Sofosbuvir/velpatasvir/voxilaprevir, sold under the brand name Vosevi, is a fixed-dose combination medication for the treatment of hepatitis C. It contains sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor; velpatasvir, an HCV NS5A inhibitor; and voxilaprevir an HCV NS3/4A protease inhibitor.[2][5]
Combination of | |
---|---|
Sofosbuvir | NS5B RNA polymerase inhibitor |
Velpatasvir | NS5A inhibitor |
Voxilaprevir | NS3/4A protease inhibitor |
Clinical data | |
Trade names | Vosevi |
AHFS/Drugs.com | Monograph |
MedlinePlus | a617037 |
License data | |
Pregnancy category |
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Routes of administration | By mouth (tablets) |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
PubChem CID | |
KEGG | |
Chemical and physical data | |
Formula | C111H135F5N17O26PS |
Molar mass | 2281.42 g·mol−1 |
3D model (JSmol) | |
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The most common adverse reactions include headache, fatigue, diarrhea, and nausea.[6]
The combination was approved for medical use in the United States and in the European Union in July 2017.[6][3] Vosevi is sold by Gilead Sciences.[6]
Medical uses
In the US, sofosbuvir/velpatasvir/voxilaprevir is indicated for the treatment of adults with chronic hepatitis C virus infection without cirrhosis (liver disease) or with compensated cirrhosis (Child-Pugh A).[2][6]
In the EU, it is indicated for the treatment of chronic hepatitis C virus infection in people aged twelve years of aged and older and weighing at least 30 kilograms (66 lb).[3][4]
Adverse effects
The FDA label for sofosbuvir/velpatasvir/voxilaprevir contains a boxed warning about the risk of Hepatitis B virus reactivation.[2]
History
The safety and efficacy of sofosbuvir/velpatasvir/voxilaprevir was evaluated in two phase III clinical trials that enrolled approximately 750 adults without cirrhosis or with mild cirrhosis.[6] The first trial compared twelve weeks of treatment with the combination versus treatment with placebo in adults with genotype 1 who had previously failed treatment with an NS5A inhibitor drug.[6] Participants with genotypes 2, 3, 4, 5, or 6 all received the combination.[6] The second trial compared twelve weeks of treatment with the combination versus treatment with the previously approved drugs sofosbuvir and velpatasvir in adults with genotypes 1, 2, or 3 who had previously failed treatment with sofosbuvir but not an NS5A inhibitor drug.[6] Results of both trials demonstrated that 96-97 percent of participants who received the combination had no virus detected in the blood 12 weeks after finishing treatment, suggesting that participants’ infection had been cured.[6]
The US Food and Drug Administration (FDA) granted the application for sofosbuvir/velpatasvir/voxilaprevir priority review and breakthrough therapy designations.[6] The FDA granted approval of Vosevi to Gilead Sciences Inc.[6]
References
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