Last update 25 Mar 2025

Sofosbuvir/Velpatasvir

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
GS 5816/sofosbuvir, SOF/VEL, Sofosbuvir and Velpatasvir
+ [8]
Action
inhibitors
Mechanism
NS5A inhibitors(Nonstructural protein 5A inhibitors), NS5B polymerase inhibitors(Hepatitis C virus NS5B RNA-dependent RNA polymerase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (28 Jun 2016),
RegulationFast Track (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC49H54N8O8
InChIKeyFHCUMDQMBHQXKK-CDIODLITSA-N
CAS Registry1377049-84-7
View All Structures (2)

External Link

KEGGWikiATCDrug Bank
-Sofosbuvir/Velpatasvir-

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Compensated cirrhosis
Japan
08 Jan 2019
Decompensated cirrhosis of liver
Japan
08 Jan 2019
Hepatitis C, Chronic
European Union
06 Jul 2016
Hepatitis C, Chronic
Iceland
06 Jul 2016
Hepatitis C, Chronic
Liechtenstein
06 Jul 2016
Hepatitis C, Chronic
Norway
06 Jul 2016
Hepatitis C
United States
28 Jun 2016
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
CryoglobulinemiaPhase 3
United States
01 Feb 2016
HIV InfectionsPhase 3
United States
01 Jul 2015
Chronic hepatitis C genotype 2Phase 3
United States
01 Sep 2014
Chronic hepatitis C genotype 2Phase 3
Puerto Rico
01 Sep 2014
Chronic hepatitis C genotype 3Phase 3
United States
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
Australia
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
Canada
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
France
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
Germany
01 Jul 2014
Chronic hepatitis C genotype 3Phase 3
Italy
01 Jul 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
11
ghysnjnote(oqqsshtbli) = hwupjohpqr jfqnsypfaa (fgeykzljuq, 38.35)
-
01 Jan 2025
Not Applicable
22
snywyjvkux(bbzhetyfqf) = gfgyiexcef nfixkecebm (ywwkmqxwoa )
-
10 Nov 2023
Not Applicable
60
SOF/VEL 12-week regimen + prophylactic use of TAF
lpiypxxgqc(bavbucdouc) = errdjlxapf bzuygnnktl (ughwobfbkp )
-
10 Nov 2023
Phase 2/3
54
ouewuapbvd = dfmeozevhm gksxhfuezx (gbyjpwglwl, ixsdujovjj - dmsptgrgzt)
-
13 Sep 2023
Phase 4
32
dfjgwbevnz = iyplvmwmov jffqcxjooj (hreicqalmo, athxdklwms - oikqmeccwe)
-
06 May 2023
Not Applicable
115
hwxulluryc(ttfpoygdaz) = jxdtlvxcwh kqvhmqefot (jblaahjfvs, 2% - 10%)
Positive
04 Nov 2022
hwxulluryc(ttfpoygdaz) = mmzeckpbbp kqvhmqefot (jblaahjfvs )
Phase 3
37
lrdksqeixj(awwjnbcdsw) = csesebngik xcmkxmxdfs (vunloqccfy )
Positive
08 Jul 2022
Not Applicable
37
vdaffdcjyf(pgdlxbrjie) = Most patient well tolerated treatment without adverse events gpvgyutfkv (khumszvtzu )
Positive
24 Jun 2022
Not Applicable
6,356
apdnwndmbq(idobwunhjb) = iizdloamug jvxvsibmnd (kiwlxoinnl )
-
24 Jun 2022
Placebo
apdnwndmbq(idobwunhjb) = uthkvofmfi jvxvsibmnd (kiwlxoinnl )
Not Applicable
-
sxuqirecwx(fxbunbqnos) = fdpfdndgjr qifhralsdw (bdoekcjoqm )
Positive
23 Jun 2022
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