), a FIB-4 score greater than 3.25 (OR = 0.6; 95% CI, 0.48-0.76) and an HCV subtype of 1b (OR = 1.38; 95% CI, 1.11-1.71). For those completing 12 weeks, a FIB-4 score greater than 3.25 and high BMI remained significant predictors.

The SVR rates in this study were similar to clinical trials, the researchers wrote. The reduced odds of SVR in black patients and with OPrD + RBV were most likely due to early discontinuation, as these factors were no longer significant for those completing a 12-week course.

“Given the demonstrated effectiveness, at this point the most pressing issue is getting people treated,” Backus said. “Fortunately in the VA we have funding for these medications so aggressive efforts continue to focus on testing those in the 1945-1965 birth cohort and on outreach to bring veterans in for treatment.” – by Will Offit

Disclosure: The researchers report no relevant financial disclosures.

The all-oral HCV combination therapies, Harvoni and Viekira XR both with and without ribavirin demonstrated similarly high real-world sustained virologic response rates in a cohort of Veterans Affairs patients, according to recent findings published in Alimentary Pharmacology and Therapeutics.

Our findings demonstrate that SVR rates with the new all–oral medications are exceedingly high,” Lisa I. Backus, MD, PhD, deputy chief consultant of measurement and reporting of Patient Care Services and Population Health Services at the Veterans Affairs Palo Alto Health Care System, told Healio.com/Hepatology. “In the past, real-world clinical effectiveness was often substantially lower than the efficacy reported in clinical trials but that no longer seems to be the case.  Advanced liver disease (as measured by a FIB-4 score > 3.25) still predicts decreased odds of SVR but many of the previous negative predictors no longer matter.  The medications have become so potent that many of the previous negative factors can be overcome.”

Lisa I. Backus

Clinical trial SVR rates for all-oral HCV regimens remain consistently above 90%, the researchers wrote. However, to inform HCV treatment decisions, real-world data are required.

Backus and colleagues performed an observational study of 6,961 veterans with HCV genotype 1 who were beginning 8 or 12-week therapy of ledipasvir and sofosbuvir (Harvoni, Gilead) with and without ribavirin (LDV/SOF ± RBV) (n = 4,478) or 12-week therapy of ombitasvir and paritaprevir and ritonavir all combined with dasabuvir (Viekira XR, AbbVie) with and without ribavirin (OPrD ± RBV) (n = 917) at 126 VA facilities.

Intention-to-treat SVR rates were 91.4% for LDV/SOF, 90% for LDV/SOF + RBV, 95.1% for OPrD and 85.8% for OPrD + RBV. SVR rates were 91.7% for those completing 8 weeks of LDV/SOF, 94.6% for those completing 12 weeks of LDV/SOF, 92.2% for those completing 12 weeks of LDV/SOF + RBV, 98% for those completing 12 weeks of OPrD and 95.5% for those completing 12 weeks of OPrD + RBV. Significant predictors of SVR were black race (OR = 0.71; 95% CI, 0.59-0.86), a BMI greater than 30 kg/m2 (OR = 0.72; 95% CI, 0.6-0.89), a FIB-4 score greater than 3.25 (OR = 0.6; 95% CI, 0.48-0.76) and an HCV subtype of 1b (OR = 1.38; 95% CI, 1.11-1.71). For those completing 12 weeks, a FIB-4 score greater than 3.25 and high BMI remained significant predictors.

The SVR rates in this study were similar to clinical trials, the researchers wrote. The reduced odds of SVR in black patients and with OPrD + RBV were most likely due to early discontinuation, as these factors were no longer significant for those completing a 12-week course.

“Given the demonstrated effectiveness, at this point the most pressing issue is getting people treated,” Backus said. “Fortunately in the VA we have funding for these medications so aggressive efforts continue to focus on testing those in the 1945-1965 birth cohort and on outreach to bring veterans in for treatment.” – by Will Offit

Disclosure: The researchers report no relevant financial disclosures.