Vosevi Instructions
Common name: Vosevi
Trade name: Vosevi
All names: Vosevi, Gilead IV, Vosevi, sofosvivo tablets, Vosevi, sofosbuvir, velpatasvir, voseprevir, sofosbuvir, velpatasvir, voxilaprevir
Indications:
For the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis (Child-Pugh A) who are:
·Infected with genotype 1, 2, 3, 4, 5, or 6 and have previously received an HCV regimen containing an NS5A inhibitor.
·Genotype 1a or 3 infection and previous HCV treatment regimen containing sofosbuvir without an NS5A inhibitor.
Usage and dosage:
Recommended dosage:
Take orally, one tablet each time, with food, once a day for 12 weeks.
Adverse Reactions:
Get medical help right away if you have signs of allergy to GIV: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
In rare cases, GIS can cause severe liver damage. Contact your doctor immediately if you have any of the following symptoms:
Pain in the right upper quadrant;
Nausea, vomiting, loss of appetite;
Confusion, fatigue, dizziness;
Easy bruising or bleeding, vomiting blood;
Diarrhea, dark or bloody stools;
Dark urine;
Yellow skin or eyes. If you take the heart rhythm drug amiodarone at the same time: Taking amiodarone and GIV at the same time can cause dangerous heart side effects. If you are taking these medicines and have any of the following symptoms, contact your doctor immediately:
Slow heartbeat, chest pain, shortness of breath;
Confusion, memory problems;
Weakness, extreme fatigue, dizziness.
Others include:
Headache;
Feeling tired;
Nausea, diarrhea.
Taboos:
It is prohibited to use GIV and rifampin at the same time.
Precautions:
Risk of hepatitis B virus reactivation in patients co-infected with HCV and HBV
Risk of hepatic decompensation/failure in patients with advanced liver disease
When used in combination with amiodarone, Severe symptomatic bradycardia
Risk of reduced efficacy when used concomitantly with P-gp inducers and/or moderate to strong CYP inducers
Storage:
Store below 30°C (86°F). Only distributed in the original container.
Mechanism of action:
The fourth generation of GIS is a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir, which are all DAA preparations against hepatitis C virus. Sofosbuvir is an inhibitor of HCV NS5B RNA-dependent RNA polymerase, which is required for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form a pharmacologically active uridine triphosphate analog (GS-461203), which can be incorporated into HCV RNA through NS5B polymerase to terminate the chain. Velpatasvir is an inhibitor of the HCV NS5A protein, which is required for viral replication. Resistance selection in cell culture and cross-resistance experiments showed that velpatasvir's mechanism of action targets NS5A.
Voseprevir is a non-covalent, reversible inhibitor of the NS3/4A protease, which is required for the proteolytic cleavage of the HCV-encoded polyprotein into the mature forms of the NS3, NS4A, NS4B, NS5A and NS5B proteins and is critical for viral replication.
Safety and efficacy:
The two phase 3 trials of POLARIS-1 and POLARIS-4 confirmed the efficacy of GIV. Sustained virological response (SVR12) was the primary endpoint of both trials and was defined as HCV RNA falling below the lower limit of quantification 12 weeks after stopping treatment.
POLARIS-1 was a randomized, double-blind, placebo-controlled trial that evaluated the difference between 12 weeks of treatment with GIV versus 12 weeks of placebo in DAA-experienced subjects infected with HCV genotypes 1, 2, 3, 4, 5, or 6, without cirrhosis or with compensated cirrhosis, and who were refractory to NS5A inhibitor-containing therapy.
In the POLARIS-1 trial, the SVR12 achievement rates for HCV genotypes 1, 2, 3, 4, 5, and 6 in the fourth generation group were: 97%, 100%, 95%, 91%, 100%, 100% respectively, and the overall achievement rate was 96%. None of the placebo groups reached SVR12.
POLARIS-4 was a randomized, open-label trial that evaluated the difference between 12 weeks of sofosbuvir/velpatasvir and 12 weeks of sofosbuvir/velpatasvir in patients with genotype 1, 2, 3, or 4 HCV infection without cirrhosis or with compensated cirrhosis who were refractory to HCV DAA-containing, non-NS5A inhibitor-containing therapies.
The trial results of POLARIS-4 show that in HCV genotype 1a and 3 infections, the fourth generation of Gizumab achieves a higher SVR12 achievement rate than sofosbuvir/velpatasvir; in HCV genotype 1b and 2 infections, the SVR12 achievement rates of the two therapies are similar; in HCV genotype 4, 5 and 6 infections, there is no comparative data.
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