UK Launch for Dolutegravir/Rilpivirine Combo Pill for HIV

Peter Russell

June 05, 2018

The UK launch has been announced  of the first combined two-drug, once-daily, single-pill for HIV, a combination of dolutegravir and rilpivirine.

Juluca (ViiV Healthcare UK Limited) was approved in May 2018 by the European Medicines Agency  (EMA) for adults whose levels of HIV-1 RNA in the blood have been below 50 copies/ml for at least 6 months on their current HIV treatment combination. 

It is not suitable for those whose HIV medicine has stopped working or who are infected with HIV that is resistant to medicines that work in the same way as Juluca's active substances.

Juluca's active substances are dolutegravir (50 mg), an integrase strand transfer inhibitor, and rilpivirine (25 mg) a non-nucleoside reverse transcriptase inhibitor.

Blocking Disease Progression

Dolutegravir has been authorised in the EU since 2014 and rilpivirine has been authorised since 2011. Both active substances block the actions of enzymes that HIV needs to make copies of itself in the cells it has infected.

The EMA said evidence from two main trials involving a total of 1028 patients found that Juluca was as effective for keeping HIV infection under control in eligible patients as combination treatment with three HIV medicines that include nucleoside reverse transcriptase inhibitors (NRTIs).

It said the most common side effects of Juluca – diarrhoea and headache – were easily managed.

The use of Juluca is not recommended for pregnant women.

HIV Treatment in Older Age

ViiV Healthcare, which is majority owned by GlaxoSmithKline, said the launch would bring a new treatment option to the estimated 100,000 people with HIV in the UK who will require treatment throughout their life.

A decision on the use of Juluca in England will depend on a review by NHS England's Clinical Commissioning Groups that oversee HIV treatment and care. The Scottish Medicines Consortium (SMC) is expected to issue its recommendation in September 2018.

Dr Michael Brady, medical director at the Terrence Higgins Trust, told Medscape News UK: "Being able to take fewer drugs is beneficial for everyone living with HIV. However, as people with HIV grow older they are more likely to require treatment for other medical conditions. 

"Being able to take fewer drugs for their HIV potentially makes it easier for people to manage their medication and reduces the risk of drug interactions."


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