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 |
|
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) | |
| |
|
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]
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]
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]
The FDA label for sofosbuvir/velpatasvir/voxilaprevir contains a boxed warning about the risk of Hepatitis B virus reactivation. [2]
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]
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 |
|
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) | |
| |
|
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]
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]
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]
The FDA label for sofosbuvir/velpatasvir/voxilaprevir contains a boxed warning about the risk of Hepatitis B virus reactivation. [2]
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]