HCV: low-dose SOF safe with DCV in CKD, ESRD

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Takeaway

  • A regimen of low-dose sofosbuvir (SOF) plus full-dose daclatasvir (DCV) is safe and effective for eradicating HCV in patients with chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) 2.

Why this matters

  • If safety and efficacy are confirmed, low-dose SOF could provide an alternative to suboptimal peginterferon ± ribavirin for patients with CKD/ESRD residing in countries where newer direct-acting antiviral regimens are unavailable.

Study design

  • Real-world study conducted in India, involving 65 patients (mean age, 42.9 years; 61.5% male) with HCV and eGFR 2; 83% were on hemodialysis.
  • All received a half-pill of SOF (200 mg) plus 60 mg DCV once-daily for 12 weeks (24 weeks in HCV-3 cirrhosis).
  • Primary endpoint was sustained virologic response at 12 weeks posttherapy (SVR12).
  • Funding: None.

Key results

  • HCV-1 was most common (n=42, 64.6%), followed by HCV-3 (n=22, 33.8%) and HCV-2 (n=1, 1.5%); median viral load was 1.65 x 106 IU/mL.
  • 32.3% of patients had cirrhosis; 15.4% were treatment-experienced.
  • All patients achieved SVR12.
  • No serious adverse events were reported.
  • 5 patients (7.7%) reported minor adverse events, including insomnia (n=4; 6.2%) and pruritis (n=1; 1.5%).

Limitations

  • Single-arm, monocentric design with small sample size.