omeprazole 20 mg; take 4 hours after sofosbuvir with
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y mg sofosbuvir/velpatasvir.
l CAUTIONS Hepatitis B co-infection
l INTERACTIONS → Appendix 1: sofosbuvir. velpatasvir
l SIDE-EFFECTS Atrioventricular block . bradycardia . fatigue . headache . nausea
Vomiting Manufacturer advises if vomiting occurs within
3 hours of administration, an additional dose should be
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Sofosbuvir–velpatasvir for treating chronic hepatitis C
Sofosbuvir with velpatasvir is recommended as an option
for treating chronic hepatitis C infection in adults, if the
. of genotype 1, 3, 4, 5 or 6 with or without cirrhosis
(previously treated or treatment naive patients);
. of genotype 2 with cirrhosis (previously treated or
. of genotype 2 without cirrhosis (treatment naive
patients), only if interferon not suitable or not tolerated,
or without cirrhosis (previously treated patients).
This is contingent on the manufacturer providing the drug
with the discount agreed in the simple discount
Patients whose treatment was started within the NHS
before this guidance was published, should continue
treatment until they and their clinician consider it
www.nice.org.uk/guidance/ta430
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (November
2016) that sofosbuvir with velpatasvir (Epclusa ®) is
accepted for restricted use within NHS Scotland for the
treatment of adults with chronic hepatitis C infection of
The Scottish Medicines Consortium has advised (October
2017) that sofosbuvir with velpatasvir (Epclusa ®) is
accepted for restricted use within NHS Scotland for the
treatment of chronic hepatitis C virus (HCV) infection in
adults with genotype 2, 5 or 6 or decompensated cirrhosis,
irrespective of chronic HCV genotype. This advice is
contingent upon the continuing availability of the patient
access scheme in NHS Scotland or a list price that is
The Scottish Medicines Consortium has advised (April
2018) that sofosbuvir with velpatasvir (Epclusa ®) is
accepted for restricted use within NHS Scotland for the
treatment of chronic hepatitis C virus (HCV) infection in
adults with genotype 1 or 4. This advice is contingent upon
the continuing availability of the patient access scheme in
NHS Scotland or a list price that is equivalent or lower.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 25
▶ Epclusa (Gilead Sciences International Ltd) A
Velpatasvir 100 mg, Sofosbuvir 400 mg Epclusa 400mg/100mg
tablets | 28 tablet P £12,993.33
Sofosbuvir with velpatasvir and
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, sofosbuvir p. 628.
Chronic hepatitis C infection (specialist use only)
▶ Adult: 1 tablet once daily, for duration of treatment,
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Manufacturer advises reduce dose of concurrent H2-
receptor antagonist if above a dose comparable to
▶ Manufacturer advises reduce dose of concurrent proton
pump inhibitor if above a dose comparable to
l CAUTIONS Hepatitis B co-infection
l INTERACTIONS → Appendix 1: sofosbuvir. velpatasvir. voxilaprevir
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
moderate to severe impairment.
Vomiting Manufacturer advises if vomiting occurs within
4 hours of administration, an additional dose should be
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Sofosbuvir–velpatasvir–voxilaprevir for treating chronic
hepatitis C (February 2018) NICE TA507
Sofosbuvir with velpatasvir and voxilaprevir is
recommended as an option for treating adults with chronic
. of genotype 1 to 6 with or without compensated
cirrhosis (previously treated with direct-acting
antivirals)—recommended for 12 weeks, or
. of genotype 3 with or without compensated cirrhosis (no
treatment history with direct-acting antivirals)—
. the manufacturer provides the drug at the same price or
lower than that agreed with the Commercial Medicines
Patients whose treatment was started within the NHS
before this guidance was published should have the option
to continue treatment, without change to their funding
arrangements, until they and their NHS clinician consider
www.nice.org.uk/guidance/ta507
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2018)
that sofosbuvir with velpatasvir and voxilaprevir (Vosevi ®)
is accepted for restricted use within NHS Scotland for the
treatment of chronic hepatitis C virus (HCV) infection in
. have failed to achieve a sustained virologic response
(SVR) with a direct-acting anti-viral (DAA), or
. are DAA-naive, have genotype 3 (GT3) HCV infection,
with or without cirrhosis, and are suitable for treatment
This advice is contingent upon the continuing
availability of the patient access scheme in NHS Scotland
or a list price that is equivalent or lower.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21, 25
▶ Vosevi (Gilead Sciences International Ltd) A
Velpatasvir 100 mg, Voxilaprevir 100 mg, Sofosbuvir
400 mg Vosevi 400mg/100mg/100mg tablets | 28 tablet P £14,942.33
ANTIVIRALS › PROTEASE INHIBITORS, HEPATITIS
Glecaprevir with pibrentasvir 25-Oct-2017
Chronic hepatitis C (specialist use only)
▶ Adult: 300/120 mg once daily, for duration of
treatment, consult product literature
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y mg glecaprevir/pibrentasvir.
Cases of hepatitis B reactivation, sometimes fatal, have
been reported in patients co-infected with hepatitis B
and C viruses; manufacturer advises to assess patients
for hepatitis B prior to initiation of therapy and manage
according to current clinical guidelines.
MHRA/CHM ADVICE: DIRECT-ACTING ANTIVIRALS TO TREAT
CHRONIC HEPATITIS C: RISK OF INTERACTION WITH VITAMIN K
ANTAGONISTS AND CHANGES IN INR (JANUARY 2017)
An EU-wide review has identified that changes in liver
antagonists; the MHRA has advised that INR should be
monitored closely in patients receiving concomitant
MHRA/CHM ADVICE: DIRECT-ACTING ANTIVIRALS FOR CHRONIC
HEPATITIS C: RISK OF HYPOGLYCAEMIA IN PATIENTS WITH
glucose metabolism in patients with diabetes and result
in symptomatic hypoglycaemia if diabetic treatment is
The MHRA advises healthcare professionals:
. to monitor glucose levels closely in patients with
diabetes during direct-acting antiviral therapy for
hepatitis C, especially within the first 3 months of
treatment and modify diabetic medication or doses
. to be vigilant for changes in glucose tolerance and
advise patients of the risk of hypoglycaemia;
. to inform the healthcare professional in charge of the
diabetic care of the patient when direct-acting
antiviral therapy is initiated.
l CAUTIONS Hepatitis B infection . post-liver transplant
patients .re-treatment of patients with prior exposure to
NS3/4A- or NS5A-inhibitors—efficacy not established
l INTERACTIONS → Appendix 1: glecaprevir. pibrentasvir
▶ Common or very common Asthenia . diarrhoea . headache . nausea
▶ Frequency not known Pruritus .transient ischaemic attack
l PREGNANCY Manufacturer advises avoid—limited
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises avoid in
moderate to severe impairment (risk of increased
Missed doses Manufacturer advises if a dose is more than
18 hours late, the missed dose should not be taken and the
next dose should be taken at the normal time.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Glecaprevir–pibrentasvir for treating chronic hepatitis C
Glecaprevir with pibrentasvir is recommended, within its
marketing authorisation, as an option for treating chronic
hepatitis C in adults, only if the manufacturer provides the
drug at the same price or lower than that agreed with the
www.nice.org.uk/guidance/ta499
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (November
2017) that glecaprevir with pibrentasvir (Maviret ®) is
accepted for use within NHS Scotland for the treatment of
chronic hepatitis C virus (HCV) infection in adults. This
advice is contingent upon the continuing availability of
the patient access scheme in NHS Scotland or a list price
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21, 25
Pibrentasvir 40 mg, Glecaprevir 100 mg Maviret 100mg/40mg
tablets | 84 tablet P £12,993.66
l DRUG ACTION Dasabuvir is a non-nucleoside inhibitor of
hepatitis C virus polymerase NS5B, which is an essential
component of the hepatitis C virus replication process.
Chronic hepatitis C infection of genotype 1, in
combination with other antiviral drugs (ombitasvir with
paritaprevir and ritonavir, with or without ribavirin)
▶ Adult: 250 mg twice daily for details of duration of
treatment, consult product literature, dose to be taken
MHRA/CHM ADVICE: DIRECT-ACTING ANTIVIRALS TO TREAT
CHRONIC HEPATITIS C: RISK OF INTERACTION WITH VITAMIN K
ANTAGONISTS AND CHANGES IN INR (JANUARY 2017)
A EU-wide review has identified that changes in liver
antagonists; the MHRA has advised that INR should be
monitored closely in patients receiving concomitant
HEPATITIS B REACTIVATION (JANUARY 2017)
An EU-wide review has concluded that direct-acting
antiviral interferon-free regimens for chronic hepatitis C
can cause hepatitis B reactivation in patients co-infected
with hepatitis B and C viruses; the MHRA recommends
to screen patients for hepatitis B before starting
treatment—patients infected with both hepatitis B and C
viruses must be monitored and managed according to
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