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The first two drug HIV therapy today approved by the United States FDA

via:药明康德     time:2017/11/22 16:36:10     readed:1032

HIV is a type of virus that weakens the body's immune system. It can destroy the body's vital immune cells against diseases and infections, seriously affecting the patient's quality of life. According to the U.S. Centers for Disease Control and Prevention (CDC), about 1.1 million people in the United States live with the HIV virus. In certain populations, this virus infection is also an important cause of death.

Juluca, brought by ViiV Healthcare, is expected to be a new treatment for HIV-infected patients. The new drug consists of dolutegravir and rilpivirine. Developed by ViiV Healthcare, Dolutegravir is an HIV-1 integrase strand transfer inhibitor (INSTI) that can be combined with other anti-retroviral therapies to treat HIV-1-infected adults; Rilpivirine consists of Developed by Janssen Sciences Ireland UC, it is a non-nucleoside reverse transcriptase inhibitor (NNRTI).

Molecular Structure of Dolutegravir (left) and rilpivirine (right) (Source: Wikipedia)

The safety and effectiveness of Juluca in adults has been evaluated in two clinical trials. The two studies recruited 1,024 volunteers whose viral infection status has been effectively controlled in current anti-HIV therapies. The volunteers were randomized into two groups, one to continue with current anti-HIV therapy and the other to use Juluca. Studies have shown that Juluca can effectively inhibit the HIV virus, the effect of these volunteers have used anti-HIV therapy.

In terms of side effects, Juluca most often causes diarrhea and headaches. Serious side effects include rashes and allergic reactions, liver problems, and mood changes such as depression. The FDA's bulletin states that Juluca can not be used in combination with other anti-HIV drugs and may react with common drugs.

Juluca offers dual-drug maintenance therapies for those patients whose viruses have been suppressed, and patients in this group will benefit from such a once-daily NRTI-free program.20 World AIDS Day is just around the corner and we are aware that this approval "The treatment paradigm changes for people living with HIV," said Dr. Debra Birnkrant, director of the Antiviral Products Division of the FDA's Center for Drug Evaluation and Research. "Limiting the amount of drug in HIV therapies reduces the toxicity to patients."

There are 10 days is the 2017 World AIDS Day. As this day arrives, we are grateful to the researchers for bringing new treatments to this particular patient group and expecting that this new, more effective and less drug-use treatment will further improve the lives of HIV-infected patients.


[1] FDA approves first two-drug regimen for certain patients with HIV

[2] FDA Approved Juluca to Treat HIV

[3] ViiV Healthcare announces detailed positive phase III results for investigational two-drug regimen of dolutegravir and rilpivirine for HIV treatment

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