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SOFOSVEL (SOFOSBUVIR 400MG + VELPATASVIR 100MG) TABLETS 28`S

Ksh 45,499

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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.

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.

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.

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.

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.

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.

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.

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.

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.


 

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