- The US FDA approves the first
two-drug treatment for HIV
- The drug, Juluca is a combination
of two other drugs - dolutegravir and rilpivirine
- Juluca helps maintain the
undetectable viral loads of patients who have already been on a consistent
The US Food and
Drug Administration (USFDA) approved the first two-drug regimen to treat HIV
type 1. The treatment called Juluca can reduce the side effects of current
treatments that combine three or four drugs.
Juluca - Complete
Treatment for HIV Type 1
Juluca is a
fixed-dose tablet that combines two active ingredients previously approved by
the FDA, dolutegravir
, and rilpivirine. The new treatment prevents the HIV virus from making copies of
itself. The drug is available for patients who have already been on a stable
regimen for at least six months.
Juluca is the
first out of three viral two-drug regimens to receive USFDA approval after
successful clinical trials. Studies on Juluca found that patients who
switched to the two-drug regimen from their previous therapy were able to
maintain undetectable viral load even without a third antiretroviral drug.
‘The USFDA approved Juluca, the first complete treatment containing only two drugs to treat certain patients human immunodeficiency virus type 1 (HIV-1)’
People with HIV
receive a standard treatment which involves a number of antiretroviral
therapies that combine three drugs. These therapies can extend and improve the
quality of lives of people with HIV. But, a standard treatment for HIV requires
strict dosage regimen that can cause side effects like nausea, insomnia and may
also damage vital organs like the heart, kidneys, and liver.
treatment for HIV like Truvada may weaken the immune system and increase the
risk of transmitting the HIV if not taken every day at the exact same time. The
benefits of these standard treatments outweigh their risks, but the side
effects have led to the development of innovative therapies like Juluca.
Trials of Juluca
trials of Juluca were conducted to study its safety and efficacy in 1,024
participants whose viral load was suppressed on their current antiretroviral
drugs. The participants were randomly assigned to continue their antiretroviral
treatment or to switch to Juluca. The results showed that Juluca was effective
in maintaining a lower viral load compared to those who continued their
once-a-day combination' provides people living with HIV the option to reduce
the number of antiretrovirals they take, while maintaining the efficacy of a
traditional three-drug regimen," said John Pottage, ViiV's chief scientific
number of drugs in any HIV treatment regimen can help reduce toxicity for
patients," said Debra Birnkrant, M.D., director of the Division of Antiviral
Products in the FDA's Center for Drug Evaluation and Research.
recommended dosage of Juluca is one tablet taken orally, once a day with a meal. One tablet of Juluca contains 50mg of
dolutegravir and 25mg of rilpivirine.
to GlaxoSmithKline Plc's majority-owned ViiV Healthcare. ViiV's drug
dolutegravir is a part of GSK's traditional triple-therapy used to control HIV,
and rilpivirine is a Johnson & Johnson drug.
A Note of
Some of the
common side effects of taking Juluca were diarrhea and headache and serious
side effects include skin rash, allergic reactions, liver problems, depression
and mood swings. Juluca should not be given with other antiretroviral drugs and
it may also have drug interactions with other common medications.
- FDA approves first two-drug regimen for certain patients with HIV - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm586305.htm)