Glecaprevir/pibrentasvir
| Combination of | |
|---|---|
| Glecaprevir | NS3/NS4A inhibitor |
| Pibrentasvir | NS5A inhibitor |
| Clinical data | |
| Trade names | Mavyret (US), Maviret (EU) |
AHFS/Drugs.com | mavyret |
| Routes of administration | Oral tablets |
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Glecaprevir/pibrentasvir (trade name Mavyret in the US and Maviret in Europe) is a combination drug containing glecaprevir (100 mg) and pibrentasvir (40 mg). In the United States, it was approved by the Food and Drug Administration in August 2017 for treatment of hepatitis C.[1] In Europe, it was also approved in August 2017 for the same indication.[2] In the United States, a treatment course of Mavyret costs about $26,400 before discounts.[3]
Contents
1 Medical uses
2 Side effects
3 Clinical trials
4 Development
5 References
Medical uses
Mavyret is the brand name a combination drug consisting of the two viral protein inhibitors, glecaprevir and pibrentasvir. Glecaprevir inhibits NS3/4A, a serine protease, and pibrentasvir inhibits NS5A, a zinc-binding hydrophilic phosphoprotein. Both of these proteins are essential in hepatitis C viral RNA replication, which can no longer take place upon inhibition of these proteins.[4]
Mavyret has been approved for the treatment of adults with chronic hepatitis C virus (HCV) genotypes 1-6 with no or mild cirrhosis, who have previously been treated with a NS5A inhibitor or a NS3/4A inhibitor but not both.[1]
Side effects
The only known side effects of glecaprevir/pibrentasvir are hepatitis B reactivation, and more commonly headache, nausea, tiredness, and diarrhea.[4]
Clinical trials
During clinical trials, glecaprevir/pibrentasvir was shown to be effective at clearing all six genotypes of HCV from the blood. Over the course of eight studies involving greater than 2,300 patients with hepatitis C, 99% of non-cirrhotic patients with genotype 1 were negative for HCV after the 8-week treatment regimen. 97% of cirrhotic patients from the same group tested negative for HCV on a 12-week treatment regimen and the results were reportedly similar for the treatment of genotypes 2 and 4-6, whereas 95% of patients with genotype 3 HCV tested negative for the virus after treatment.[4]
Development
The development of glecaprevir/pibrenasvir as a combination treatment was done by AbbVie, Inc. and is in accordance with current GMP standards, per the FDA.[4]
Initial identification of glecaprevir was done in a joint effort by AbbVie, Inc. and Enanta Pharmaceuticals.[5] Enanta had a Collaborative Development and License Agreement with AbbVie for the identification and development of paritaprevir and glecaprevir, two HCV NS3 and NS3/4A protease inhibitors, that lasted from October 2016 to June 2017. In this agreement, Enanta received a total of $427,000 USD in the form of license payments, proceeds from a sale of preferred stock, research funding payments, milestone payments, and royalties.[6]
The identification and development of pibrentasvir was done by AbbVie.[7]
References
^ ab "FDA approves Mavyret for Hepatitis C" (Press release). Food and Drug Administration. 2017-08-03..mw-parser-output cite.citationfont-style:inherit.mw-parser-output .citation qquotes:"""""""'""'".mw-parser-output .citation .cs1-lock-free abackground:url("//upload.wikimedia.org/wikipedia/commons/thumb/6/65/Lock-green.svg/9px-Lock-green.svg.png")no-repeat;background-position:right .1em center.mw-parser-output .citation .cs1-lock-limited a,.mw-parser-output .citation .cs1-lock-registration abackground:url("//upload.wikimedia.org/wikipedia/commons/thumb/d/d6/Lock-gray-alt-2.svg/9px-Lock-gray-alt-2.svg.png")no-repeat;background-position:right .1em center.mw-parser-output .citation .cs1-lock-subscription abackground:url("//upload.wikimedia.org/wikipedia/commons/thumb/a/aa/Lock-red-alt-2.svg/9px-Lock-red-alt-2.svg.png")no-repeat;background-position:right .1em center.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registrationcolor:#555.mw-parser-output .cs1-subscription span,.mw-parser-output .cs1-registration spanborder-bottom:1px dotted;cursor:help.mw-parser-output .cs1-ws-icon abackground:url("//upload.wikimedia.org/wikipedia/commons/thumb/4/4c/Wikisource-logo.svg/12px-Wikisource-logo.svg.png")no-repeat;background-position:right .1em center.mw-parser-output code.cs1-codecolor:inherit;background:inherit;border:inherit;padding:inherit.mw-parser-output .cs1-hidden-errordisplay:none;font-size:100%.mw-parser-output .cs1-visible-errorfont-size:100%.mw-parser-output .cs1-maintdisplay:none;color:#33aa33;margin-left:0.3em.mw-parser-output .cs1-subscription,.mw-parser-output .cs1-registration,.mw-parser-output .cs1-formatfont-size:95%.mw-parser-output .cs1-kern-left,.mw-parser-output .cs1-kern-wl-leftpadding-left:0.2em.mw-parser-output .cs1-kern-right,.mw-parser-output .cs1-kern-wl-rightpadding-right:0.2em
^ "Maviret: EPAR – Summary for the public" (PDF). European Medicines Agency. 2017-08-17.
^ Margolies, Dan. "Kansas agrees to cover drug costs for chronic hepatitis C patients". The Hutchinson News. Retrieved 2018-12-11.
^ abcd "Drugs@FDA: FDA Approved Drug Products". www.accessdata.fda.gov. Retrieved 2017-10-31.
^ Lawitz, Eric J.; O'Riordan, William D.; Asatryan, Armen; Freilich, Bradley L.; Box, Terry D.; Overcash, J. Scott; Lovell, Sandra; Ng, Teresa I.; Liu, Wei (2015-12-28). "Potent Antiviral Activities of the Direct-Acting Antivirals ABT-493 and ABT-530 with Three-Day Monotherapy for Hepatitis C Virus Genotype 1 Infection". Antimicrobial Agents and Chemotherapy. 60 (3): 1546–1555. doi:10.1128/AAC.02264-15. ISSN 1098-6596. PMC 4775945. PMID 26711747.
^ "enta-10q_20170630.htm". www.sec.gov. Retrieved 2017-11-01.
^ Ng, Teresa I.; Krishnan, Preethi; Pilot-Matias, Tami; Kati, Warren; Schnell, Gretja; Beyer, Jill; Reisch, Thomas; Lu, Liangjun; Dekhtyar, Tatyana (May 2017). "In Vitro Antiviral Activity and Resistance Profile of the Next-Generation Hepatitis C Virus NS5A Inhibitor Pibrentasvir". Antimicrobial Agents and Chemotherapy. 61 (5). doi:10.1128/AAC.02558-16. ISSN 1098-6596. PMC 5404558. PMID 28193664.
