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 |
|
| 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) | |
| |
| |
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
Wikiwand in your browser!
Seamless Wikipedia browsing. On steroids.
Every time you click a link to Wikipedia, Wiktionary or Wikiquote in your browser's search results, it will show the modern Wikiwand interface.
Wikiwand extension is a five stars, simple, with minimum permission required to keep your browsing private, safe and transparent.
