Efficacy and Safety of Sofosbuvir/Daclatasvir in the Treatment of COVID-19: A Randomized, Controlled Study

Yakoot, Mostafa; Eysa, Basem; Gouda, Essam; Hill, Andrew; Sa, Helmy; Mr, Elsayed; Qavi, Ambar; McCann, Kaitlyn; Elrouby, Ola; Mohamed, Abdelrahman; Reyad, Ehab M.; Mm, Fawzi; Elmandouh, S; Abdellatif, W; Aa, Zidan; Adel, Asil; Hassany, Mohamed

doi:10.2139/ssrn.3705289

Cited by 5 publications

(14 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The results from this double-blind randomized trial are not consistent with earlier clinical trials of sofosbuvir/daclatasvir. 7–9 , 12 In a combined analysis of the four earlier randomized trials and the DISCOVER results presented here, there is no significant benefit associated with sofosbuvir/daclatasvir on hospital discharge ( Figure S1 ). The four earlier trials conducted in Iran and Egypt had a total sample size of 265 patients compared with 1083 patients in the DISCOVER trial.…”

Section: Discussionmentioning

confidence: 75%

“…In early 2020 there were four small clinical trials in a total of 265 patients that evaluated the efficacy of sofosbuvir/daclatasvir in combination with other antivirals, such as lopinavir/ritonavir, hydroxychloroquine and ribavirin, in hospitalized patients with COVID-19. 7–9 , 12 Results from these four trials were encouraging. Three have been analysed together in a pooled meta-analysis, showing that mortality and time to hospital discharge was slightly improved in patients receiving sofosbuvir/daclatasvir compared with standard of care.…”

Section: Introductionmentioning

confidence: 88%

See 1 more Smart Citation

Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)

Mobarak¹,

Salasi

Hormati

et al. 2021

Journal of Antimicrobial Chemotherapy

Self Cite

View full text Add to dashboard Cite

Background The combination of sofosbuvir and daclatasvir has shown preliminary efficacy for hospitalized patients with COVID-19 in four open-label studies with small sample sizes. This larger trial aimed to assess if the addition of sofosbuvir/daclatasvir to standard care improved clinical outcomes in hospitalized patients with COVID-19. Methods This was a placebo-controlled, double-blind, randomized clinical trial in adults hospitalized with COVID-19 at 19 hospitals in Iran. Patients were randomized to oral sofosbuvir/daclatasvir 400/60 mg once-daily or placebo in addition to standard of care. Patients were included if they had positive PCR or diagnostic chest CT, O2 saturation <95% and compatible symptoms. The primary outcome was hospital discharge within 10 days of randomization. Secondary outcomes included mortality and time to clinical events. The trial is registered on the Iran Registry of Clinical Trials under IRCT20200624047908N1. Results Between July and October 2020, 1083 patients were randomized to either the sofosbuvir/daclatasvir arm (n = 541) or the placebo arm (n = 542). No significant difference was observed in the primary outcome of hospital discharge within 10 days, which was achieved by 415/541 (77%) in the sofosbuvir/daclatasvir arm and 411/542 (76%) in the placebo arm [risk ratio (RR) 1.01, 95% CI 0.95–1.08, P = 0.734]. In-hospital mortality was 60/541 (11%) in the sofosbuvir/daclatasvir arm versus 55/542 (10%) in the placebo arm (RR 1.09, 95% CI 0.77–1.54, P = 0.615). No differences were observed in time to hospital discharge or time to in-hospital mortality. Conclusions We observed no significant effect of sofosbuvir/daclatasvir versus placebo on hospital discharge or survival in hospitalized COVID-19 patients.

show abstract

Section: Discussionmentioning

confidence: 75%

Section: Introductionmentioning

confidence: 88%

Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)

Mobarak¹,

Salasi

Hormati

et al. 2021

Journal of Antimicrobial Chemotherapy

Self Cite

View full text Add to dashboard Cite

show abstract

“…After screening, eleven randomized controlled trials [11][12][13][14][15][16][17][18][19][20][21] were included (Figure 1), with a total of 1,110 patients who were randomized to the intervention arm and received sofosbuvir-based direct-acting antiviral agents and 1,051 patients who were randomized to the control arm and did not receive sofosbuvir-based directacting antiviral agents. All the included trials [11][12][13][14][15][16][17][18][19][20] assessed and reported mortality outcomes, while nine of the included trials [13][14][15][16][17]21] assessed and reported outcomes on severe illness. In addition, seven of the included trials [11,12,14,15,[18][19][20] were performed in Iran, whereas the remaining four randomized trials [13,16,17,21] were originated from Egypt.…”

Section: Resultsmentioning

confidence: 99%

Clinical outcomes of sofosbuvir-based antivirals in patients with COVID-19: a systematic review and meta-analysis of randomized trials

Kow

Javed

Ramachandram

et al. 2021

Expert Review of Anti-infective Therapy

View full text Add to dashboard Cite

BackgroundFew randomized trials evaluated the effect of combination therapy of Sofosbuvir-based direct-acting antivirals on mortality risk in patients with COVID-19. Therefore, we aimed to summarize the overall evidence in the form of a systematic review and meta-analysis. MethodsA systematic literature search with no language restriction was performed in electronic databases and preprint repositories to identify eligible randomized trials published up to July 8, 2021. A random-effects model was used to estimate the pooled odds ratio (OR) for outcomes of interest using sofosbuvir combined with direct-acting antiviral agents relative to non-use of sofosbuvir-based direct-acting antiviral agents at 95% confidence intervals (CI). ResultsThe estimated effect of sofosbuvir-based direct-acting antiviral agents on the mortality risk indicated a significantly reduced risk (pooled odds ratio = 0.59; 95% confidence interval 0.36 to 0.99) with inadequate evidence against our model hypothesis of no significant difference at the current sample size. However, no statistically significant difference in the odds of development of composite endpoint of severe illness (pooled odds ratio = 0.79; 95% confidence interval 0.43 to 1.44), with the administration of a combination of sofosbuvir-based direct-acting antiviral agents among patients with COVID-19, relative to nonadministration of sofosbuvir-based direct-acting antiviral agents. ConclusionThe sofosbuvir-based direct-acting antiviral agents have no protective effects against the development of severe illness in patients with COVID-19 with the current dosing regimen. Whether sofosbuvir-based direct-acting antiviral agents could offer mortality benefits would require further investigations.

show abstract

“…This combination therapy showed no statistically significant improvement in remission or mortality when compared to lopinavir/ritonavir (LPV/r) [32] (Table 3). SOF/DCV, however, significantly improved recovery rates [31,33], as well as significantly reduced hospitalization [34,35] compared to standard of care (SoC) control groups in two small studies. Evidence, therefore, is accumulating on the combination's efficacy in improving these outcomes and further studies may provide greater clarity on its role in treating COVID-19 [36].…”

Section: Favipiravir (Fpv)mentioning

confidence: 96%

Evidence of the Clinical Efficacy of Antiviral Agents against SARS-CoV-2

Welman¹,

Outhoff²

2021

Int j pharm res allied sci

View full text Add to dashboard Cite

Efficacy and Safety of Sofosbuvir/Daclatasvir in the Treatment of COVID-19: A Randomized, Controlled Study

Cited by 5 publications

References 0 publications

Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)

Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)

Clinical outcomes of sofosbuvir-based antivirals in patients with COVID-19: a systematic review and meta-analysis of randomized trials

Evidence of the Clinical Efficacy of Antiviral Agents against SARS-CoV-2

Contact Info

Product

Resources

About