November 18, 2021

expert reaction to new NICE guidance on a long-acting injectable HIV-1 treatment

The National Institute for Health and Care Excellence (NICE) has published a draft guidance recommending cabotegravir with rilpivirine, the first long-acting injectable treatment for HIV-1 infection in adults.

Dr Sanjay Bhagani, Consultant Physician/Associate Professor in Infectious Diseases/HIV Medicine, and President, European AIDS Clinical Society (EACS), said:

“This is the first time NICE has made a recommendation on anti-retroviral therapy (ART).

“This is very welcome indeed, and a clear indication of what is already well-established – ART prolongs life in people living with HIV, is cost-effective and prevents transmission to their partners, the concept of ‘undetectable equals untransmissable U=U’.

“This is the first ART regimen that has been approved that is both injectable and long-acting (injections every two months) and will provide a viable alternative for people living with HIV who are unable to take daily tablets.  Stigma remains a significant issue in the HIV community, and taking tablets everyday may be difficult for some people.  This offers an injectable alternative for many people.  It is important to note that this treatment is only suitable for those that have already achieved undetectable levels of virus in blood whilst taking tablets.  The data and studies underpinning this recommendation are solid, and real-world experience suggest that patients that start injectable treatments prefer to stay on them.

“This regimen is now recommended in all the major HIV treatment guidelines in Europe and across the world.  NICE approval, and roll-out in the NHS will bring us in line with these guidelines.”

Prof Chloe Orkin, Professor of HIV Medicine at Queen Mary University of London, said:

“This is a paradigm-shifting moment in the UK where, for the first time, it is possible to release people with HIV from the burden of daily oral therapy and offer them instead just 6 treatments per year.

“This long-acting  injectable combination has been shown to be as safe and as effective as existing oral combinations in several large international trials and consequently is now recommended in European and US guidelines.”

Dr Jonathan Stoye, Senior Group Leader and Head of the Retrovirus-Host Interactions Laboratory, The Francis Crick Institute, said:

“Drug treatment of HIV-1 has been one of the great successes of modern medicine.  While HIV-1 was once a virtual death sentence from AIDS, combination therapy now allows an essentially normal life span.  However almost all treatments require taking medicines at least once a day.  This is inconvenient and brings with it the risk of missing doses essential for virus control.  The approval by NICE, following the example of the FDA and EMA, of a long-acting injectable treatment must therefore be warmly welcomed.  One might hope that this decision foreshadows the use of long-acting drugs for pre-exposure prophylaxis in at risk populations.”

‘NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE: Final appraisal document; Cabotegravir with rilpivirine for treating HIV-1’ was published at 00:01 UK time on Thursday 18 November 2021.

Declared interests

Prof Chloe Orkin: “I am the first author and lead investigator for one of the three major trials of this injectable combination (The FLAIR study).

As the lead for clinical trials I have received research grants to my institution from all the major HIV pharma companies including Viiv Healthcare and GSK, Gilead, MSD, Astra Zeneca  and Janssen.  I have also received honoraria for scientific advisory boards, lecture fees from the same companies.”

Dr Jonathan Stoye: “No interests to declare.”

None others received.