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Velpatasvir/sofosbuvir: Difference between revisions

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→‎top: Per Template talk:Infobox drug#Identifiers in boxes for drug combination – hope I did this right (kinetic data also aren't useful for drug combinations)
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| legal_US = Rx-only
| legal_US = Rx-only
| pregnancy_US = B
| pregnancy_US = B

<!--Pharmacokinetic data-->
| bioavailability =
| protein_bound =
| metabolism =
| elimination_half-life =
| excretion =


<!--Identifiers-->
<!--Identifiers-->
| CAS_number =
| QID=Q25110523<!-- v. -->
| QID2=Q25110523<!-- s. -->
| index_comment = velpatasvir
| index2_comment = sofosbuvir
| index_label = v.
| index2_label = s.
| CAS_number = 1377049-84-7
| CAS_number2 = 1190307-88-0
| ATC_prefix =
| ATC_prefix =
| ATC_suffix =
| ATC_suffix =
| ATC_supplemental =
| ATC_supplemental =
| PubChem =
| PubChem = 91885554
| PubChem2 =
| KEGG = D10827
| DrugBank =
| UNII = KCU0C7RS7Z
| UNII2 = WJ6CA3ZU8B
| KEGG2 = D10366
| ChEBI = 133009
| ChEBI2 = 85083
| ChEMBL2 = 1259059
| ChemSpiderID = 34501056
| ChemSpiderID2 = 26286922
}}
}}



Revision as of 15:50, 23 February 2017

Velpatasvir/sofosbuvir
Combination of
VelpatasvirNS5A inhibitor
SofosbuvirNS5B (RNA polymerase) inhibitor
Clinical data
Trade namesEpclusa
AHFS/Drugs.comepclusa
Routes of
administration
Oral
Legal status
Legal status
Identifiers
PubChem CID
KEGG

Velpatasvir/sofosbuvir (trade name Epclusa) is a two-drug combination for the treatment of hepatitis C. It is administered as a single daily pill containing the viral NS5A inhibitor velpatasvir and sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase. A single tablet regimen is used for adults with genotype 1–6 chronic hepatitis C virus (HCV) infection.[1]

Velpatasvir/sofosbuvir was developed by the pharmaceutical company Gilead Sciences and approved by US FDA in June 2016.[2] In the European Union it was approved on 6 July 2016 for the treatment of chronic hepatitis C virus infection in adults.[3]

Contraindications

Combining velpatasvir/sofosbuvir with strong inducers of the liver enzymes CYP2B6, CYP2C8 or CYP3A4, or with P-glycoprotein, is contraindicated because such substances may reduce the effectiveness of the hepatitis C drug.[4]

Side effects

Common side effects (in more than 10% of people) are headache, fatigue and nausea. In studies, severe side effects were experienced in 3% of patients, and 0.2% terminated the therapy because of adverse events. These effects occurred with similar frequencies in people treated with placebo.[4]

Interactions

Pharmacokinetics

History

Beacon Pharmaceuticals, Bangladesh, introduced a generic version product under the trade name of Sofosvel. Beacon got approval from the Directorate of Drug Administration, Ministry of Health and Family Welfare, People's Republic of Bangladesh.[5] Other Indian companies with similar licenses are expected to follow.[6]

References

  1. ^ FDA Approves Epclusa, Drugs.com
  2. ^ "FDA approves Epclusa for treatment of chronic Hepatitis C virus infection". Retrieved 14 July 2016.
  3. ^ http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004210/human_med_001997.jsp&mid=WC0b01ac058001d124
  4. ^ a b Haberfeld, H, ed. (2016). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
  5. ^ US’ Gilead faces competition from Bangladesh’s Beacon pharma, The Economic Times
  6. ^ http://esofosbuvir.com/sofosvel-generic-hepatitis-c-medicine-genotypes/