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
Related questions
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
Read next
What is the best time of day to take Epclusa?
Epclusa can be taken either in the morning or the evening, but it is important to take it at approximately the same time each day. Most people find it easier to take Epclusa in the morning. Continue reading
Does Epclusa cure Hep C, what is the success rate?
Epclusa has a 98% overall cure rate in all 6 of the main types of hepatitis C in patients without cirrhosis (a serious liver disease) or with compensated cirrhosis (mild or no symptoms). Continue reading
How long is an Epclusa treatment?
Epclusa (sofosbuvir and velpatasvir) is given as a single daily pill for 12 weeks duration. With advanced liver disease (decompensated cirrhosis, Child-Pugh B or C), it is combined with ribavirin, also for 12 weeks. If Epclusa is prescribed with ribavirin, follow your doctor’s recommendations for ribavirin dosing. Continue reading
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