Lead-in or No, Switch to Long-Acting Monthly ART Is Safe

Individuals who have virologic suppression of HIV with daily oral dolutegravir/abacavir/lamivudine (DTG/ABC/3TC) can be switched safely with or without an oral lead-in phase to monthly injectable cabotegravir plus rilpirivine (CAB/RPV) with comparable efficacy and safety, new data suggest.

Among 232 patients who had virologic suppression (HIV-1 RNA less than 50 copies/mL) following 100 weeks of therapy with DTG/ABC/3TC, the safety and tolerability of the long-acting CAB/RPV formulation was similar whether patients were immediately switched to it or transitioned over 1 month with an oral lead-in phase, reported Ronald D’Amico, MD, from ViiV Healthcare, and colleagues during the annual HIV Glasgow drug therapy meeting, which was held virtually this year because of the pandemic.

Virologic suppression rates 24 weeks after the switch were 99.1% for patients switched directly to the long-acting CAB/RPV and 93.4% for patients who had an oral lead-in; virologic data at this time point was not available for 7 patients (5.8%) in the oral lead-in arm vs 0% of patients in the direct-treatment group.

The investigators reported results of the extension phase of the FLAIR trial. In this study, 629 treatment-naive study participants started on DTG/ABC/3TC, and those who achieved viral suppression at 20 weeks, were then randomly assigned to continue with that regimen or to switch to long-acting CAB/RPV. Participants in the switch group began with a 30-day lead-in regimen of daily oral cabotegravir 30 mg plus rilpivirine 900 mg and then switched to monthly intramuscular injections.

In the current study, the investigators reported on the extension switch population. At week 100 of the study, patients initially assigned to DTG/ABC/3TC could opt to switch to intramuscular CAB/RPV either directly (111 patients) or with 1 month of oral CAB/RPV (121 patients).

At 24 weeks following the switch (study week 124), only one patient in each study arm had HIV-1 RNA of 50 copies/mL or greater, and as noted before 99% of patients in the direct-to-injection arm had maintained virologic suppression, as did 93% of patients in the oral lead-in group. One patient in the direct-to-injection arm had a confirmed virologic failure at week 112.

There was one grade 4 drug-related adverse event in the direct-to-injection group, a case of mixed cellularity Hodgkin lymphoma. Severe (grade 3) adverse events occurred in one patient in the direct arm, and five in the oral lead-in group.

Patients generally tolerated the long-acting injections well. Injection site reactions were the most common adverse events reported; most were mild or moderate in severity, the investigators reported.

Long-acting CAB/RPV is an investigational formulation. Last December, the US Food and Drug Administration denied approval to the formulation based on manufacturing and chemistry concerns, according to a company press release.

HIV Glasgow 2020 Virtual Conference: Abstract O414. October 5-8, 2020.

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Want To Sleep Like a Log? 5 Reasons To Switch to a Low Bed Frame Now

Getting good sleep at night is one of the most beneficial things you can do for your health. If that’s a problem, you may have toyed with the idea of buying a new mattress or pillow, but what about taking your mattress closer to the ground?

“Research shows that just changing your sleep system, whether this be your mattress, foundation, bed frame, or bedding, can also improve your quality of sleep and lower stress levels,” says McKenzie Hyde, a certified sleep science coach at Amerisleep.com. “If you have been resting on a higher bed for some time, you may benefit from lowering it or replacing the foundation with a low-profile design.”

Of course, we’re not talking about putting your mattress directly on the floor. Experts advise against this to avoid dust, creepy crawlies, and buildup of mold and mildew (gross). Instead, use a low platform bed to support your mattress, yet allow air to move underneath it.

If you’re tired of restless nights, here are some of the benefits of switching to a low bed frame.

1. Sleep cooler

Photo by MASHstudios

If you get hot while sleeping, being closer to the ground can have you resting in slightly cooler temps.

“Heat rises, as it is less dense than cool air, and the higher up or closer to the roof or ceiling of a closed room you get, the warmer the air,” says Richard Morse. He runs InsideBedroom and works in mattress and bedding sales.

Hyde says the floors in our homes tend to stay cool to the touch, even as the temperature of the air fluctuates.

“When we rest in a cooler, more comfortable position, we are more likely to slip into deep sleep and REM sleep, the two most restorative stages of rest,” says Hyde.

2. Feel more cozy

Photo by Aker Interiors

Sleeping closer to the ground can make you feel more comfortable and cozy in your bed.

“When we are closer to the ground, we tend to feel more connected—not isolated—to our surroundings. This creates a calming, more serene environment that can help us fall asleep quicker and rest peacefully throughout the night,” says Hyde. “Therefore, a low-profile bed may feel cozier and promote more relaxation.”

Your kids and pets will love it, too, since a low-profile bed frame is more accessible—they can jump right in with you. Plus, being closer to the ground means you never have to worry about falling out of bed.

3. Upgrade style to minimalism and modern

Photo by Viesso

By trading your standard bed frame and headboard for a low platform, you’ll be getting a style upgrade to a modern, chic look.

“In terms of decor, a low-profile bed is less bulky and gives a smaller space a more open feel,” says Hyde. “Plus, lower beds have a contemporary, minimalistic look that has become popular over the last several years.”

And you don’t even need a box spring if you get a solid base.

“Platform beds are compatible