The first dual therapy single-pill, Juluca, has been approved for use by the FDA – giving people living with HIV the chance to take fewer drugs.
Juluca, as the pill will be branded, is comprised of 50mg Dolutegravir and 50mg (an integrase strand transfer inhibitor or INI) and Rilpivirine 25mg (a non-nucleoside reverse transcriptase inhibitor or NNRTI).
This new treatment option isn’t targeted at newly diagnosed people, but rather at people who’ve already achieved a stable undetectable load on traditional combination therapy. This has been coined as ‘maintenance therapy’.
The option to take two drugs instead of three, four or even five is a now a real option for those concerned about the impact multiple HIV drugs have on their long term health.
This FDA approval is based primarily upon data from two pivotal phase III clinical trials, SWORD-1 and SWORD-2, showed the two-drug regimen achieved non-inferior viral suppression (less than 50 copies per mL) at 48 weeks compared with a three-or four-drug regimens.
Deborah Waterhouse, CEO ViiV Healthcare said:
“The FDA approval of Juluca marks an important milestone in our commitment to deliver innovative advances in HIV care by providing new treatment options that challenge the traditional approach to care. This is the start of a new era in HIV treatment. We are delighted to be able to provide the first 2-drug regimen to physicians and people living with HIV in the US, to support the reduction of long-term ART exposure as they receive life-long treatment for their chronic condition.”
John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented:
“Juluca is the first medicine in our 2-drug regimen pipeline, which looks to help lessen the lifetime burden of treatment for people living with HIV. Our R&D efforts are exploring the potential of two further 2-drug regimens both in phase III development, a once-daily, single pill containing dolutegravir/lamivudine for treatment naïve patients, as well as cabotegravir/rilpivirine long-acting injectable for treatment-experienced and naïve patients.”
ViiV Healthcare have applied to the European Medicines Agency (EMA) for approval.
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