Breast Cancer Resistance Protein Inhibitors

HCV NS3/4A Protease Inhibitors

Hepatitis C Virus NS3/4A Protease Inhibitor

Hepatitis C Virus NS5A Inhibitor

Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor

Organic Anion Transporting Polypeptide 1B1 Inhibitors

Organic Anion Transporting Polypeptide 1B3 Inhibitors

Organic Anion Transporting Polypeptide 2B1 Inhibitors

P-Glycoprotein Inhibitors

RNA Replicase Inhibitors

Chronic Hepatitis C

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>VOSEVI is a fixed-dose combination tablet containing sofosbuvir, velpatasvir, and voxilaprevir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor, velpatasvir is an NS5A inhibitor, and voxilaprevir is an NS3/4A protease inhibitor.Each tablet contains 400 mg sofosbuvir, 100 mg velpatasvir, and 100 mg of voxilaprevir. The tablets include the following inactive ingredients: colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing the following inactive ingredients: ferrosoferric oxide, iron oxide red, iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>Sofosbuvir: The IUPAC name for sofosbuvir is (S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)-(phenoxy)phosphorylamino)propanoate. It has a molecular formula of C22H29FN3O9P and a molecular weight of 529.45. It has the following structural formula:<img alt="Chemical Structure" src="vosevi-02.jpg"/>Sofosbuvir is a white to off-white crystalline solid with a solubility of at least 2 mg/mL across the pH range of 2–7.7 at 37 °C and is slightly soluble in water.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Velpatasvir: The IUPAC name for velpatasvir is Methyl {(1R)-2-[(2S,4S)-2-(5-{2-[(2S,5S)-1-{(2S)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-5-methylpyrrolidin-2-yl]-1,11-dihydro[2]benzopyrano[4',3':6,7]naphtho[1,2-d]imidazol-9-yl}-1H-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl}carbamate. It has a molecular formula of C49H54N8O8 and a molecular weight of 883.0. It has the following structural formula:<img alt="Chemical Structure" src="vosevi-03.jpg"/>Velpatasvir is practically insoluble (less than 0.1 mg/mL) above pH 5, slightly soluble (3.6 mg/mL) at pH 2, and soluble (greater than 36 mg/mL) at pH 1.2.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>Voxilaprevir: The IUPAC name for voxilaprevir is (1aR,5S,8S,9S,10R,22aR)-5-tert-butyl-N-{(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropanesulfonyl) carbamoyl]cyclopropyl}-9-ethyl-18,18-difluoro-14-methoxy-3,6-dioxo-1,1a,3,4,5,6,9,10,18,19,20,21,22,22a-tetradecahydro-8H-7,10-methanocyclopropa[18,19][1,10,3,6]dioxadiazacyclononadecino[11,12-b]quinoxaline-8-carboxamide. It has a molecular formula of C40H52F4N6O9S and a molecular weight of 868.9. It has the following structural formula:<img alt="Chemical Structure" src="vosevi-04.jpg"/>Voxilaprevir is a white to light brown solid. It is slightly hygroscopic to hygroscopic. Voxilaprevir is practically insoluble (less than 0.1 mg/mL) below pH 6.8.</div></section>

Vosevi

sofosbuvir

sofosbuvir / velpatasvir / voxilaprevir

sofosbuvir 400 MG / velpatasvir 100 MG / voxilaprevir 100 MG Oral Tablet

sofosbuvir 400 MG / velpatasvir 100 MG / voxilaprevir 100 MG Oral Tablet [Vosevi]

Genotype	Patients Previously Treated with an HCV Regimen Containing:	VOSEVI Duration
* In clinical trials, prior NS5A inhibitor experience included daclatasvir, elbasvir, ledipasvir, ombitasvir, or velpatasvir. * In clinical trials, prior treatment experience included sofosbuvir with or without any of the following: peginterferon alfa/ribavirin, ribavirin, HCV NS3/4A protease inhibitor (boceprevir, simeprevir, or telaprevir).
1, 2, 3, 4, 5, or 6	An NS5A inhibitor *	12 weeks
1a or 3	Sofosbuvir without an NS5A inhibitor †	12 weeks

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