ASTRAL-5

ASTRAL-5 study: SOF/VEL in HIV coinfection

Wyles D, Clin Infect Dis 2017, Epub ahead of print

Anti-HCV
Sofosbuvir
Velpatasvir (GS-5816)
Genotype
1
2
3
4
Treatment history
Naive
IFN-Experienced
Cirrhosis
Yes
No
Special population
HIV co-infection

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Design


* Metavir F4 or Ishak 5-6 or Fibroscan > 12.5 kPa or Fibrotest > 0.75 and APRI > 2

Objective

  • SVR12 (HCV RNA < 15 IU/ml), by ITT with two-sided 95% CI (= 5.9% in both directions from an expected SVR12 of 90%)

Baseline characteristics

SRV12 overall, by genotype and by cirrhosis or prior treatment, % (95% CI), ITT

  • No impact of baseline NS5A RAVs: all 13 patients with baseline NS5A RASs (cutoff 15%) achieved SVR12

Adverse events, %


No HIV rebound

Laboratory abnormalities, %

3 patients, all receiving TDF-containing regimens, had a change from baseline of = 0.4 mg/dl in serum creatinine while on treatment
CD4+ counts remained stable and no patient experienced HIV virologic rebound

Summary

  • SOF/VEL for 12 weeks resulted in overall 95% SVR12 in HIV coinfected patients
    • 100% SVR12 in patients with cirrhosis
    • 96% SVR12 in patients with prior failure to HCV therapy
  • Presence of baseline RAVs did not impact efficacy
  • Treatment was safe and well tolerated, including with TDF-based boosted regimens
  • In conclusion, SOF/VEL for 12 weeks provides a simple, safe, and highly effective treatment for patients coinfected with HCV and HIV-1