First long-acting injectable HIV treatment appraised and approved by NICE

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, is pleased to announce that eligible people living with Human Immunodeficiency Virus (HIV) in England and Wales will soon have routine access to Vocabria (cabotegravir long-acting injection) developed by ViiV Healthcare in combination with Rekambys (rilpivirine long-acting injection), developed by Janssen Sciences Ireland UC (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson.

This comes as the National Institute for Health and Care Excellence (NICE) published a positive Final Appraisal Document (FAD), recommending the combination for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitor (NNRTI) and integrase inhibitor (INI) class.

This is the first time a HIV treatment has ever been appraised and approved by NICE and means that eligible people living with HIV in England and Wales will soon be able to receive the complete long-acting injectable regimen once every two months, following an initiation phase (oral lead in and initiation injections), as opposed to regular, daily oral treatment. The announcement follows a positive decision from the Scottish Medicines Consortium (SMC) in October 2021, enabling people living with HIV in Scotland to access the long-acting injectable regimen within NHS Scotland.

We still have a long way to go in educating around HIV, but today’s announcement demonstrates how far we’ve come since the 1980s epidemic. It is a huge step forward in offering people living with HIV in England and Wales greater choice in how they manage their condition. Having to take tablet​s every day can be physically, emotionally and socially burdensome for some people. This decision reflects the rightful need for people living with HIV to have the freedom to manage their HIV in a way that works best for them, helping them to live their life to the full.”

Garry Brough, Positively UK

In a recent survey carried out among people living with HIV*, 60% live in fear that their HIV status will be shared without their consent, with 45% saying they have been forced to share their HIV status because someone spotted the medicine they were taking. In addition, more than half (55%) of people with HIV surveyed agree that fear of their HIV status being shared unintentionally stops them living their day-to-day life as they would like to, with 56% saying they avoid certain social situations as a result.

In the same survey*, 85% of people living with HIV agree that having the choice over how often they take their medication would have a positive impact on their life.

At ViiV Healthcare, our mission is to ensure that no one living with HIV is left behind and we recognise that there are still unmet needs in both the choice of medication they take, and how often they take it. We understand that no medicine works for every individual living with HIV, so we are committed to offering innovative choices that help address their evolving needs. We are delighted that NICE has approved the first and only complete long-acting injectable HIV medicine, allowing us to focus on the people living with the condition and provide them with treatment options that remove the need for regular daily HIV tablets.”

Dr Nneka Nwokolo, ViiV Healthcare UK

The combination of cabotegravir and rilpivirine is the first and only once-every-two-month, complete long-acting injectable regimen for virologically suppressed adults living with HIV-1. Phase 3 clinical studies showed non-inferior efficacy of long-acting injectable cabotegravir and rilpivirine, dosed monthly, to daily oral antiretroviral therapy. Furthermore, in the ATLAS-2M study, which included 1,045 participants, the once-every-two-month regimen showed non-inferior efficacy to monthly cabotegravir and rilpivirine injections. The safety profile was similar between dosing groups, the most common adverse reactions included injection site reactions, headache, and pyrexia (fever).

Importantly, a secondary endpoint in the ATLAS-2M clinical trial looking at patient preference showed that treatment once every two months was preferred by 98% of participants over daily oral therapy. Cabotegravir and rilpivirine are administered as two intramuscular injections in the buttocks, during the same visit at a specialist clinic by a healthcare professional. Prior to the initiation of the injections, cabotegravir and rilpivirine oral tablets are taken for approximately one month (at least 28 days) to assess tolerability to the medicines.

The FAD represents finalisation of the NICE Committee recommendations and forms the basis of the final Technology Appraisal Guidance (TAG) issued to the NHS in England and Wales, which is expected to be published on 5^th January 2022. Pending any appeals from consultees, based on the positive FAD, the NHS should make the combination of cabotegravir and rilpivirine available in England and Wales within three months of publication of the TAG.

ViiV Healthcare’s cabotegravir in combination with Janssen’s rilpivirine was co-developed as part of a collaboration with Janssen and builds on ViiV Healthcare’s industry-leading portfolio that is centred around delivering innovative medicines for the HIV community.