NICE has published draft guidance recommending the first long-acting injectable treatment for HIV-1 infection in adults, offering an alternative to adults living with HIV who have to take daily antiretroviral drugs. This marks the first time NICE has made recommendations about the use of an HIV treatment since these came under NICE’s remit in 2019.

Cabotegravir (also known as Vocabria), made by ViiV Healthcare, with rilpivirine (also called Rekambys), made by Janssen, has been shown in clinical trials to be as effective as oral antiretrovirals at keeping the viral load low. Both are administered as two separate injections, every two months, after an initial oral tablet lead-in period. This reduces treatment from 365 to six per year.

The treatment is recommended as an option for adults with HIV-1 infection when antiretroviral medicines have kept the virus at a low level, and where there is no evidence to suspect viral resistance. It is estimated that around 13,000 people in England will now be eligible for treatment with cabotegravir with rilpivirine.

The announcement follows a positive decision from the SMC in October 2021, enabling those living with HIV in Scotland access to the long-acting injectable regimen within NHS Scotland.

GlaxoSmithKline (GSK) announced that the European Commission has approved Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5 (IL-5) for use in three additional eosinophil-driven diseases.

This marks the first targeted treatment for eosinophilic granulomatosis with polyangiitis (EGPA), and the first anti-IL-5 biologic treatment for patients with hypereosinophilic syndrome (HES), or chronic rhinosinusitis with nasal polyps in Europe.

Both HES and EGPA are potentially life-threatening rare diseases emerging from inflammation in various tissues, which can cause a range of frequently severe symptoms.

Mepolizumab is now the only treatment approved in Europe for use in four eosinophil-driven diseases and is already approved for use in Europe as an add-on treatment for patients aged six years and older with severe eosinophilic asthma (SEA).
Dr Hal Barron, chief scientific officer and president R&D, GSK, said: “With millions of patients across Europe affected by eosinophil-driven diseases, we recognise the urgency in delivering the first approved targeted treatment for use in four of these conditions. Today’s approvals reinforce the important role treatments such as mepolizumab can play in helping to improve the lives of patients with these debilitating diseases.”

Vertex has announced that the EMA adopted a positive opinion for the label extension of Kaftrio, in a combination regiment with ivacaftor, for the treatment of cystic fibrosis (CF) in patients aged six to 11 years of age.

Those eligible will have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. If approved, over 1,500 children will be eligible for a medicine which can treat the underlying cause of their disease for the first time.

In those with certain types of mutations in the CFTR gene, the CFTR protein is not processed or folded normally within the cell, which can prevent the CFTR protein from reaching the cell surface and functioning properly. Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor is an oral medicine designed to increase the quantity and function of the CFTR protein at the cell surface.

“Today marks an important milestone for the treatment of children with CF in Europe. If approved, Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor will offer physicians a new treatment option for these young patients to help combat this life-shortening condition as early as possible,” said Carmen Bozic, executive vice president, Global Medicines Development and Medical Affairs, and chief medical officer at Vertex.

The chief executive of the NHS, Amanda Pritchard, has announced a deal on a life-saving treatment, expanding the health service’s use of drugs designed to stop blood clots.

This deal will see more patients having access to treatment which could prevent 21,700 strokes and 5,400 deaths.

The usual treatment to prevent blood clots requires patients to attend their GP or hospital regularly, but with the introduction of these new drugs, patients will only be required to go to hospital once a year.

The drugs prevent strokes by treating and preventing blood clots in patients with atrial fibrillation (AF), a condition that causes an irregular and often abnormally fast heart rate. The NHS will now dramatically scale up the use of direct oral anticoagulants (DOACs), with as many as 610,000 more patients benefiting from the deal over the next three years, starting from January 2022. This agreement and the use of these drugs expands the NHS Long Term Plan commitment to tackle strokes and other cardiovascular disease.

Helen Williams, NHS England national speciality adviser for Cardiovascular Disease Prevention, said: “Not only is stroke one of the biggest killers in our country, but it leads to life-changing and often devastating long-term harm for many others, so by ensuring these drugs are made available for all people with atrial fibrillation who are at risk of stroke, the NHS will not only prevent serious harm to the people affected, but avoid the need for aftercare which puts additional pressure on the health service.”