Velpatasvir: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 24, 2026🚩 Report this page

Velpatasvir

Active ingredient

GB MHRA

Drug class: -
Availability: See label
Markets covered: 1
Products on record: 4

Overview

Velpatasvir is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	April 24, 2026

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised April 24, 2026[1]

1).

How to take

GBOfficial regulatory label· revised April 24, 2026

Drug interactions

Known interactions involving Velpatasvir. Select one for details. This list is informational and not a complete interaction checker.

Berotralstat Bosentan Cenobamate Colchicine Dabrafenib Dexamethasone Dexlansoprazole Edoxaban Efavirenz Enzalutamide Esomeprazole Etravirine Lansoprazole Mitotane Nafcillin Nevirapine Omeprazole Pantoprazole Pexidartinib Rabeprazole Relugolix Rosuvastatin Abametapir Abiraterone Afatinib Aliskiren Aluminum Hydroxide Apixaban Atorvastatin Betrixaban Binimetinib Bosutinib Brentuximab Vedotin Calcium Carbonate Cimetidine Cobimetinib Daunorubicin Dicumarol Digoxin Everolimus Famotidine Gilteritinib Idarubicin Idelalisib Lefamulin Lemborexant Letermovir Lovastatin Lusutrombopag Magaldrate Magnesium Carbonate Magnesium Hydroxide Magnesium Oxide Maraviroc Mitoxantrone Naldemedine Nizatidine Olaparib Ranitidine Revefenacin Ribociclib Ripretinib Rucaparib Selpercatinib Simvastatin Sodium Bicarbonate Sodium Citrate Somapacitan Somatrem Somatropin Talazoparib Telotristat Ethyl Topotecan Ubrogepant Vemurafenib Voxilaprevir Fidaxomicin Indacaterol Naloxegol Prucalopride

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB119720030 · revised April 24, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Sofosbuvir/Velpatasvir/Voxilaprevir Gilead treatment should be initiated and monitored by a physician experienced in themanagement of patients with HCV infection. 2). The recommended durations of treatment applicable to all HCV genotypes are shownin Table 1.
1) DAA experienced patients* without cirrhosis or with compensated cirrhosis 12 weeks DAA: direct-acting antiviral agent * In clinical studies the DAA experienced patients had been exposed to combination regimens containing any of the following: daclatasvir, dasabuvir, elbasvir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, sofosbuvir, velpatasvir,voxilaprevir (administered with sofosbuvir and velpatasvir for less than 12 weeks).
Missed dose If a dose of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet(s) as soon as possible and then patients shouldtake the next dose at the usual time.
If it is after 18 hours then patients should be instructed to wait and take the next dose of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead at the usual time. Patients shouldbe instructed not to take a double dose of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead.
Patients should be instructed that if vomiting occurs within 4 hours of dosing an additional dose of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead should be taken. 1). 2). Renal impairment No dose adjustment of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead is required for patients with mild or moderate renalimpairment.
73 m2) and end stage renal disease (ESRD) requiring haemodialysis. Sofosbuvir/Velpatasvir/Voxilaprevir Gilead has not been studied in patients with ESRD requiring dialysis. 2). Hepatic impairment No dose adjustment of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead is required for patients with mild hepatic impairment (Child-Pugh- Turcotte [CPT] Class A).
2). Paediatric population The safety and efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead in children aged less than 12 years and weighing less than 30 kg have not yet been established. No data are available. Method of administration For oral use.
2). Due to the bitter taste, it is recommended that the film- coated tablet isnot chewed or crushed.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 24, 2026[1]

1% for patients receiving sofosbuvir/velpatasvir/voxilaprevir for 8 weeks. There were no patients receiving sofosbuvir/velpatasvir/voxilaprevir for 12 weeks who permanently discontinued treatment due to adverse reactions in the Phase 2 and 3 pivotal clinical studies.
Tabulated summary of adverse reactions Assessment of adverse reactions for Sofosbuvir/Velpatasvir/Voxilaprevir Gilead is based on safety data from clinical studies and post-marketing experience. The adverse reactions are listed below by system organ class and frequency.
Frequencies are defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000) or very rare (< 1/10,000).
Table 3:
Adverse reactions identified with Sofosbuvir/Velpatasvir/Voxilaprevir Gilead Frequency Adverse reaction Nervous system disorders: Very common headache Gastrointestinal disorders: Very common diarrhoea, nausea Common abdominal pain, decreased appetite, vomiting Skin and subcutaneous tissue disorders: Common rash Uncommon angioedemaa Musculoskeletal and connective tissue disorders: Common myalgia Uncommon muscle spasm Laboratory investigations: Common total bilirubin increased a.
5). 5 x the upper limit of normal were observed in 4% of patients without cirrhosis and 10% of patientswith compensated cirrhosis, due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir. Total bilirubin levels decreased after completing Sofosbuvir/Velpatasvir/Voxilaprevir Gilead treatment.
Patients with renal impairment The safety of sofosbuvir in a fixed dose combination with either ledipasvir or velpatasvir has been studied in 154 patients with ESRD requiring dialysis (Study 4062and Study 4063). In this setting, exposure of sofosbuvir metabolite GS-331007 is 20- fold increased, exceeding levels where adverse reactions have been observed in preclinical studies.
In this limited clinical safety data set, the rate of adverse events and deaths was not clearly elevated from what is expected in ESRD patients. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinalproduct. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Paediatric population The safety assessment of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead in paediatric patients aged 12 years and older is based on data from 21 DAA- naïve patients with genotype 1, 2, 3, or 4 HCV infection (without cirrhosis) who were treated with Sofosbuvir/Velpatasvir/Voxilaprevir Gilead for 8 weeks in a Phase 2, open-label clinical study (study 1175).
The adverse reactions observed were consistent with those observed in clinical studies of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead in adults.

GBOfficial regulatory label· Warnings and precautions· revised April 24, 2026[1]

Severe bradycardia and heart block Life-threatening cases of severe bradycardia and heart block have been observed when sofosbuvir containing regimens are used in combination with amiodarone. Bradycardia has generally occurred within hours to days, but cases with a longer timeto onset have been observed mostly up to 2 weeks after initiating HCV treatment.
Amiodarone should only be used in patients on Sofosbuvir/Velpatasvir/Voxilaprevir Gilead when other alternative anti-arrhythmic treatments are not tolerated or are contraindicated. Should concomitant use of amiodarone be considered necessary, it is recommended that patients undergo cardiac monitoring in an in-patient setting for the first 48 hoursof coadministration, after which outpatient or self-monitoring of the heart rate shouldoccur on a daily basis through at least the first 2 weeks of treatment.
Due to the long half-life of amiodarone, cardiac monitoring as outlined above should also be carried out for patients who have discontinued amiodarone within the past fewmonths and are to be initiated on Sofosbuvir/Velpatasvir/Voxilaprevir Gilead.
All patients with concurrent or recent use of amiodarone should be warned of thesymptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them. HCV/HBV co-infection There are no data on the use of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead in patients with HCV/hepatitis B virus (HBV)co-infection.
Cases of HBV reactivation, some of them fatal, have been reported during or after treatment with DAAs. HBV screening should be performed in all patients before initiation of treatment. HCV/HBV co- infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current clinical guidelines.
73 m2) and ESRD requiring haemodialysis. 2). Hepatic impairment No dose adjustment of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead is required for patients with mild hepatic impairment(CPT Class A). 2). Liver transplant patients The safety and efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead in the treatment of HCV infection in patients who are post-liver transplant have not been assessed.
2), should be guided by an assessment of the potential benefits and risks for the individual patient. g. efavirenz, modafinil, oxcarbazepine or rifapentine) may decrease sofosbuvir, velpatasvir and/or voxilaprevir plasma concentrations leading to reduced therapeuticeffect of Sofosbuvir/Velpatasvir/Voxilaprevir Gilead.

This is not medical advice. Consult a qualified healthcare professional.