Juluca, the world’s first ever two-drug regimen to fight HIV, has finally been approved by the Food and Drug Association in the United States.
Juluca has been approved as a “complete regimen for the maintenance treatment of HIV-1 infection in adults who are virologically suppressed.” The regimen is advisable for those who do not have any history of treatment failure and “no known substitutions associated with resistance to the individual components of Juluca,” according to the press release from Viiv Healthcare, the global specialist HIV company.
The two-drug regimen is comprised of dolutegravir and rilpivirine, a reverse transcriptase inhibitor.
There are some side effects that are expected to happen for those who will take the drug, but it is reportedly fewer and less harmful than other ones available on the market, per a report from NewNowNext.
The most known side effects were headache and diarrhea. More serious side effects include liver problems, allergic reactions, rash, depression or mood change.
Dr. Debre Birmkrant, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said that Juluca’s approval will help “reduce toxicity for patients.”
Juluca underwent stringent screening by using the drug in clinical trials that included 1,024 participants. The participants were randomly assigned to use an anti-HIV drug and Juluca.
The results show Juluca to be more effective in keeping the virus suppressed compared to the alternative on the market.
The CDC also declared that people who receive consistent treatment could have reduced viral loads, minimizing the risk of virus transfer, according to Mail Online.
Juluca’s approval puts it ahead of its rival, Gilead Sciences. It has lesser effects and its benefits outweigh the risks.
Chief Scientific and Medical Officer at Viiv Healthcare Dr. John C. Pottage said that they took into consideration the medicine intake of a person when innovating the drug.
“Based on the fundamental principle that no one should have to take more medicines than necessary, ViiV Healthcare has put in place a comprehensive 2-drug regimen research and development programme built around the characteristics of dolutegravir. Juluca, our new 2-drug regimen, once-daily, single pill, now provides people living with HIV who are virologically suppressed, the option to reduce the number of antiretrovirals they take, while maintaining the efficacy of a traditional three-drug regimen.”
Juluca is now the first drug to be fully endorsed by the FDA and is considered to have positive effects that improve the life and well-being of those undergoing treatment.
At present, Viiv Healthcare is looking to explore more potentials of Juluca.
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