MSD’s new HIV-1 treatment approved for use on the NHS

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MSD’s new HIV-1 treatment has been approved for use on the NHS. MSD has announced that its new treatment for HIV-1 infection – doravirine▼ – has been recommended for NHS use in England. The decision means that people living with HIV in England will be first to have routine access to doravirine in the UK.

Doravirine sits in a class of treatments known as NNRTIs (non-nucleoside reverse transcriptase inhibitors) that work by blocking the action of reverse transcriptase, an enzyme that plays a key role in helping HIV replicate in the body. Doravirine is a re-engineered molecule that has been specifically designed to address some particular challenges of the NNRTI class related to treatment including resistance, side effects and tolerability.

The once-daily fixed dose combination will be known as DELSTRIGO®▼ (100 mg doravirine, 300 mg lamivudine, 300 mg tenofovir disoproxil fumarate) and the single-entity tablet PIFELTRO®▼ (100 mg doravirine). This means doravirine can therefore be used in combination with other tablets to make a triple-combination treatment or as a complete triple combination in a single daily pill.

Welcoming the news Professor Chloe Orkin, Clinical Professor of HIV Medicine at Queen Mary University of London’s Blizard Institute said: “Advances in HIV medication have led to dramatic improvements in life expectancy. Many people with HIV are living near normal life expectancies extending into old age. We need to continue to develop new treatments that enable us to effectively treat the virus, whilst having minimal side effects, thus enabling a better quality of life. This is why I welcome today’s news granting reimbursement for doravirine. It offers clinicians and people living with HIV in England another effective treatment option that has few side effects.”

In 2018, the UK was one of the first countries to achieve the UNAIDS 90:90:90 goal, two years ahead of the 2020 target. Alongside comprehensive testing programmes, clinical innovation has continued to play a key role in helping achieve this ambition with the introduction of pre-exposure prophylaxis (PrEP), as well as new types and combinations of treatments which render the virus undetectable in the human body, and therefore untransmittable to others. However, while advances in medicines have transformed prospects for people living with HIV, many advocates note that challenges remain.

“People living with HIV continue to be disproportionately affected by health and social issues: they are twice as likely to have depression and anxiety, suffer increased financial stress, and face HIV-related stigma. As a community our challenge is to raise attention of these broader needs, and our mission: to make sure that people with HIV are able to live as well as they can. Medication plays a huge part in this and whilst today we have some excellent treatments, there is more to ‘living well’ than suppression of the virus alone. That is why continued clinical innovation, with new therapies like doravirine that help lead us ever closer towards this goal, is warmly welcomed by the clinical community” commented Dr Andrew Ustianowski, Consultant in Infectious Diseases & Tropical Medicine, North Manchester General Hospital.

MSD has been involved in HIV research for more than 30 years and was one of the first companies to discover and develop medicines for the treatment of HIV, including being the first organisation to publish the crystal structure of HIV-1 protease.

Speaking on behalf of MSD, Debbie Porter, Executive Director of the Specialty Care Business Unit commented: “MSD is committed to meeting the needs of people living with HIV, from our clinical innovations, like doravirine, to our community projects such as ‘Whole Person Care’ which recognises the need to put people living with HIV at the centre of their care. Our ongoing global research is seeking to invent new ways to prevent HIV infection and even explore potential ways to cure the infection in future – there is still so much to do. While our search for a cure continues, MSD is committed to providing treatment options that are sustainable for the NHS, in full support of the wider aim of eliminating new transmissions.”

Doravirine was assessed for reimbursement by the NHS England Clinical Reference Group for HIV through the Clinical Commissioning Policy process which is used to assess HIV medicines in England. MSD continues to be fully engaged with funding bodies and decision makers across the devolved nations to ensure doravirine becomes available widely across the UK as soon as possible.