ART drug Juluca appears in European pharmacies
Pharmaceutical company ViiV Healthcare, specializing in the development and production of medicines for HIV treatment, reported that the European Commission issued a permit for the implementation in Europe of the combined drug Juluca.
Juluca is a two drug regimen made up of dolutegravir 50mg [ViiV Healthcare] and rilpivirine 25mg [Janssen Sciences]. It's intended for the treatment of HIV-1 in adults who previously had ART and who have undetectable viral load for at least six months.
To the conditions of use of Juluca, the manufacturer also refers to the absence of contraindications (viral resistance or suspicion) of drugs among drugs from non-nucleoside reverse transcriptase inhibitors or integrase inhibitors.
"The decision of the European Commission for Juluca is very good news for people living with HIV throughout Europe. Now they will have the opportunity to maintain an undetectable viral load using a treatment regimen consisting of only two drugs," - said ViiV Healthcare executive director Deborah Waterhouse.
The decision of the regulator, experts say, will create a new option for treating HIV infection for more than 800 thousand patients throughout Europe.
Commenting on the decision of the European body, the chief scientific and medical officer of ViiV John Pottaj Jr. (John C Pottage, Jr.) noted:
"With the advent of Juluca, we found a way to reduce the number of antiretroviral drugs while preserving the effectiveness of the traditional 3-part regimen. This has already been recognized by the guidelines of the European AIDS Society (EACS 2017), recommending doltegravir and rilpivirin as a "switching" option for patients with undetectable viral load. "
According to a ViiV press release, SWORD research data presented at the Conference on Retroviruses and Opportunistic Infections (CROI) in 2017 and subsequently published in the Lancet magazine showed that the regime of dolutegravir and rilpivirin is not inferior to the traditional three- and four-part regimens of admission ARVT with virological response preserved.
Among the most common side effects of Juluca, developers call nasopharyngitis, headache, diarrhea and upper airway inflammation.
Add that for the drug included in the drug ViiV dolutegravir FDA and the European Medicines Agency (EMA) also recently introduced additional precautions for pregnant women.
The recommendations of regulators, in particular, are based on preliminary findings drawn from the observation of more than 11,000 HIV-positive women in Botswana.
The researchers found that babies born to mothers taking dolutegravir during pregnancy or during the first trimester had a higher risk of neural tube defect in the fetus - 0.9% versus 0.1% in infants born to mothers taking other drugs.