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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.
Abstract:
Only a few treatments are approved for coronavirus disease-2019 (COVID-19) infections, with continuous debate about their clinical impact. Repurposing antiviral treatments might prove the fastest way to identify effective therapy. This trial aimed to evaluate the efficacy and safety of sofosbuvir (SOF) plus daclatasvir (DCV) or ravidasvir (RDV) added to standard care (SOC) for patients with moderate and severe COVID-19 infection. Multicentre parallel randomized controlled open-label trial. One hundred and twenty eligible patients with moderate and severe COVID-19 infection were randomized to one of the study arms. Ten days of treatment with SOF plus DCV or RDV in addition to the standard of care compared to SOC. Follow up in 7 days. Sum of the counted symptoms at 7 and 10 days, mean change in oxygen saturation level, viral negativity, and rate of intensive care unit (ICU) admission. Compared to SOC, the SOF-DCV group experienced a significantly lower sum of the counted symptoms (fever, headache, generalized aches, or respiratory distress) combined with no evidence of deterioration (ICU admission and mechanical ventilation) on Days 7 and 10 of treatment. Oxygen saturation also significantly improved among the SOF-DCV group compared to SOC starting from Day 4. The study also showed positive trends regarding the efficacy of SOF-DCV with a lower incidence of mortality. On the other hand, adding SOF-RDV to SOC did not show significant improvements in endpoints. The results support the efficacy and safety of SOF-DCV as an add-on to SOC for the treatment of moderate to severe COVID-19 infections.
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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