What are the new drugs for the treatment of hepatitis C?
The newest drugs for the treatment of hepatitis C include Mavyret (glecaprevir and pibrentasvir), Vosevi (sofosbuvir, velpatasvir, and voxilaprevir), and Epclusa (sofosbuvir and velpatasvir).
Mavyret, Vosevi, and Epclusa are all FDA-approved for the treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).
- Mavyret is used to treat patients 3 years of age and older. Mavyret is also approved for patients 3 years and older with HCV genotype 1 infection, who have previously been treated with an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.
- Vosevi is indicated for use in the treatment of adult patients. It is used as a re-treatment option in patients who have been previously treated with an NS5A inhibitor-containing regimen (GT1-6), or a regimen containing sofosbuvir without an NS5A inhibitor (GT1a or GT3).
- Epclusa is approved for use in adults and children 3 years of age and older. Epclusa is also approved in adults and children 3 years of age and older for the treatment of HCV genotype 1, 2, 3, 4, 5 or 6 in patients with decompensated cirrhosis (for use in combination with ribavirin).
Latest FDA Approvals for Hepatitis C
| Drug | Type | Dosage Form | Company | Hepatitis C Indications | Patient Population |
|---|---|---|---|---|---|
|
Mavyret (glecaprevir and pibrentasvir) FDA Approved 2017 |
glecaprevir NS3/4A protease inhibitor pibrentasvir NS5A inhibitor |
tablets, pellets (children 3 to less than 12 years old weighing less than 45 kg) | AbbVie Inc. | genotypes 1,2,3,4,5,6 | adults and children 3 years of age and older |
|
Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) FDA Approved 2017 |
sofosbuvir nucleotide analog NS5B polymerase inhibitor velpatasvir NS5A inhibitor voxilaprevir NS3/4A protease inhibitor |
tablets | Gilead Sciences, Inc. | genotypes 1,2,3,4,5,6 | adults |
|
Epclusa (sofosbuvir and velpatasvir) FDA Approved 2016 |
sofosbuvir nucleotide analog NS5B polymerase inhibitor velpatasvir NS5A inhibitor |
tablets; oral pellets (for children less than 6 years old) | Gilead Sciences, Inc. | genotypes 1,2,3,4,5,6 | adults and children 3 years of age and older |
|
Zepatier (elbasvir and grazoprevir) FDA Approved 2016 |
elbasvir NS5A inhibitor grazoprevir NS3/4A protease inhibitor |
tablets | Merck | genotypes 1 or 4; is used with ribavirin in certain patient populations | adults and children 12 years of age and older or weighing at least 66 lb (30 kg) |
|
Harvoni (ledipasvir and sofosbuvir) FDA Approved 2014 |
ledipasvir NS5A inhibitor sofosbuvir nucleotide analog NS5B polymerase inhibitor |
tablets and oral pellets | Gilead Sciences, Inc. | genotypes 1, 4, 5 or 6; is used with ribavirin in certain patient populations | adults and children 3 years and older |
|
Sovaldi (sofosbuvir) FDA Approved 2013 |
sofosbuvir nucleotide analog NS5B polymerase inhibitor |
tablets and oral pellets | Gilead Sciences, Inc. | genotypes 1, 2, 3 or 4; must be given in combination with other antiviral medications (ribavirin; peginterferon alfa) | adults (type 1-4) and children 3 years and older (type 2-3) |
| Discontinued Products | |||||
|
Viekira XR, Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) FDA Approved 2016 (discontinued) |
dasabuvir non-nucleoside NS5B palm polymerase inhibitor ombitasvir NS5A inhibitor paritaprevir NS3/4A protease inhibitor ritonavir CYP3A inhibitor |
extended release tablets; tablets (co-packaged) |
AbbVie Inc. |
genotypes 1a or 1b |
adults |
|
Daklinza (daclatasvir) FDA Approved 2015 |
daclatasvir NS5A inhibitor |
tablets | BMS | genotypes 1 or 3 | adults |
|
Technivie (ombitasvir, paritaprevir, and ritonavir) FDA Approved 2015 |
ombitasvir NS5A inhibitor paritaprevir NS3/4A protease inhibitor ritonavir CYP3A inhibitor |
tablets | AbbVie Inc. | genotype 4 | adults |
|
Olysio (simeprevir) FDA Approved 2013 |
simeprevir NS3/4A protease inhibitor |
capsules | Janssen Pharmaceuticals, Inc. | genotypes 1 or 4 | adults |
|
Incivek (telaprevir) FDA Approved 2011 (discontinued) |
telaprevir NS3/4A protease inhibitor |
tablets | Vertex Pharmaceuticals Inc. | genotype 1 | adults |
|
Victrelis (boceprevir) FDA Approved 2011 |
boceprevir NS3/4A protease inhibitor |
capsules | Merck | genotype 1 | adults |
For more information, see Oral Hepatitis C Treatments: The Evolving Landscape
References
- Zepatier prescribing information. Updated 12/2021. Merck. Whitehouse Station, NJ. Drugs@FDA. Accessed Feb. 23, 2022 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208261s007lbl.pdf
- Mavyret (glecaprevir and pibrentasvir) [product information]. AbbVie Inc., North Chicago, IL. Accessed Sept. 10, 2021 at https://www.rxabbvie.com/pdf/mavyret_pi.pdf
- Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) [product information]. Gilead Sciences Inc., Foster City, CA. Updated 11/2019. Accessed Feb. 11, 2021 at https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/vosevi/vosevi_pi.pdf
- Epclusa (sofosbuvir and velpatasvir). [product information]. Gilead Sciences Inc., Foster City, CA. Updated 07/2020. Accessed June 14, 2021 at https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/epclusa/epclusa_pi.pdf
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