Other substances

Sofosbuvir

An antiviral nucleoside analogue.

Phase of research

Potential treatment - clinical evidence

How it helps

Antiviral

Drug status

Used to treat other disease

Supporting references

Contradictory references

AI-suggested references

Clinical trials

General information

Sofosbuvir is a prodrug and a nucleoside analogue that inhibits hepatitis C virus RNA-dependent RNA polymerase (NCIt). It might inhibit the SARS-CoV-2 RNA-dependent RNA polymerase at the early stages of viral replication (Sacramento et al., 2021).

Sofosbuvir on DrugBank
Sofosbuvir on PubChem
Sofosbuvir on Wikipedia

Marketed as

SOVALDI

C[C@@H](C(=O)OC(C)C)N[P@](=O)(OC[C@@H]1[C@H]([C@@]([C@@H](O1)N2C=CC(=O)NC2=O)(C)F)O)OC3=CC=CC=C3

Supporting references

Link	Tested on	Impact factor	Notes	Publication date
Anti-HCV, nucleotide inhibitors, repurposing against COVID-19.	in silico			Feb/28/2020
Sofosbuvir protects human brain organoids against SARS-CoV-2 Preprint	iPSC-derived human brain organoids			May/31/2020
The in vitro antiviral activity of the anti-hepatitis C virus (HCV) drugs daclatasvir and sofosbuvir against SARS-CoV-2 Preprint	HuH-7 and Calu-3 cells			Jun/16/2020
Sofosbuvir and daclatasvir compared with standard of care in the treatment of patients admitted to hospital with moderate or severe coronavirus infection (COVID-19): a randomized controlled trial Severe severity Small molecule Non-randomized controlled open trial Moderate severity	Patients	5.44	The fixed-dose with daclatasvir significantly shortened median duration of hospitalization versus standard care. Sample size: 33 + 33 control. Dosage: 400 mg sofosbuvir and 60 mg daclatasvir in addition to standard care for 14 days. Endpoint: Clinical recovery within 14 days of enrolment (primary).	Aug/19/2020
The impact of sofosbuvir/daclatasvir or ribavirin in patients with severe COVID-19 Small molecule Non-randomized controlled open trial	Patients	5.44	In a fixed-dose with daclatasvir significantly reduced time to clinical improvement and caused less side effects when compared to ribavirin treatment. Sample size: 35 + 27 (ribavirin arm). Dosage: 400 mg sofosbuvir and 60 mg daclatasvir twice a day for a maximum of 14 days.	Aug/18/2020
MCCS: a novel recognition pattern-based method for fast track discovery of anti-SARS-CoV-2 drugs 3CLpro Small molecule In silico	in silico	8.99	Predicted to inhibit the SARS-CoV-2 3C-like protease.	Oct/20/2020

AI-suggested references

Link	Publication date
Efficacy of combined Sofosbuvir and Daclatasvir in the treatment of COVID-19 patients with pneumonia: a multicenter Egyptian study.	Jul/15/2021
Incorporation efficiency and inhibition mechanism of 2'-substituted nucleotide analogs against SARS-CoV-2 RNA-dependent RNA polymerase.	Sep/22/2021
Interaction of the renin inhibitor aliskiren with the SARS-CoV-2 main protease: a molecular docking study.	Sep/13/2021
Drug Repurposing: A Strategy for Discovering Inhibitors against Emerging Viral Infections.	Aug/14/2020
HCV RdRp, sofosbuvir and beyond.	Jan/02/2021
Structural insight into the binding interactions of NTPs and nucleotide analogues to RNA dependent RNA polymerase of SARS-CoV-2.	Jul/19/2021
Synergistic Interferon-Alpha-Based Combinations for Treatment of SARS-CoV-2 and Other Viral Infections.	Dec/11/2021
Dual targeting of RdRps of SARS-CoV-2 and the mucormycosis-causing fungus: an in silico perspective	Jun/30/2020
Activation of Tenofovir Alafenamide and Sofosbuvir in the Human Lung and Its Implications in the Development of Nucleoside/Nucleotide Prodrugs for Treating SARS-CoV-2 Pulmonary Infection	Oct/11/2021
Nucleotide Analogues as Inhibitors of SARS-CoV-2 Polymerase, a Key Drug Target for COVID-19	Aug/05/2020
On a knife's edge of a COVID-19 pandemic: is containment still possible?	Mar/09/2020
In silico studies of selected multi-drug targeting against 3CLpro and nsp12 RNA-dependent RNA-polymerase proteins of SARS-CoV-2 and SARS-CoV.	Mar/25/2021
SARS-CoV-2 RNA dependent RNA polymerase (RdRp) targeting: an in silico perspective	May/06/2020
Sofosbuvir as a potential option for the treatment of COVID-19	May/11/2020
Structural analogues of existing anti-viral drugs inhibit SARS-CoV-2 RNA dependent RNA polymerase: A computational hierarchical investigation	Mar/05/2021
Evaluation of the efficacy of sofosbuvir plus daclatasvir in combination with ribavirin for hospitalized COVID-19 patients with moderate disease compared with standard care: a single-centre, randomized controlled trial	Aug/20/2020
Surface plasmon resonance approach to study drug interactions with SARS-CoV-2 RNA-dependent RNA polymerase highlights treatment potential of suramin	Apr/16/2021
In vitro antiviral activity of the anti-HCV drugs daclatasvir and sofosbuvir against SARS-CoV-2, the aetiological agent of COVID-19	Apr/22/2021
Antiviral drugs against severe acute respiratory syndrome coronavirus 2 infection triggering the coronavirus disease-19 pandemic	Dec/04/2020
Repositioning HIV protease inhibitors and nucleos(t)ide RNA polymerase inhibitors for the treatment of SARS-CoV-2 infection and COVID-19	Mar/04/2021
Sofosbuvir/daclatasvir regimens for the treatment of COVID-19: an individual patient data meta-analysis	Jul/28/2021
A library of nucleotide analogues terminate RNA synthesis catalyzed by polymerases of coronaviruses that cause SARS and COVID-19	Jun/18/2020
Structure and dynamics of SARS-CoV-2 proofreading exoribonuclease ExoN	Feb/16/2022
A bacterial artificial chromosome (BAC)-vectored noninfectious replicon of SARS-CoV-2	Jul/26/2020
Ribavirin, Remdesivir, Sofosbuvir, Galidesivir, and Tenofovir against SARS-CoV-2 RNA dependent RNA polymerase (RdRp): A molecular docking study	Mar/25/2020
Sofosbuvir terminated RNA is more resistant to SARS-CoV-2 proofreader than RNA terminated by Remdesivir	Jul/06/2020
Nucleotide analogues as inhibitors of SARS-CoV Polymerase	Oct/31/2020
The anti-HCV, Sofosbuvir, versus the anti-EBOV Remdesivir against SARS-CoV-2 RNA dependent RNA polymerase in silico	Jan/03/2021
Overcoming Culture Restriction for SARS-CoV-2 in Human Cells Facilitates the Screening of Compounds Inhibiting Viral Replication	Jan/24/2021
Remdesivir is a direct-acting antiviral that inhibits RNA-dependent RNA polymerase from severe acute respiratory syndrome coronavirus 2 with high potency	Jan/16/2022
Efficacy and safety of sofosbuvir/ledipasvir in treatment of patients with COVID-19; A randomized clinical trial	Nov/10/2020
In silico analysis of RNA-dependent RNA polymerase of the SARS-CoV-2 and therapeutic potential of existing antiviral drugs.	Jun/23/2021
Efficacy of Sofosbuvir plus Ledipasvir in Egyptian patients with COVID-19 compared to standard treatment: a randomized controlled trial	Dec/24/2021
Asunaprevir, a Potent Hepatitis C Virus Protease Inhibitor, Blocks SARS-CoV-2 Propagation	Apr/20/2021
Alkaloids and flavonoids from African phytochemicals as potential inhibitors of SARS-Cov-2 RNA-dependent RNA polymerase: an in silico perspective	Jan/13/2022
Prediction of the SARS-CoV-2 (2019-nCoV) 3C-like protease (3CL pro) structure: virtual screening reveals velpatasvir, ledipasvir, and other drug repurposing candidates	Feb/21/2020
Efficacy and safety of the sofosbuvir/velpatasvir combination for the treatment of patients with early mild to moderate COVID-19	Apr/17/2020
Evaluation of the effect of sofosbuvir and daclatasvir in hospitalized COVID-19 patients: a randomized double-blind clinical trial (DISCOVER)	Nov/28/2021
Efficacy and safety of sofosbuvir/velpatasvir versus the standard of care in adults hospitalized with COVID-19: a single-centre, randomized controlled trial	Jun/30/2020
Sofosbuvir as Repurposed Antiviral Drug Against COVID-19: Why Were We Convinced to Evaluate the Drug in a Registered/Approved Clinical Trial?	Apr/29/2020
Combination of antiviral drugs inhibits SARS-CoV-2 polymerase and exonuclease and demonstrates COVID-19 therapeutic potential in viral cell culture	Feb/22/2022
Sofosbuvir as a potential alternative to treat the SARS-CoV-2 epidemic	Jun/09/2020
Anti-HCV, nucleotide inhibitors, repurposing against COVID-19	Apr/23/2021
Knowledge-based repositioning of the anti-HCV direct antiviral agent Sofosbuvir as SARS-CoV-2 treatment	May/12/2020
Efficacy and safety of sofosbuvir plus daclatasvir or ravidasvir in patients with COVID-19: A randomized controlled trial	Mar/26/2021

Clinical trials

ID	Title	Status	Phase	Start date	Completion date
NCT04561063	COVID-19 Prophylaxis South Africa (COVER HCW)	Recruiting	Phase 2	Dec/08/2020	Feb/28/2022
Alternative id - EZ-SS-025 Interventions - Drug: Nitazoxanide\|Drug: Sofosbuvir/Daclatasvir Study type - Interventional Study results - No Results Available Locations - Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, Gauteng, South Africa\|Sunnyside Office Park, Johannesburg, Gauteng, South Africa Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Prevention Enrollment - 1950 Age - 18 Years to 99 Years (Adult, Older Adult) Outcome measures - Number of SARS-CoV-2 infections\|Duration of symptoms\|Maximum score on WHO Ordinal Scale\|Time to onset of SARS-CoV-2 infection\|Number of symptomatic SARS-CoV-2 infections\|Number of asymptomatic SARS-CoV-2 infections\|Peak score on modified Flu PRO
NCT04443725	Efficacy and Safety of Anti HCV Drugs in the Treatment of COVID-19	Not yet recruiting	Phase 2\|Phase 3	Jul/01/2020	Dec/01/2020
Alternative id - CUKA-003 Interventions - Drug: Hydroxychloroquine , Sofosbuvir, daclatasvir\|Drug: Standard of care treatment Study type - Interventional Study results - No Results Available Locations - Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 100 Age - 18 Years to 65 Years (Adult, Older Adult) Outcome measures - Virological cure
NCT04497649	Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients	Recruiting	Phase 2\|Phase 3	Jul/01/2020	Apr/10/2021
Alternative id - Tanta sofosbuvir covid Interventions - Drug: Sofosbuvir\|Drug: Daclatasvir Study type - Interventional Study results - No Results Available Locations - Cairo and Tanta Universitities, Tanta, Egypt Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)\|Primary Purpose: Treatment Enrollment - 100 Age - Child, Adult, Older Adult Outcome measures - Number of patients with improvement or mortality
NCT04498936	Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19	Completed	Phase 4	Jul/15/2020	Oct/30/2020
Alternative id - COVID-19 treatment Interventions - Drug: Sofosbuvir and Ledipasvir\|Drug: Nitazoxanide Study type - Interventional Study results - No Results Available Locations - 15th May Hospital, Helwan, Cairo, Egypt\|Assiut University Hospital, Assiut, Egypt Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 240 Age - 12 Years to 65 Years (Child, Adult, Older Adult) Outcome measures - Change of PCR from positive to negative\|Clinical improvement\|Adverse events
NCT04460443	Sofosbuvir in Treatment of COVID 19	Recruiting	Phase 2\|Phase 3	Aug/01/2020	Aug/31/2021
Alternative id - sofosbuvir Interventions - Drug: sofosbuvir\|Drug: Sofosbuvir ledipsavir\|Drug: Daclatasvir Study type - Interventional Study results - No Results Available Locations - Sherief Abd-Elsalam, Tanta, Egypt Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 60 Age - Child, Adult, Older Adult Outcome measures - Number of patients with response to treatment
NCT04773756	Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt	Completed	Phase 4	Nov/01/2020	Dec/12/2020
Alternative id - 0305032 Interventions - Drug: Sofosbuvir 400 MG/ Daclatasvir 60mg Study type - Interventional Study results - No Results Available Locations - Amr Aly Abd elmoety, Alexandria, Egypt Study designs - Allocation: N/A\|Intervention Model: Single Group Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 54 Age - 12 Years to 90 Years (Child, Adult, Older Adult) Outcome measures - evaluate the combined effect of Sofosbuvir and Daclatasvir in treatment of patients with mild-moderate Covid-19.
NCT04535869	Efficacy and Safety of Direct Anti HCV Drugs in the Treatment of SARS-COV-2 (COVID-19)	Recruiting	Phase 3	Dec/28/2020	Sep/03/2021
Alternative id - MS.20.08.1214 Interventions - Drug: Sofosbuvir 400 MG plus Daclatasvir 200mg Study type - Interventional Study results - No Results Available Locations - Mansoura Faculty of Medicine, Mansoura, Dakahlyia, Egypt Study designs - Allocation: Non-Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 50 Age - 18 Years and older (Adult, Older Adult) Outcome measures - rate of virological cure by Rt -PCR for COVID -19using the triple therapy as compared to standard treatment\|resolution of pneumonia BY high resolution Computed tomography
NCT04532931	COVID-19 Treatment in South Africa	Completed	Phase 2	Sep/03/2020	Aug/23/2021
Alternative id - SP-PA-COV-202 Interventions - Other: Standard of care (Paracetamol)\|Drug: Artesunate-amodiaquine\|Drug: Pyronaridine-artesunate\|Drug: Favipiravir plus Nitazoxanide\|Drug: Sofosbuvir/daclatasvir Study type - Interventional Study results - No Results Available Locations - Ezintsha, Wits Reproductive Health & HIV Institute University of the Witwatersrand, Johannesburg, South Africa Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: None (Open Label)\|Primary Purpose: Treatment Enrollment - 192 Age - 18 Years to 65 Years (Adult, Older Adult) Outcome measures - Incidence of SARS-CoV-2 clearance\|Time to clearance of nasal SARS-CoV-2\|Median quantity of SARS-CoV-2\|Proportion of days with fever after randomization\|Proportion of days with respiratory symptoms after randomization\|FLU-PRO© Plus\|Serious adverse events\|Adverse events resulting in treatment discontinuation\|Adverse events considered related to the investigational products\|LRTI\|Maximum score on WHO Ordinal Scale for Clinical Improvement during study participation\|Cumulative incidence of hospitalization\|Days of hospitalization\|Cumulative incidence of mortality
NCT04530422	Efficacy of Sofosbuvir Plus Ledipasvir in Egyptian Patients With COVID-19 Compared to Standard Treatment	Completed	Phase 3	Apr/15/2020	Jul/23/2020
Alternative id - 14 Interventions - Drug: Sofosbuvir plus Ledipasvir Study type - Interventional Study results - No Results Available Locations - Almaza Military Fever Hospital, Cairo, Egypt Study designs - Allocation: Randomized\|Intervention Model: Parallel Assignment\|Masking: Single (Participant)\|Primary Purpose: Treatment Enrollment - 250 Age - 18 Years to 75 Years (Adult, Older Adult) Outcome measures - Therapeutic success (cured)\|28 days in hospital mortality\|Percentage of clinical failure of treatments\|Length of hospital stay\|Incidence of side effects

Export (.csv)