Ombitasvir/paritaprevir/ritonavir
| Combination of | |
|---|---|
| Ombitasvir | Antiviral (NS5A inhibitor) |
| Paritaprevir | Antiviral (NS3 inhibitor) |
| Ritonavir | PK enhancer (CYP3A4, CYP2D6 inhibitor) |
| Clinical data | |
| Trade names | Viekira Pak (with dasabuvir), Technivie, Viekirax, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a615036 |
| License data | |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem SID | |
| ChemSpider |
|
| KEGG | |
| ChEBI | |
| (verify) | |
| Combination of | |
|---|---|
| Dasabuvir | Antiviral |
| Ombitasvir | Antiviral (NS5A inhibitor) |
| Paritaprevir | Antiviral (NS3 inhibitor) |
| Ritonavir | PK enhancer (CYP3A4, CYP2D6 inhibitor) |
| Clinical data | |
| Trade names | Viekira Pak, Viekira XR, Holkira Pak, others |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a614057 |
| License data | |
| Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status |
|
| Identifiers | |
| PubChem CID | |
| ChemSpider |
|
| KEGG | |
| ChEBI | |
Ombitasvir/paritaprevir/ritonavir, sold under the brand name Technivie among others, is a medication used to treat hepatitis C.[2] It is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir.[2] Specifically it is used together with dasabuvir or ribavirin for cases caused by 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.[4] Common side effects include nausea, itchiness, rash, and trouble sleeping.[2] Other side effects include allergic reactions and reactivation of hepatitis B among those previously infected.[2] Use is not recommended in those with significant 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[edit]
Ombitasvir/paritaprevir/ritonavir is used together with dasabuvir or ribavirin for cases caused by hepatitis C virus genotype 1 or 4.[2][3] Cure rates are around 95%.[3]
Contraindications[edit]
- 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[8]
Side effects[edit]
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.[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[edit]
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[edit]
United States[edit]
Ombitasvir/paritaprevir/ritonavir together with dasabuvir was approved in its first review cycle by the FDA in December 2014.[13] 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.[14]
Europe[edit]
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[edit]
Sapphire I[edit]
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[edit]
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[edit]
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[edit]
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[edit]
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[edit]
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[edit]
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ 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.
- ^ 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.
- ^ 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.
- ^ "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.
- ^ "Ombitasvir, Paritaprevir, and Ritonavir". The American Society of Health-System Pharmacists. Archived from the original on 1 January 2017. Retrieved 8 December 2016.
- ^ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl:10665/325771. WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
- ^ 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.
- ^ "Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free)". European Medicines Agency (EMA). 17 September 2018. Retrieved 4 February 2020.
- ^ Viekira Pak viekira-pak on Drugs.com.
- ^ "Technivie (ombitasvir, paritaprevir and ritonavir) tablets, for oral useInitial U.S. Approval: 2015". DailyMed. 22 January 2020. Retrieved 26 April 2020.
- ^ "Technivie: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 April 2020.
- ^ "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.
- ^ "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.
- ^ Haberfeld (ed.). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag.
- ^ "Viekirax EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 26 April 2020.
- ^ 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[edit]
- "Ombitasvir mixture with paritaprevir and ritonavir". Drug Information Portal. U.S. National Library of Medicine.
- "Dasabuvir combination with ombitasvir, paritaprevir and ritonavir". Drug Information Portal. U.S. National Library of Medicine.
- "FDA Drug Safety Communication: FDA warns of serious liver injury risk with hepatitis C treatments Viekira Pak and Technivie". U.S. Food and Drug Administration (FDA). 24 August 2016.
- "FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C". U.S. Food and Drug Administration (FDA). 4 October 2016.
