Sofosbuvir with velpatasvir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sofosbuvir with velpatasvir.
Drugs List
Therapeutic Indications
Uses
Hepatitis C - chronic
Dosage
Adults
One 400mg/100mg tablet once a day.
Patients without cirrhosis and patients with compensated cirrhosis
Treat for 12 weeks.
Consider adding ribavirin to regime for genotype 3 infected patients with compensated cirrhosis.
Patients with decompensated cirrhosis
Sofosbuvir with velpatasvir plus ribavirin for 12 weeks.
Patients who have previously failed therapy with NS5A-containing therapy
Consider sofosbuvir with velpatasvir plus ribavirin for 24 weeks.
At the time of writing, there are no data to support efficacy of treatment in these patients. The suggested treatment length has come from NS5A resistance associated variants seen typically in other NS5A inhibitor regimes which have failed, the in vitro pharmacology of velpatasvir, and ASTRAL-studies in NS5A-naive patients with baseline NS5A resistance associated variants treated with sofosbuvir with velpatasvir.
See product literature for dosing information of ribavirin.
Children
Children aged 6 to 18 years weighing at least 17kg
Children 17kg to 30kg: One 200mg/50mg tablet once a day
Children 30kg or above: One 400mg/100mg tablet or two 200mg/50mg tablets once a day
Treat for 12 weeks.
Additional Dosage Information
Advise patient if a dose is missed within 18 hours of when it would normally have been taken to take the tablet as soon as possible and resume normal dosing schedule. If more than 18 hours have passed, the patient should wait and take the next dose at the usual time. Avoid double dosing.
Advise patient if vomiting occurs within 3 hours of taking sofosbuvir with velpatasvir, another tablet should be taken. If more than 3 hours have passed, no additional dose is needed.
Contraindications
Children under 6 years
Weight below 17kg
Breastfeeding
Pregnancy
Precautions and Warnings
Diabetes mellitus
End stage renal disease
Hepatitis B
Liver transplant
Renal impairment - eGFR below 30ml/minute/1.73m sq
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Monitor HBV levels during and after treatment in patients with co-infection
Before initiating screen all patients for hepatitis B infection
Not all available products are licensed for all age groups
Treatment should be started by a doctor experienced in hepatitis management
Advise patient on concurrent use of proton pump inhibitors
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Reactivation of hepatitis B may occur in chronic carriers
Advise patient not to take St John's wort concurrently
Avoid antacids and mineral supplements within 4 hours of dose
Advise patients with diabetes of the increased risk of hypoglycaemia
Take another dose if vomiting occurs within 3 hours
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.
Sofosbuvir with velpatasvir may be used with no dosage adjustment in patients with severe renal impairment and end stage renal disease requiring haemodialysis if no other treatments are available.
Pregnancy and Lactation
Pregnancy
Sofosbuvir with velpatasvir is contraindicated in pregnancy.
The manufacturer suggests, as a precautionary measure sofosbuvir with velpatasvir is not recommended in pregnancy.
Lactation
Sofosbuvir with velpatasvir is contraindicated in breastfeeding.
At the time of writing, it is unknown if sofosbuvir or velpatasvir are excreted in human milk. Available data in animals have shown excretion of velpatasvir and metabolites of sofosbuvir in milk. Risk to the infant cannot be excluded.
Side Effects
Angioedema
Decrease in haemoglobin
Fatigue
Headache
Heart block
Nausea
Rash
Severe bradycardia
Stevens-Johnson syndrome
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: Epclusa 400mg/100mg film-coated tablets. Gilead Sciences International Ltd. Revised January 2021.
Summary of Product Characteristics: Epclusa 200mg/50mg film-coated tablets. Gilead Sciences International Ltd. Revised January 2021.
PRAC warns of risk of hepatitis B re-activation with direct-acting antivirals for hepatitis C. Available at: https://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2016/12/WC500217496.pdf
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