Sofosbuvir with velpatasvir and voxilaprevir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sofosbuvir with velpatasvir and voxilaprevir.
Drugs List
Therapeutic Indications
Uses
Hepatitis C - chronic
Dosage
Adults
One tablet, once daily, with food.
Treatment duration
Direct-acting antiviral agent naive patients, without cirrhosis
8 weeks.
Direct-acting antiviral agent naive patients with compensated cirrhosis
12 weeks. 8 weeks may be considered in genotype 3 infected patients.
Direct-acting antiviral agent experienced patients, with compensated cirrhosis or without cirrhosis
12 weeks.
Children
Children aged 12 years and older weighing at least 30kg
One tablet, once daily, with food.
Treatment duration
Direct-acting antiviral agent naive patients, without cirrhosis
8 weeks.
Direct-acting antiviral agent naive patients with compensated cirrhosis
12 weeks. 8 weeks may be considered in genotype 3 infected patients.
Direct-acting antiviral agent experienced patients, with compensated cirrhosis or without cirrhosis
12 weeks.
Additional Dosage Information
Advise patient that if a dose of sofosbuvir with velpatasvir and voxilaprevir is missed, the missed dose should be taken as soon as possible, provided it is within 18 hours of the normal time. If it is more than 18 hours, the patient should be advised to wait and take the next dose at the usual time.
Advise patient that if vomiting occurs within 4 hours of a dose, an additional tablet of sofosbuvir with velpatasvir and voxilaprevir should be taken. No additional dose should be taken if vomiting occurs more than 4 hours after taking a dose.
Contraindications
Children under 12 years
Weight below 30kg
Breastfeeding
Galactosaemia
Hepatic impairment - Child-Pugh score greater than 7
Pregnancy
Precautions and Warnings
Atrioventricular block
Bradyarrhythmia
Diabetes mellitus
Glucose-galactose malabsorption syndrome
Haemodialysis
Hepatitis B
Lactose intolerance
Liver transplant
Renal impairment - glomerular filtration rate below 30ml/minute/1.73m sq
Before initiating treatment for HCV, screen all patients for HBV
Treatment should be started by a doctor experienced in hepatitis management
Contains lactose
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Monitor closely if HIV co-infection
Monitor for and manage hepatitis reactivation during treatment
Reactivation of hepatitis B may occur in chronic carriers
Advise patient not to take St John's wort concurrently
Avoid antacids within 4 hours of dose
Advise patients with diabetes of the increased risk of hypoglycaemia
Patients with diabetes may experience improved glucose control and symptomatic hypoglycaemia following treatment initiation. Monitor blood glucose levels closely, particularly within the first 3 months, and adjust diabetic medication as necessary.
Inform specialist in charge of diabetic care of treatment initiation.
Pregnancy and Lactation
Pregnancy
Sofosbuvir with velpatasvir and voxilaprevir is contraindicated during pregnancy.
The manufacturer does not recommend using sofosbuvir with velpatasvir and voxilaprevir during pregnancy.
At the time of writing there is limited published information regarding the use of sofosbuvir with velpatasvir and voxilaprevir during pregnancy. Animal studies on velpatasvir have identified a potential link to reproductive toxicity, while animal studies on sofosbuvir and voxilaprevir have not indicated direct or indirect harmful effects.
Lactation
Sofosbuvir with velpatasvir and voxilaprevir is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking sofosbuvir with velpatasvir and voxilaprevir.
At the time of writing it is unknown if sofosbuvir, velpatasvir and voxilaprevir are excreted in human breast milk. Available data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk. A risk to the infant cannot be excluded.
Side Effects
Abdominal pain
Angioedema
Decreased appetite
Diarrhoea
Headache
Heart block
Muscle spasm
Myalgia
Nausea
Rash
Serum bilirubin increased
Severe bradycardia
Stevens-Johnson syndrome
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2019
Reference Sources
Summary of Product Characteristics: Vosevi 400mg/100mg/100mg film-coated tablets. Gilead Sciences Ltd. Revised April 2022.
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