Sofosbuvir oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of sofosbuvir.
Drugs List
Therapeutic Indications
Uses
Chronic hepatitis C - combination therapy
Chronic hepatitis C in adults and children aged 3 to 18 years, with hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5 or 6.
Dosage
Sofosbuvir should always be used in combination with other medicinal products. Refer to the product information for the products used in combination for additional information.
Dose reduction of sofosbuvir is not recommended. If the other medicinal products used in combination with sofosbuvir are discontinued, sofosbuvir should also be discontinued.
Adults
Chronic Hepatitis C: Genotype 1, 4, 5 or 6
Sofosbuvir 400mg once daily + ribavirin + peginterferon alfa for 12 weeks (treatment may be extended to 24 weeks especially in patients with one or more factors associated with lower response rates to interferon-based therapy)
Or
Sofosbuvir 400mg once daily + ribavirin for 24 weeks. Only for use in patients ineligible or intolerant to peginterferon alfa.
Chronic Hepatitis C: Genotype 2
Sofosbuvir 400mg once daily + ribavirin for 12 weeks (treatment may be extended to 24 weeks especially in patients with one or more factors associated with lower response rates to interferon-based therapy).
Chronic Hepatitis C: Genotype 3
Sofosbuvir 400mg once daily + ribavirin + peginterferon alfa for 12 weeks (treatment may be extended to 24 weeks especially in patients with one or more factors associated with lower response rates to interferon-based therapy)
Or
Sofosbuvir 400mg once daily + ribavirin for 24 weeks
Chronic Hepatitis C: Awaiting liver transplant
Sofosbuvir 400 mg once daily + ribavirin until transplant takes place. Duration of treatment should be guided by assessment of the benefits to the risks.
Chronic Hepatitis C: Liver transplant recipients
Sofosbuvir 400mg once daily + ribavirin for 24 weeks.
Children
Children aged 3 to 18 years
Chronic Hepatitis C: Genotype 2
Body weight 35kg or greater:
Sofosbuvir 400mg once daily + ribavirin for 12 weeks (treatment may be extended to 24 weeks especially in patients with one or more factors associated with lower response rates to interferon-based therapy).
Body weight 17kg to 35kg:
Sofosbuvir 200mg once daily + ribavirin for 12 weeks (treatment may be extended to 24 weeks especially in patients with one or more factors associated with lower response rates to interferon-based therapy).
Body weight less than 17kg:
Sofosbuvir 150mg once daily + ribavirin for 12 weeks (treatment may be extended to 24 weeks especially in patients with one or more factors associated with lower response rates to interferon-based therapy).
Chronic Hepatitis C: Genotype 3
Body weight 35kg or greater:
Sofosbuvir 400mg once daily + ribavirin for 24 weeks.
Body weight 17kg to 35kg:
Sofosbuvir 200mg once daily + ribavirin for 24 weeks.
Body weight less than 17kg:
Sofosbuvir 150mg once daily + ribavirin for 24 weeks.
Additional Dosage Information
Missed dose
Advise patient if vomiting occurs within 2 hours of dosing to take an additional dose. If patient vomits more than 2 hours after taking, no additional dose is needed, the normal dosing regimen can resume.
Advise patient if a dose is missed within 18 hours of the normal time of taking, they are to take the missed dose as soon as possible and to take the next dose as usual. If a dose is missed after 18 hours, then advise the patient to wait and take the next dose at the usual time.
Contraindications
Children under 3 years
Breastfeeding
Pregnancy
Precautions and Warnings
Weight below 17kg
Bradycardia
Decompensated liver disease
Diabetes mellitus
End stage renal disease
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatitis B
Lactose intolerance
Renal impairment - eGFR below 30ml/minute/1.73m sq
Monitor HBV levels during and after treatment in patients with co-infection
Advise ability to drive/operate machinery may be affected by side effects
Before initiating screen all patients for hepatitis B infection
Must be used as part of combination therapy
Not all formulations are suitable for all age groups/body weights
Treatment should be started by a doctor experienced in hepatitis management
Some formulations contain lactose
Advise patient to take with or after food
Diabetic control may need adjustment
Monitor blood glucose closely in patients with diabetes mellitus
Advise patient to inform their physician if dyspnoea/chest pain occur
Reactivation of hepatitis B may occur in chronic carriers
Advise patient not to take St John's wort concurrently
Male & female: Ensure adequate contraception during treatment
Advise patients with diabetes of the increased risk of hypoglycaemia
Take another dose if vomiting occurs within 2 hours
Patients that weigh less than 17kg are not recommended to take tablets.
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 is contraindicated during pregnancy.
The manufacturer advises it is preferable to avoid sofosbuvir during pregnancy. Animal studies have not shown any effects on foetal development.
Combination therapy with ribavirin:
Sofosbuvir is only licensed in combination with ribavirin which is a known teratogen, therefore sofosbuvir in combination with ribavirin is contraindicated during pregnancy (see ribavirin information).
Lactation
Sofosbuvir is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking sofosbuvir as the risk to nursing infants cannot be excluded. Animal data reports that sofosbuvir is excreted in breast milk, however the presence in human breast milk is unknown.
Counselling
Advise patients that sofosbuvir granules can be taken shortly before food, shortly after food or with food.
Advise patients that the granules can be taken directly into the mouth and swallowed. Patients should be instructed to swallow the entire contents without chewing. To help with swallowing the patient may use food or water.
Advise patients to sprinkle the granules on one or more spoonfuls of non-acidic soft food (chocolate syrup, mashed potato, ice cream) at or below room temperature. Patients should be instructed to take the granules within 30 minutes of mixing with food and to swallow the entire contents without chewing to avoid a bitter taste.
Advise patients that the granules can be taken directly into the mouth and swallowed with water.
Side Effects
Abdominal discomfort
Agitation
Alopecia
Anaemia
Anxiety
Arthralgia
Asthenia
Attention disturbances
Back pain
Blurred vision
Bradycardia
Chest pain
Chills
Constipation
Cough
Decreased appetite
Depression
Diarrhoea
Dizziness
Dry mouth
Dry skin
Dyspepsia
Dyspnoea
Fatigue
Gastroesophageal reflux
Haemoglobin decrease
Headache
Heart block
Influenza-like symptoms
Insomnia
Irritability
Lymphocytopenia
Memory disturbances
Migraine
Muscle spasm
Myalgia
Nasopharyngitis
Nausea
Neutropenia
Pain
Pruritus
Pyrexia
Rash
Reduced platelet count
Serum bilirubin increased
Stevens-Johnson syndrome
Vomiting
Weight loss
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: December 2020
Reference Sources
Summary of Product Characteristics: Sovaldi 150mg and 200mg coated granules. Gilead Sciences Ltd. Revised November 2021.
Summary of Product Characteristics: Sovaldi 200mg and 400mg film-coated tablets. Gilead Sciences Ltd. Revised November 2021.
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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