A new drug for the treatment of HIV infection in adults has been launched in the UK.
Dolutegravir/rilpivirine is licenced for patients who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.
It is a two-drug regimen of dolutegravir (ViiV Healthcare) and rilpivirine (Janssen Therapeutics, Division of Janssen Products LP). A key driver for the 2-drug regimen is that people with HIV are now living into old age thanks to the advances of the past 30 years, so drug exposure is a key consideration (eg. lifetime exposure to treatment and interaction with drugs for age-related diseases such as arthritis, hypertension).
Marta Boffito, Consultant Physician in HIV medicine at The Chelsea and Westminster Hospital, said: “Due to treatment advances today, PLHIV are healthier and living longer than ever before. However, a life time of treatment exposes them to ongoing side-effects and drug-to-drug interactions which can negatively impact their quality of life.
"Clinical trials have shown that dolutegravir/rilpivirine is as effective as the current standard of care and is a potential treatment option to support PLHIV who are now growing old.”
Dolutegravir/rilpivirine is ViiV Healthcare’s first 2-drug regimen, once-daily, single-pill that combines dolutegravir the most widely prescribed integrase inhibitor (INI) worldwide, with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine. This launch brings a novel treatment option to the estimated 100,000 PLHIV in the UK who will now be on treatment for a lifetime.
The launch of dolutegravir/rilpivirine in the UK follows the European Commission (EC) granting marketing authorisation for dolutegravir/rilpivirine in May 2018. This was based primarily on data from the SWORD studies, presented at the Conference for Retroviruses and Opportunistic Infections 2017 and later published in The Lancet, which showed that a dolutegravir and rilpivirine regimen is non-inferior to traditional three and four drug regimens in maintaining virologic suppression (HIV-1 RNA <50 copies/mL) through 48 weeks in adults who are infected with HIV-1.
The individual SWORD-1 and SWORD-2 studies and the pooled SWORD data analysis demonstrated that dolutegravir plus rilpivirine is non-inferior to continued anti-retroviral treatment regimen, with 95% of subjects in both arms achieving the primary endpoint of <50 copies/mL plasma HIV-1 RNA at Week 48. Participating adults had stable plasma HIV-1 RNA (viral load <50 copies/mL) for 6 months or longer at screening, with no resistance to the individual components of Juluca.