Vosevi is a fixed dose combination drug developed by Gilead Sciences, which includes sofosbuvir, velpatasvir, and voxilaprevir. It is a direct antiviral drug (DAA).

1、 Drug name

1. Product Name: Vosevi

2. Common name: Sofosbuvir, Velpatasvir, and andvoxilaprevir Compound Tablets

2、 Indications

Vosevi is suitable for treating adult patients with chronic hepatitis C virus (HCV) infection who do not have cirrhosis or have compensatory cirrhosis (Child Pugh A grade). The specific population is as follows:

1. HCV infected individuals who have previously received a regimen containing NS5A inhibitors and have genotypes 1, 2, 3, 4, 5, or 6.

2. HCV infected individuals who have previously received treatment with sofosbuvir but without NS5A inhibitors, and have genotype 1a or 3..

3、 Specifications and characteristics

1. Specification: Each tablet contains a fixed dose combination of 400mg sofosbuvir, 100mg vapatavir, and 100mg fusiravir.

2. Appearance: beige, capsule shaped, film coated tablets. One side is engraved with "GSI" and the other side is engraved with "3".

4、 Main components

Active ingredients: Sofosbuvir, Velpatasvir, Voxilaprevir.

5、 Usage and dosage

1. Recommended dosage: once daily, one tablet each time, taken orally with meals.

2. Treatment course: The recommended course of treatment is 12 weeks.

6、 Dose adjustment

1. Renal dysfunction: Patients with mild, moderate, or severe renal dysfunction (including end-stage renal disease requiring dialysis) do not require dose adjustment.

2. Liver function injury:

Mild injury (Child Pugh A grade): No dose adjustment required.

Moderate or severe injury (Child Pugh B or C): Not recommended as there is a significant risk of liver decompensation/failure due to increased exposure to famciclovir.

7、 Medication precautions

1. Pre treatment testing: Before starting treatment, all patients must be tested for current or past evidence of hepatitis B virus (HBV) infection (HBsAg and anti HBc testing).

2. Usage: It should be taken with meals to maintain a stable drug concentration.

3. Combined use with antacids: If aluminum or magnesium containing antacids are needed, they should be taken 4 hours before or after taking Vosevi.

4. Leakage treatment: If one dose is missed, it should be replenished as soon as possible; But if the time to take the next dose is very close, the missed dose should be skipped and the next dose should be taken at the regular time. Do not take double the dose at once.

8、 Medication for special populations

1. Pregnant women: There is currently insufficient human data, and animal studies have not shown any adverse developmental effects. It can only be used when it is clearly necessary.

2. Breastfeeding women: It is not yet clear whether it is secreted into breast milk. It is necessary to weigh the pros and cons before deciding whether to breastfeed or discontinue medication.

3. Child patients: Safety and efficacy have not been determined yet.

4. Elderly patients (≥ 65 years old): No overall differences were observed in clinical studies compared to younger patients, and dose adjustment is not necessary.

5. Renal function impairment: see "Dose adjustment" above.

6. Liver function injury: see "Dose adjustment" above. For patients with advanced liver disease (such as portal hypertension) or a history of liver decompensation, close monitoring is necessary.

9、 Adverse reactions

1. The most common adverse reactions (incidence ≥ 10%):

Headache, fatigue, diarrhea, nausea.

2. Serious Warning and Precautions:

Risk of HBV reactivation: HCV/HBV co infected patients have reported HBV reactivation leading to fulminant hepatitis, liver failure, and death after receiving or completing HCV direct antiviral drug treatment.

Risk of liver decompensation/failure: mainly occurs in patients with baseline cirrhosis and moderate or severe liver injury. During the treatment period, clinical and laboratory indicators need to be monitored. If there is evidence of liver decompensation/failure, the medication should be stopped immediately.

Co administration with amiodarone can cause severe symptomatic bradycardia: Co administration may lead to severe bradycardia, especially in patients who are taking beta blockers or have underlying heart disease/advanced liver disease. Not recommended for use together. If there are no alternative treatment options, it is recommended to undergo cardiac monitoring.

Co administration with P-gp and/or medium to potent CYP enzyme inducers: may reduce the blood concentration of Vosevi, leading to reduced efficacy. Not recommended for use together.

10、 Contraindications

Do not use it in combination with rifampicin.

11、 Drug interactions

1. Drugs that cause a decrease in Vosevi concentration (not recommended for combination):

P-glycoprotein inducers and/or medium to potent CYP enzyme inducers: such as St. John's wort, carbamazepine, phenytoin, phenobarbital, rifampicin, rifampicin.

2. Medications that require caution or dosage adjustment when used in combination with Vosevi:

Amiodarone: Not recommended for combination, there is a risk of bradycardia.

Some antiretroviral drugs, such as atazanavir and lopinavir (increasing the concentration of fusivir); Efavirenz (reducing the concentrations of Vepatasvir and Voxilavir); Tenofovir Axetil (increasing the concentration of Tenofovir requires monitoring for nephrotoxicity). The above combinations are not recommended.

3. HMG CoA reductase inhibitors (statins):

Pravastatin: The dosage should not exceed 40mg.

Rosuvastatin: Not recommended for combination use.

Pivastatin: Not recommended for combination.

Atorvastatin, Fluvastatin, Lovastatin, Simvastatin: Combination therapy may increase the risk of myopathy, and it is recommended to use the lowest approved dose.

Immunosuppressant: Cyclosporine (significantly increases the concentration of Voxilavir, not recommended for combination).

Anticoagulants: Dabigatran etexil (increasing the concentration of Dabigatran, clinical monitoring is recommended).

Digoxin: Increase the concentration of digoxin and monitor the therapeutic concentration.

4. Acid inhibitor:

Antacids (containing aluminum/magnesium): should be taken every 4 hours.

H2 receptor antagonists: can be taken simultaneously or intermittently, but the equivalent dose of famotidine should not exceed 40mg twice daily.

Proton pump inhibitor: Omeprazole 20mg can be taken with Vosevi. Other proton pump inhibitors have not been studied.

12、 Storage method

1. The storage temperature is below 30 ° C.

2. Please store in the original packaging bottle (containing desiccant) and keep the bottle cap tightly closed to prevent moisture.

3. Please keep out of reach of children.

Voseviinformation