1 What is this medicine
and what is it used for?
Sofosvel is a once-daily, all-oral, pan-genotypic (effective
against all HCV genotypes 1–6) treatment for chronic hepatitis C virus (HCV)
infection in adults and children aged 6 years and older (weighing at least 17
kg). It combines two different antiviral mechanisms:
• Sofosbuvir: an NS5B RNA polymerase
inhibitor — blocks the enzyme HCV uses to copy its genetic material.
• Velpatasvir: an NS5A protein
inhibitor — blocks a protein essential for HCV replication and assembly.
This dual mechanism, targeting two different points in the
viral lifecycle, makes it highly effective with very low rates of resistance
development. A 12-week course achieves sustained virological response (SVR —
'cure') rates exceeding 95% in most patient groups.
It is used for: all HCV genotypes (1–6); compensated and
decompensated liver cirrhosis (with or without ribavirin); and treatment-naive
or treatment-experienced patients.
2 How to take this
medicine
One tablet (sofosbuvir 400 mg + velpatasvir 100 mg) taken
once daily with or without food. Treatment duration is 12 weeks for most
patients. Patients with decompensated cirrhosis receive sofosbuvir/velpatasvir
plus ribavirin for 12 weeks. Swallow the tablet whole — do not crush or chew.
|
Take at the same time
every day — consistency maintains effective antiviral drug levels. Do not stop treatment
early even if you feel well — incomplete courses risk treatment failure and
resistance. Avoid taking antacids
within 4 hours of sofosbuvir/velpatasvir — they can reduce absorption. |
3 Possible side effects
|
Frequency |
Side Effect |
What to Do |
|
Very Common (>10%) |
Headache |
Paracetamol if needed.
Usually mild; resolves with continued treatment. |
|
Very Common (>10%) |
Fatigue |
Rest as needed;
usually mild. Distinguish from underlying liver disease symptoms. |
|
Common (1–10%) |
Nausea |
Take with a light meal
if needed. |
|
Common (1–10%) |
Insomnia |
Maintain regular sleep
schedule; discuss with doctor if persistent. |
|
Common (1–10%) |
Pruritus (itching) |
Keep skin moisturised;
inform your doctor. |
|
Common (1–10%) |
Rash |
Report any rash — may
be drug-related or related to hepatitis C. |
|
Uncommon |
Bradycardia (with
amiodarone co-use — serious) |
NEVER combine with
amiodarone without specialist input — see warning box. |
|
Uncommon |
Anaemia (when combined
with ribavirin) |
Regular blood count
monitoring during combination therapy. |
|
Seek help urgently |
Signs of HBV
reactivation: jaundice, dark urine, severe fatigue, abdominal pain |
Seek urgent medical
review — HBV reactivation can be fatal. |
|
CRITICAL WARNINGS: HEPATITIS B REACTIVATION: All patients must be
tested for hepatitis B (HBsAg, anti-HBc) before starting
sofosbuvir/velpatasvir. HBV reactivation during or after HCV treatment with
DAAs can be severe, including fulminant hepatitis and death. HBV co-infected
patients require HBV antiviral prophylaxis or close monitoring. AMIODARONE: Do NOT co-administer with
amiodarone — serious symptomatic bradycardia (including fatal cardiac arrest)
has been reported. If amiodarone cannot be stopped, intensive cardiac
monitoring is required. DRUG INTERACTIONS: Multiple significant
interactions via P-gp, BCRP, and OATP transporters — always screen carefully. |
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4 Who should not take
this medicine
Sofosvel should not be used: with rifampicin, rifabutin,
carbamazepine, phenytoin, phenobarbital, or St John's Wort (potent P-gp/CYP
inducers — reduce levels to sub-therapeutic); with amiodarone (bradycardia
risk); in known hypersensitivity to sofosbuvir, velpatasvir or excipients.
Use with caution in severe renal impairment (eGFR <30
mL/min/1.73 m2) — accumulation of inactive sofosbuvir metabolite; specialist
guidance required.
5 Medicines that interact
with this treatment
• Potent P-gp/CYP inducers (rifampicin,
St John's Wort, carbamazepine, phenytoin): CONTRAINDICATED — dramatically
reduce drug levels.
• Antacids (aluminium/magnesium
hydroxide): separate by at least 4 hours.
• Proton pump inhibitors (omeprazole,
lansoprazole): take sofosbuvir/velpatasvir with food, and PPI at the same time
or within 4 hours; limit to omeprazole 20 mg equivalent dose.
• H2-receptor antagonists (ranitidine,
famotidine): take simultaneously or 12 hours apart.
• Amiodarone: CONTRAINDICATED.
• Statins (rosuvastatin, atorvastatin):
dose adjustment or monitoring required due to increased statin exposure.
• Digoxin: increased levels — monitor.
• Tenofovir-containing HIV regimens:
increased tenofovir exposure — monitor renal function and bone density.
6 How to store this
medicine
Store below 30°C. Keep in original packaging. Keep out of
reach of children. Do not use after the expiry date.
7 Prescription
requirement
|
PRESCRIPTION ONLY
MEDICINE (POM) — Prescribed by a hepatologist, gastroenterologist or
specialist in infectious diseases. Pre-treatment: HCV
genotype (optional for pan-genotypic), HBsAg, anti-HBc, LFTs, renal function,
FIB-4/Fibroscan for fibrosis staging. |
8 Guidance for patients
& caregivers
A 12-week course of sofosbuvir/velpatasvir cures hepatitis C
in more than 95% of patients — this is a remarkable achievement for a
once-deadly infection. To maximise your chances of cure, take every tablet, at
the same time each day, for the full 12 weeks. Missing doses significantly
reduces your chances of cure.
Being cured of hepatitis C means the virus becomes
undetectable in your blood 12 weeks after completing treatment (SVR12). Your
liver can still carry some scarring (fibrosis or cirrhosis) from the years of
infection — your doctor will monitor you for this, and for liver cancer
screening in patients with cirrhosis.
Test and treat all close contacts and household members who
may have been exposed — hepatitis C is transmitted primarily through
blood-to-blood contact.
9 Pharmacist &
prescriber notes
Sofosvel (sofosbuvir/velpatasvir) is the generic/branded
generic equivalent of Epclusa (Gilead). It is pan-genotypic — no HCV genotyping
is required before prescribing. SVR12 rates: GT1–6 without cirrhosis — 99%;
with compensated cirrhosis — 99%; with decompensated cirrhosis (+ ribavirin) —
83–94%. Screen all patients for HBV co-infection before starting (FDA black box
warning since 2016).
Drug interactions are principally mediated by
OATP1B/P-gp/BCRP — the most clinically significant are potent inducers
(absolute contraindication) and amiodarone (absolute contraindication). For
patients on acid-reducing agents: H2 antagonists and low-dose PPIs can be
managed with timing adjustments; high-dose PPI should be avoided if possible.
Renal impairment: no dose adjustment needed if eGFR >30; for eGFR <30 —
specialist guidance required.
10 Frequently asked
questions
Is this a cure for hepatitis C?
Yes — in the vast majority of
patients. Achieving SVR12 (undetectable HCV in blood 12 weeks after completing
treatment) is considered a virological cure. Your immune system cannot clear
any remaining scar tissue from your liver, but the virus itself will be
eliminated.
Can I drink alcohol while taking this treatment?
Alcohol causes liver inflammation and
accelerates liver damage, which counteracts the benefit of clearing HCV.
Ideally avoid alcohol completely during and after treatment, especially if you
have any degree of cirrhosis.
Do I need to tell my partner about my hepatitis C?
Yes — hepatitis C can be transmitted
through shared needles, blood contact, and potentially (less efficiently)
through sexual contact. Partners should be tested and treated if positive.
What if I miss a dose?
If you remember within 18 hours of
your scheduled dose, take it immediately. If more than 18 hours have passed,
skip the missed dose and continue the next day. Do not double up.
I have cirrhosis — is this treatment safe for me?
Yes — sofosbuvir/velpatasvir is used
in patients with compensated and decompensated cirrhosis. In decompensated
cirrhosis, ribavirin is added to the regimen. Patients with cirrhosis require
closer monitoring and ongoing liver cancer surveillance after treatment.