Efficacy and safety of sofosbuvir plus daclatasvir or ravidasvir in patients with COVID-19: A randomized controlled

Sherif Abbass1, Ehab Kamal2, Mohsen Salama1

  • 1National Liver Institute, Shebeen El-Kom, Menoufia, Egypt.

Insights

Sofosbuvir plus daclatasvir (SOF-DCV) significantly improved symptoms and oxygen saturation in COVID-19 patients compared to standard care. This repurposed antiviral combination offers a safe and effective treatment option for moderate to severe coronavirus disease-2019.

Area of Science:

  • Virology
  • Infectious Diseases
  • Clinical Pharmacology

Background:

  • Limited approved treatments exist for COVID-19.
  • Repurposing existing antiviral drugs is a rapid strategy for effective therapy.
  • Evaluating novel combinations for moderate to severe COVID-19 is crucial.

Purpose of the Study:

  • To assess the efficacy and safety of sofosbuvir (SOF) plus daclatasvir (DCV) or ravidasvir (RDV) combined with standard of care (SOC) for COVID-19.
  • To compare outcomes between SOF-DCV/RDV plus SOC versus SOC alone.
  • To evaluate clinical endpoints including symptom resolution, oxygen saturation, and ICU admission.

Main Methods:

  • A multicentre, parallel, randomized controlled, open-label trial.
  • 120 patients with moderate to severe COVID-19 were randomized.
  • 10-day treatment with SOF-DCV or SOF-RDV plus SOC, compared to SOC alone, with 7-day follow-up.

Main Results:

  • SOF-DCV plus SOC significantly reduced symptom burden and prevented deterioration (ICU admission, mechanical ventilation) compared to SOC alone.
  • Oxygen saturation significantly improved in the SOF-DCV group from Day 4.
  • SOF-RDV plus SOC did not demonstrate significant improvements in primary endpoints.

Conclusions:

  • Sofosbuvir plus daclatasvir (SOF-DCV) is effective and safe as an add-on therapy for moderate to severe COVID-19.
  • This combination shows promise in improving clinical outcomes and preventing severe disease progression.
  • Ravidasvir combination did not yield significant benefits in this study.

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