FDA NewsPerspective

FDA approves first two-drug HIV regimen, Juluca

Today, the FDA announced the approval of Juluca — the first complete HIV regimen in the United States to include only two drugs instead of three or more.

Juluca (ViiV Healthcare) is a once-daily, single-tablet regimen containing Tivicay (dolutegravir, ViiV Healthcare) and Edurant (rilpivirine, Janssen). It is approved for use in virally suppressed adults on a stable ART regimen for at least 6 months with no history of treatment failure.

“Juluca provides a two-drug maintenance regimen for select individuals who are virologically suppressed. This group of select individuals will clearly benefit from this once-daily [nucleoside reverse transcriptase inhibitor]-sparing regimen,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “As we recognize World AIDS Day 2017, we are also aware that this approval represents a paradigm shift in the treatment of HIV-infected patients.”

The approval was based on data from two identically designed clinical trials, SWORD 1 and SWORD 2. The studies included 1,024 patients who were randomly assigned to switch to the dolutegravir/rilpivirine regimen (n = 513) or continue treatment with their current ART regimen (n = 511).

At 48 weeks of treatment, 95% of patients in each group achieved viral suppression with HIV-1 RNA of less than 50 copies/mL (treatment difference = –0.2%; 95% CI, –3% to 2.5%). The proportion of patients with virologic failure was 0.6% in the dolutegravir/rilpivirine group and 1.2% in the control group (treatment difference = –0.6%; 95% CI, –1.7% to 0.6%). The most common adverse events that patients receiving dolutegravir/rilpivirine reported were diarrhea (2%) and headache (2%).

As a result of this approval, the FDA updated labels for Triumeq (abacavir/dolutegravir/lamivudine; ViiV Healthcare) and Tivicay to include data from the SWORD trials and information on the risks for hepatotoxicity, loss of virologic response due to drug interactions and other adverse events associated with dolutegravir-containing regimens.

Disclosure: Birnkrant reports no relevant financial disclosures.

Today, the FDA announced the approval of Juluca — the first complete HIV regimen in the United States to include only two drugs instead of three or more.

Juluca (ViiV Healthcare) is a once-daily, single-tablet regimen containing Tivicay (dolutegravir, ViiV Healthcare) and Edurant (rilpivirine, Janssen). It is approved for use in virally suppressed adults on a stable ART regimen for at least 6 months with no history of treatment failure.

“Juluca provides a two-drug maintenance regimen for select individuals who are virologically suppressed. This group of select individuals will clearly benefit from this once-daily [nucleoside reverse transcriptase inhibitor]-sparing regimen,” Debra Birnkrant, MD, director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said in a press release. “As we recognize World AIDS Day 2017, we are also aware that this approval represents a paradigm shift in the treatment of HIV-infected patients.”

The approval was based on data from two identically designed clinical trials, SWORD 1 and SWORD 2. The studies included 1,024 patients who were randomly assigned to switch to the dolutegravir/rilpivirine regimen (n = 513) or continue treatment with their current ART regimen (n = 511).

At 48 weeks of treatment, 95% of patients in each group achieved viral suppression with HIV-1 RNA of less than 50 copies/mL (treatment difference = –0.2%; 95% CI, –3% to 2.5%). The proportion of patients with virologic failure was 0.6% in the dolutegravir/rilpivirine group and 1.2% in the control group (treatment difference = –0.6%; 95% CI, –1.7% to 0.6%). The most common adverse events that patients receiving dolutegravir/rilpivirine reported were diarrhea (2%) and headache (2%).

As a result of this approval, the FDA updated labels for Triumeq (abacavir/dolutegravir/lamivudine; ViiV Healthcare) and Tivicay to include data from the SWORD trials and information on the risks for hepatotoxicity, loss of virologic response due to drug interactions and other adverse events associated with dolutegravir-containing regimens.

Disclosure: Birnkrant reports no relevant financial disclosures.

    Perspective
    Andrew M. Hill

    Andrew M. Hill

    The FDA approval of dolutegravir/rilpivirine is only for a highly selected group of patients whose virus is currently suppressed on a stable regimen for at least 6 months, with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

    This is the most restrictive FDA approval of any treatment for HIV-1 over the past 25 years. It is not clear whether this two-drug combination will also be safe and efficacious in patients who do not meet these strict criteria. There are many cases of similar two-drug treatments showing inferior efficacy in other patient populations, such as first-line treatment or patients with failure on previous treatments. 

    • Andrew M. Hill, PhD
    • Senior visiting research fellow Department of translational medicine University of Liverpool

    Disclosures: Hill reports no relevant financial disclosures.