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BROWSE SLIDES

Design

* Metavir F4 or F ibroscan > 12.5 kPa or FibroTest > 0.75 + APRI > 2
** TDF or ABC + 3TC or FTC + RAL or DTG or RPV

Objective

• SVR₁₂ (HCV RNA < 15 IU/ mL ) by intention to treat analysis , 99% power to establish superiority over historical reference rate of 70% (PHOTON-1 Study ), with 1-sided 2.5% alpha level

Baseline characteristics

SVR₁₂ (HCV RNA < 15 IU/ mL), % (95% CI)

SVR₁₂ by subgroups

• No differences for key subgroups characteristics (gender, age, race, IL28B genotype, cirrhosis, baseline HCV RNA, RAL vs DTG vs RPV)
• ABC-containing : SVR₁₂ = 93.6% vs TDF-containing : SVR₁₂ = 97.6%

Relapse, n = 5

• All non-cirrhotic, g enotype 1a, N = 4 ; g enotype 4, N = 1
• 4/5 were receiving ART : TDF-based ART N = 3 ; ABC-based ART N = 1

Re-infection, n = 2

• The 2 patients were infected with a different HCV genotype during follow-up compared with baseline : Genotype 1a and Genotype 1b at enrolment ; Genotype 3 at f ollow-up W12 in both
• Per protocol, these patients were classified as a failure for analysis, but sequencing data are consistent with post-treatment re-infection

Adverse events, N (%)

* convulsion, pneumonia , erysipela , acute psychosis and urinary retention , ulnar fracture, spontaneous bacterial peritonitis

Laboratory abnormalities (treatment period plus first 14 days of follow-up), N (%)

Summary

• A 12-week regimen of the oral fixed dose combination of once-daily, single-tablet of grazoprevir/elbasvir, achieved an overall SVR₁₂ of 96% in patients with HCV genotype 1 or 4 infection and HCV co-infection
  • Comparable response rates to HCV mono-infected genotype 1 and 4
  • Comparable SVR across all patients sub-groups
• Low rate of adverse events
• HIV breakthrough
  • 2 patients with transient viremia and subsequent re-suppression with no change in ARV regimen
  • No change in CD4+ cell counts
• Limitation
  • No active-control group