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Vosevi▼ (sofosbuvir + velpatasvir + voxilaprevir) - new side effect information

Vosevi▼, from Gilead

About medicine

Gilead, the manufacturers of the chronic hepatitis C virus treatment containing sofosbuvir and velpatasvir and voxilaprevir, brand name Vosevi▼, have added two new side effects. These adverse reactions were identified through post-marketing surveillance for sofosbuvir/velpatasvir-containing products.

These side effects are:
  • Angioedema
  • Rash
Angioedema is swelling underneath the skin. It's usually a reaction to a trigger, such as a medicine or something you're allergic to.

It is not normally serious, but it can be a recurring problem for some people and can very occasionally be life-threatening if it affects breathing.

The swelling most often affects the:
  • hands
  • feet
  • area around the eyes
  • lips and tongue
  • genitals
Many people also have a raised, itchy rash called urticaria (hives).

In more serious cases, angioedema can also cause breathing difficulties, tummy (abdominal) pain and dizziness.

You can follow developments on Vosevi by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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NICE approve Vosevi for use in treatment of hepatitis C

Vosevi▼, from Gilead

About medicine

The National Institute for Health and Care Excellence (NICE) have approved Gilead's Vosevi (which contains three active medicines, sofosbuvir, velpatasvir and voxilaprevir) as an option for treating chronic hepatitis C in adults.

This means that Vosevi will be available for use by NHS England and NHS Wales.

The Scottish Medicines Consortium is due to make a decision in April 2018.

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Hepatitis C treatment Vosevi gets approval in EU

Vosevi▼, from Gilead

About medicine

On July 26th 2017 the EMA issued a marketing authorisation for Gilead's hepatitis C treatment, a combination of ofosbuvir, velpatasvir and voxilaprevir (Vosevi), for use in the EU.

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Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.