Ombitasvir/paritaprevir/ritonavir

Source: Wikipedia, the free encyclopedia.

Ombitasvir/paritaprevir/ritonavir
Combination of
NS3 inhibitor)
RitonavirPK enhancer (CYP3A4, CYP2D6 inhibitor)
Clinical data
Trade namesViekira Pak (with dasabuvir), Technivie, Viekirax, others
AHFS/Drugs.comMonograph
MedlinePlusa615036
License data
Routes of
administration
By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
ChemSpider
  • none
KEGG
ChEBI
  (verify)
Dasabuvir/ombitasvir/paritaprevir/ritonavir
Combination of
NS3 inhibitor)
RitonavirPK enhancer (CYP3A4, CYP2D6 inhibitor)
Clinical data
Trade namesViekira Pak, Viekira XR, Holkira Pak, others
AHFS/Drugs.comMonograph
MedlinePlusa614057
License data
By mouth
ATC code
Legal status
Legal status
Identifiers
PubChem CID
ChemSpider
  • none
KEGG
ChEBI

Ombitasvir/paritaprevir/ritonavir, sold under the brand name Technivie among others, is a medication used to treat

hepatitis C virus genotype 1 or 4.[2][3] Cure rates are around 95%.[3] It is taken by mouth.[2]

It is generally well tolerated.

liver problems.[2] While there is no evidence of harm with use during pregnancy, this use has not been well studied.[2] Each of the medications works by a different mechanism.[3] The ritonavir is present to decrease the breakdown of paritaprevir.[2]

Ombitasvir/paritaprevir/ritonavir with dasabuvir was approved for medical use in the United States in 2014, and without dasabuvir in 2015.[5][6] It is on the World Health Organization's List of Essential Medicines.[7]

Medical uses

Ombitasvir/paritaprevir/ritonavir is used together with

hepatitis C virus genotype 1 or 4.[2][3] Cure rates are around 95%.[3]

Contraindications

Side effects

Post-market surveillance reports show hepatic decompensation and

baseline.[8]

Ombitasvir/paritaprevir/ritonavir could cause hepatitis B re-activation in people co-infected with hepatitis B and C viruses. The European Medicines Agency recommended screening all people for hepatitis B before starting ombitasvir/paritaprevir/ritonavir for hepatitis C in order to minimize the risk of hepatitis B reactivation.[9]

Society and culture

It is manufactured by

Abbvie. In the United States ombitasvir/paritaprevir/ritonavir together with dasabuvir is sold as Viekira Pak.[10] Technivie consists of only ombitasvir/paritaprevir/ritonavir tablets.[11] Technivie was discontinued in the US market in 2020.[12]

Approval

United States

Ombitasvir/paritaprevir/ritonavir together with dasabuvir was approved in its first review cycle by the FDA in December 2014.

Priority Review under the Prescription Drug User Fee Act allowing the review to be completed in six months rather than the standard ten months.[14]

Europe

In Europe, ombitasvir/paritaprevir/ritonavir is approved under the trade name Viekirax for combination therapy together with dasabuvir, with or without ribavirin.[15][16]

Research

Sapphire I

Sapphire I was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (

SVR12) rate in non-cirrhotic patients with HCV GT1a and GT1b - who were new to HCV treatment - and were given Viekira Pak and ribavirin (RBV). Sapphire I reported a 96% cure rate.[17]

Sapphire II

Sapphire II was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1a and GT1b - who had previously received treatment - and were given Viekira Pak and (RBV). SAPPHIRE II reported a 96% cure rate.[17]

Pearl II

Pearl II was a 12-week open-label, randomized trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1b - who had previously received treatment - and were given either Viekira Pak and (RBV) or Viekira Pak alone. Pearl II reported a 100% cure rate.[17]

Pearl III

Pearl III was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1b - who were new to HCV treatment - and were given Viekira Pak and (RBV) or Viekira Pak and a RBV placebo. Pearl III reported a 100% cure rate[17]

Pearl IV

Pearl IV was a 12-week placebo-controlled, randomized, double-blind trial which had a primary endpoint of cure (SVR12) rate in non-cirrhotic patients with HCV GT1b - who were new to HCV treatment - and were given Viekira Pak and (RBV) or Viekira Pak and a RBV placebo. The primary difference between Pearl III and PEARL IV was that PEARL IV had a 1:2 allocation ratio meaning twice as many participants were given Viekira Pak and RBV placebo compared to Viekira Pack and RBV. Pearl IV had a 97% cure rate.[17]

Turquoise II

Turquoise II was an open-label, randomized trial which had a primary endpoint of cure (SVR12) rate in patients with compensated cirrhosis and either HCV GT1a or GT1b and both treatment arms were given Viekira Pak and (RBV). The two treatment arms differed by length of treatment: subjects were randomly assigned to receive treatment for either 12 or 24 weeks. The results were stratified based on whether or not subjects had previously received pegIFN/RBV treatment. This is the only phase III trial which has been completed with Viekira Pak and cirrhotic patients with HCV. TURQUOISE II reported a 95% cure rate for the 24-week arm and 99% cure rate for the 12-week arm. Subjects with genotype 1a had higher cure rates in the 24-week arm than the 12-week arm.[17]

References

  1. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  2. ^ a b c d e f g h i j "Ombitasvir, Paritaprevir, and Ritonavir with Dasabuvir Sodium". The American Society of Health-System Pharmacists. Archived from the original on 1 January 2017. Retrieved 8 December 2016.
  3. ^ a b c d e "Viekirax 12.5 mg/75 mg/50 mg film-coated tablets - Summary of Product Characteristics (SPC) - (eMC)". www.medicines.org.uk. 15 January 2015. Archived from the original on 1 January 2017. Retrieved 31 December 2016.
  4. ISSN 0512-3054
    . WHO technical report series;994.
  5. ^ "Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir (Viekira Pak) - Treatment - Hepatitis C Online". www.hepatitisc.uw.edu. Archived from the original on 1 November 2016. Retrieved 31 December 2016.
  6. ^ "Ombitasvir, Paritaprevir, and Ritonavir". The American Society of Health-System Pharmacists. Archived from the original on 1 January 2017. Retrieved 8 December 2016.
  7. . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  8. ^ a b Commissioner, Office of the. "Safety Information - Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), Copackaged for Oral Use". www.fda.gov. Archived from the original on 17 November 2016. Retrieved 30 November 2015.
  9. ^ "Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)". European Medicines Agency (EMA). 17 September 2018. Retrieved 4 February 2020.
  10. ^ Viekira Pak viekira-pak on Drugs.com.
  11. ^ "Technivie (ombitasvir, paritaprevir and ritonavir) tablets, for oral useInitial U.S. Approval: 2015". DailyMed. 22 January 2020. Retrieved 26 April 2020.
  12. ^ "Technivie: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 April 2020.
  13. ^ "Press Announcements - FDA approves Viekira Pak to treat hepatitis C". www.fda.gov. Archived from the original on 31 October 2015. Retrieved 30 November 2015.
  14. ^ "Novel New Drugs 2014 Summary" (PDF). U.S. Food and Drug Administration (FDA). January 2015. Archived (PDF) from the original on 15 January 2016. Retrieved 30 November 2015.
  15. ^ Haberfeld (ed.). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
  16. ^ "Viekirax EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 26 April 2020.
  17. ^ a b c d e f "Hepatitis C clinical trials program overview" (PDF). Abbvie. Archived (PDF) from the original on 7 September 2015. Retrieved 27 November 2015.

External links