EMA approves dolutegravir/rilpivirine (Juluca) in Europe as dual-therapy HIV switch option
8 June 2018. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 21 May 2018, the oral fixed dose combination (FDC) of dolutegravir/rilpivirine was approved by the EU as a switch option for people stable on ART for more than six months. The indication also includes no history of treatment failure or drug resistance.
The fixed dose combination is notable for only containing two active drugs, and for being an NRTI-free combination.
- Standard adult dose is once pill, once daily.
- Juluca needs to be taken with food (to boost the rilpivirine).
- A drug interaction with the TB medicine rifabutin requires taking an additional daily 25 mg rilpivirine tablet.
- Other drug interactions mean that Juluca should not be taken with the following drugs: dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors (including: esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole), St. John’s wort, or more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate,
- No dose adjustment is needed with mild or moderate kidney damage (defined as CrCl greater than 30mL/min). Increased monitoring is recommended in more severe kidney damage (CrCl less than 30mL/min).
- No dose adjustment is needed with mild or moderate liver damage.
This FDC is a collaboration between ViiV Healthcare (dolutegravir) and Janssen Pharmaceutical (rilpivirine) and is marketed under the brand name Juluca.
Juluca was approved in the US in November 2017.
For further details please see the full prescribing information.
comment
Although Juluca has been launched in the UK, access will depend on different NHS procedures by the NHS in each country.
- Scotland. Juluca has been submitted to the SMC with an anticipated reimbursement decision by September/October 2018.
- Northern Ireland has similar timing to NHS Scotland – expected September/October 2018.
- England. Timing is more difficult to predict based on the timeline of the specialised commissioning process. Expect early 2019.
- Wales. Timing still to be confirmed.
Reference
- ViiV press statement, ViiV Healthcare receives EU marketing authorisation for Juluca (dolutegravir/rilpivirine), the first 2-drug regimen, once-daily, single-pill for the treatment of HIV. (21 May 2018).
https://www.viivhealthcare.com/media (media page)
https://www.viivhealthcare.com/media/press-releases/2018/may/viiv-healthcare-receives-eu-marketing-authorisation-for-juluca-dolutegravirrilpivirine-the-first-2-drug-regimen-once-daily-single-pill-for-the-treatment-of-hiv.aspx (direct link)