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The accuracy of baseline viral load for predicting the efficacy of elbasvir/grazoprevir in participants with hepatitis C virus genotype 1a infection: An integrated analysis

2018; Wiley; Volume: 26; Issue: 3 Linguagem: Inglês

10.1111/jvh.13037

1365-2893

Lawrence Serfaty, Ira M. Jacobson, Jürgen K. Rockstroh, Frederick L. Altice, Peggy Hwang, Eliav Barr, Michael Robertson, Barbara Haber,

Chronic Lymphocytic Leukemia Research

Summary European treatment guidelines for hepatitis C virus ( HCV ) infection recommend that people with genotype ( GT ) 1a infection and baseline viral load ≤800 000 IU / mL receive elbasvir/grazoprevir ( EBR / GZR ) for 12 weeks, and those with baseline viral load >800 000 IU / mL receive EBR / GZR plus ribavirin for 16 weeks. This analysis was conducted to clarify whether baseline viral load can serve as an accurate, sensitive or specific stratification factor for defining EBR / GZR regimens. In this post hoc, integrated analysis, participants with GT 1a infection who received EBR 50 mg/ GZR 100 mg for 12 weeks were stratified according to baseline viral load. Sustained virologic response at 12 weeks post‐treatment was achieved by 95.2% (911/957) of participants and was higher among participants with baseline viral load ≤800 000 IU / mL vs >800 000 IU / mL (98.5% vs 93.9%). The 800 000 IU / mL threshold had a positive predictive value of 98.5%, a negative predictive value of 6.1%, a specificity of 91.3%, a sensitivity of 28.4% and an overall accuracy of 31.5%. A baseline viral load cutpoint of 800 000 IU / mL had high positive predictive value and specificity but poor negative predictive value, sensitivity and accuracy in predicting treatment outcomes in this population. Baseline NS 5A resistance‐associated substitutions ( RAS s) were detected in 25% (1/4) of virologic failures with baseline viral load ≤800 000 IU / mL and 59.5% (25/42) of those with baseline viral load >800 000 IU / mL . Overall, these data suggest that, compared with the use of a baseline viral load cutpoint, baseline testing for NS 5A RAS s enables more individuals to receive the 12‐week EBR / GZR regimen without compromising the opportunity for SVR.