Juluca, the first two-drug single-pill combination, has received marketing authorisation from the European Commission bringing it one step closer for patients.
Combination therapy, the very concept of multi drug HIV treatment, has been with us since the mid-nineties. Traditionally these combinations have been made up of three drugs, sometimes many more – depending on the individual circumstances.
We’re only just starting to understand the long-term consequences of taking these multiple powerful drugs over many years as we have our first cohort of people ageing with HIV. With this in mind the concept of taking fewer drugs, which are just as effective in managing HIV, becomes incredibly attractive.
Juluca is the first two-drug singe-pill to market. Juluca combines ViiV’s integrase-inhibitor (INI) Dolutegravir, and Janssen’s non-nucleoside reverse transcriptase inhibitor (NNRTI) Rilpivirine.
Juluca has shown high efficacy and safety at maintaining an undetectable viral load in patients with HIV-1 who have been undetectable for at least six months. Juluca is not suitable for patients who are treatment naïve (have not yet started treatment) or who have not achieved an undetectable viral load.
The pill is also the smallest single-pill HIV treatment to market, which may reap benefits for patients who have problems swallowing larger tablets, or larger numbers of tablets.
It is worth noting that due to the inclusion of Rilpivirine those taking Juluca should do so with a meal of 390kcal or more for optimal drug absorption.
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented:
“We are delighted to be able to provide dolutegravir with rilpivirine in a once-daily 2-drug regimen for PLHIV. ViiV Healthcare is committed to delivering innovative advances to meet the unmet needs of PLHIV and our robust clinical research programme has the potential to revolutionalise how we care for PLHIV for the long-term. With the advent of Juluca, we have found a way to reduce the number of antiretrovirals whilst maintaining the efficacy of the traditional 3-drug regimen. This is already being recognised by the European AIDS Society (EACS 2017) guidelines recommending a dolutegravir and rilpivirine regimen as a switch option for virologically suppressed patients.”
Deborah Waterhouse, CEO ViiV Healthcare, said:
“The European Commission Decision for Juluca is very positive news for people living with HIV (PLHIV) across Europe, who will now have the opportunity to maintain their viral suppression with a complete treatment regimen composed of only two drugs within a single-pill.”
The US FDA approved Juluca back in November 2017.