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Ombitasvir/paritaprevir/ritonavir

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Ombitasvir/paritaprevir/ritonavir
Combination of
OmbitasvirAntiviral (NS5A inhibitor)
ParitaprevirAntiviral (NS3 inhibitor)
RitonavirPK enhancer (CYP3A4, CYP2D6 inhibitor)
Clinical data
Trade namesTechnivie, Viekirax, others
AHFS/Drugs.comMonograph
MedlinePlusa615036
License data
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
ChemSpider
  • none
KEGG
ChEBI
  (verify)
Dasabuvir/ombitasvir/paritaprevir/ritonavir
Combination of
DasabuvirAntiviral
OmbitasvirAntiviral (NS5A inhibitor)
ParitaprevirAntiviral (NS3 inhibitor)
RitonavirPK enhancer (CYP3A4, CYP2D6 inhibitor)
Clinical data
Trade namesViekira Pak, Viekira XR, Holkira Pak, others
AHFS/Drugs.comMonograph
MedlinePlusa614057
License data
Routes of
administration		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.[6] It is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir.[6] Specifically it is used together with dasabuvir or ribavirin for cases caused by hepatitis C virus genotype 1 or 4.[6][7] Cure rates are around 95%.[7] It is taken by mouth.[6]

It is generally well tolerated.[8] Common side effects include nausea, itchiness, rash, and trouble sleeping.[6] Other side effects include allergic reactions and reactivation of hepatitis B among those previously infected.[6] Use is not recommended in those with significant liver problems.[6] While there is no evidence of harm with use during pregnancy, this use has not been well studied.[6] Each of the medications works by a different mechanism.[7] The ritonavir is present to decrease the breakdown of paritaprevir.[6]

Ombitasvir/paritaprevir/ritonavir with dasabuvir was approved for medical use in the United States in December 2014,[9] without dasabuvir in July 2015,[2][10] and as extended release in July 2016.[11][12][13] It is on the World Health Organization's List of Essential Medicines.[14]

Medical uses

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Ombitasvir/paritaprevir/ritonavir is used together with dasabuvir or ribavirin for cases caused by hepatitis C virus genotype 1 or 4.[6][7] Cure rates are around 95%.[7]

Contraindications

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  • People with moderate to severe liver impairment[citation needed]
  • Concurrent use of moderate to strong inducers of CYP3A and strong inducers of CYP2C8 reduce efficacy[15]

Side effects

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Post-market surveillance reports show hepatic decompensation and hepatic failure associated with Viekira Pak use. It is likely that most patients who experienced this had advanced cirrhosis prior to treatment initiation. Hepatic decompensation is described by rising bilirubin without ALT elevations alongside clinical symptoms such as ascites and hepatic encephalopathy. Patients should be monitored for signs of hepatic decompensation and bilirubin levels should be tested in the first four weeks of treatment and compared to baseline.[15]

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.[16]

Society and culture

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It is manufactured by Abbvie. In the United States ombitasvir/paritaprevir/ritonavir together with dasabuvir is sold as Viekira Pak.[17] Technivie consists of only ombitasvir/paritaprevir/ritonavir tablets.[18] Technivie was discontinued in the US market in 2020.[19]

Approval

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United States

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Ombitasvir/paritaprevir/ritonavir together with dasabuvir was approved in its first review cycle by the FDA in December 2014.[20] The Center for Drug Evaluation and Research (CDER) designated the product for Fast Track because it had potential to treat unmet medical need. This track allows the CDER to view certain information ahead of a completed NDA to cut down the time to approval. Additionally, it was designated Breakthrough Therapy for its substantial improvement in the primary endpoint SVR12 and given Priority Review under the Prescription Drug User Fee Act allowing the review to be completed in six months rather than the standard ten months.[21]

European Union

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In the European Union, ombitasvir/paritaprevir/ritonavir is approved under the brand name Viekirax for combination therapy together with dasabuvir, with or without ribavirin.[3][22]

Research

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Sapphire I

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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.[23]

Sapphire II

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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.[23]

Pearl II

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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.[23]

Pearl III

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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[23]

Pearl IV

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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.[23]

Turquoise II

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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.[23]

References

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  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 "Technivie (ombitasvir, paritaprevir and ritonavir) tablets, for oral useInitial U.S. Approval: 2015". DailyMed. Retrieved 21 September 2024.
  3. ^ a b "Viekirax EPAR". European Medicines Agency (EMA). 9 March 2015. Retrieved 26 April 2020.
  4. ^ "Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets), co-packaged for oral use Initial U.S. Approval: 2014". DailyMed. Retrieved 21 September 2024.
  5. ^ "Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets, for oral useInitial U.S. Approval: 2014". DailyMed. Retrieved 21 September 2024.
  6. ^ 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.
  7. ^ 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.
  8. ^ World Health Organization (2015). The selection and use of essential medicines. Twentieth report of the WHO Expert Committee 2015 (including 19th WHO Model List of Essential Medicines and 5th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization. pp. 70–4. hdl:10665/189763. ISBN 9789241209946. ISSN 0512-3054. WHO technical report series;994.
  9. ^ "Drug Approval Package: Viekira Pak (ombitasvir, paritaprevir, and ritonavir) Tablets NDA #206619". U.S. Food and Drug Administration (FDA). 23 January 2015. Retrieved 21 September 2024.
  10. ^ "Technivie (ombitasvir, paritaprevir, and ritonavir) tablets NDA #207931". U.S. Food and Drug Administration (FDA). 12 May 2016. Retrieved 21 September 2024.
  11. ^ "Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) Extended Release Tablets NDA #208624". U.S. Food and Drug Administration (FDA). 28 June 2017. Retrieved 21 September 2024.
  12. ^ "Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir (Viekira Pak) - Treatment - Hepatitis C Online". Hepatitis C Online. Archived from the original on 1 November 2016. Retrieved 31 December 2016.
  13. ^ "Ombitasvir, Paritaprevir, and Ritonavir". The American Society of Health-System Pharmacists. Archived from the original on 1 January 2017. Retrieved 8 December 2016.
  14. ^ World Health Organization (2023). The selection and use of essential medicines 2023: web annex A: World Health Organization model list of essential medicines: 23rd list (2023). Geneva: World Health Organization. hdl:10665/371090. WHO/MHP/HPS/EML/2023.02.
  15. ^ a b Commissioner Oo. "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.
  16. ^ "Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)". European Medicines Agency (EMA). 9 March 2017. Retrieved 4 February 2020.
  17. ^ Viekira Pak viekira-pak on Drugs.com.
  18. ^ "Technivie (ombitasvir, paritaprevir and ritonavir) tablets, for oral useInitial U.S. Approval: 2015". DailyMed. 22 January 2020. Retrieved 26 April 2020.
  19. ^ "Technivie: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 April 2020.
  20. ^ "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.
  21. ^ "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.
  22. ^ Haberfeld (ed.). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
  23. ^ 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.
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