Harvoni produces high SVR rates in real-world cohort of veterans

In a real-world cohort of veterans with hepatitis C virus infection genotype 1, Harvoni-based therapy produced sustained virologic response rates over 90%, according to published findings.

“HCV disproportionately affects the veteran population, and this population is often underrepresented in clinical trials, largely due to complicating comorbidities. … With the rapid uptake of [Harvoni] regimens across health care settings and variations that often occur in clinical practice, we examined real-world outcomes in the diverse HCV-infected veteran population receiving this regimen,” Lisa I. Backus, MD, PhD, of the Veterans Affairs Palo Alto Health Care System, Palo Alto, Calif., and colleagues wrote.

The researchers evaluated data of 4,834 treatment-naive veterans from the VA’s Clinical Case Registry for HCV who initiated treatment with Harvoni (ledipasvir/sofosbuvir, Gilead Sciences) with or without ribavirin at 124 different VA clinical sites. The mean age of the cohort was 61.3 years and 96.1% were men.

SVR results were available for 4,068 veterans. SVR was reached in 91.3% of veterans treated with ledipasvir/sofosbuvir without ribavirin (3,191/3,495) and 92% of veterans (527/573) treated with ledipasvir/sofosbuvir with ribavirin (P = .65). SVR rates were lower in black veterans compared with white veterans.

Multivariate analysis showed black race (OR = 0.7; 95% CI, 0.54-0.9) and Fibrosis-4 (FIB-4) score greater than 3.25 (OR = 0.56; 95% CI, 0.43-0.71) were independently associated with decreased likelihood of SVR, whereas age, sex, BMI, decompensated liver disease, diabetes, genotype 1 subtype and regimen did not predict SVR.

In models limited to veterans who completed 12 weeks of treatment, black race did not remain a significant predictor of SVR, whereas FIB-4 greater than 3.25 did (OR = 0.35, 95% CI, 0.24-0.5).

In veterans without cirrhosis and a 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 treatment and 96.6% for those who completed 12 weeks of therapy (875/906; P = .001).

“[Veterans] 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,” the researchers wrote.

The researchers concluded: “SVR rates with [ledipasvir/sofosbuvir with or without ribavirin] nearly matched the rates reported in clinical trials and were consistently high across all subgroups.” – by Melinda Stevens