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BROWSE SLIDES

Design

Acceptable ARV : FTC/TDF + EFV or RAL or RPV
LDV/SOF 90mg/400 mg : 1 pill qd

Objective

• Primary endpoint : SVR₁₂ (HCV RNA < 12 IU/ml) by intention to treat, with 2-sided 95% CI

Baseline characteristics and outcome

Adverse events , n (%)

• Serious adverse events : 1 (pneumonia)
• No discontinuation due to adverse event
• Common adverse events, mostly grade 1 :
  • Nasal congestion 16%)
  • Myalgia (14%)
  • Headache (10%)
  • Fatigue (10%)
  • Diarrhea (8%)
  • Nausea (6 %)
  • Constipation (6%)
  • Urinary tract infection (6%)
• Grade 4 events : 4 (pneumonia, decrease neutrophil count, elevated AST, CK elevation)
• No significant changes in serum creatinine or eGFR

Summary

• In this open- label, uncontrolled, non randomised study, LDV/SOF single tablet regimen was associated with high rates of SVR in patients with HCV genotype 1 and HIV co-infection, similar to that observed inpatients monoinfected with HCV genotype 1
• Most adverse events were mild (grade 1-2) and clinically manageable
• Limitations
  • Low sample size
  • Exclusion of cirrhosis
  • Restriction in antiretroviral regimen (exclusion of PI and NNRTI)
  • Exclusion of patients with low CD4 cell counts