Real-world effectiveness data are needed to inform hepatitis C virus ( HCV ) treatment decisions. The uptake of Ledipasvir and Sofosbuvir ( LDV/SOF; Harvoni ) regimens across health care settings has been rapid, but variations often occur in clinical practice.
The aim of this study was to assess sustained virologic response ( SVR ) of Ledipasvir and Sofosbuvir with or without Ribavirin ( RBV ) in routine medical practice.
This observational, intent-to-treat cohort was comprised of 4,365 genotype 1, treatment-naive, HCV-infected veterans treated with Ledipasvir and Sofosbuvir with or without Ribavirin.
SVR rates were 91.3% ( 3,191/3,495 ) for LDV/SOF and 92.0% ( 527/573 ) for LDV/SOF+RBV ( P = 0.65 ).
African American race ( odds ratio 0.70, 95% confidence interval 0.54-0.90, P = 0.004 ) and FIB-4 more than 3.25 ( odds ratio 0.56, 95% confidence interval 0.43-0.71, P less than 0.001 ) were independently associated with decreased likelihood of SVR; age, sex, body mass index, decompensated liver disease, diabetes, genotype 1 subtype, and regimen did not predict SVR.
In models limited to those who completed 12 weeks of treatment, African American race was no longer a significant predictor of SVR but FIB-4 more than 3.25 ( OR=0.35, 95% confidence interval 0.24-0.50, P less than 0.001 ) remained.
Among those without cirrhosis ( defined by FIB-4 less than or equal to 3.25 ) and with baseline HCV RNA less than 6,000,000 IU/mL, SVR rates were 93.2% ( 1,020/1,094 ) for those who completed 8 weeks of therapy and 96.6% ( 875/906 ) for those who completed 12 weeks of therapy ( P = 0.001 ).
In conclusion, in this real-world cohort, SVR rates with LDV/SOF±RBV nearly matched the rates reported in clinical trials and were consistently high across all subgroups; those without cirrhosis but with HCV RNA less than 6,000,000 IU/mL were less likely to achieve SVR with 8 weeks compared to 12 weeks of therapy, although the numeric difference in SVR rates was small. ( Xagena )
Backus LI et al, Hepatology 2016;64:405-414