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Adverse Events During ART and Implications for Treatment: Key Data From Summer 2021
  • CME
  • CE

Eric S. Daar, MD
Released: September 22, 2021

Tolerability With New Therapies

FLAIR Week 124: Long-Acting Cabotegravir Plus Rilpivirine for Treatment-Naive PWH

Beyond the metabolic effects we examined in the previous studies, other important AEs may emerge with new therapies. An important example of a novel therapy is the regimen with long-acting cabotegravir and rilpivirine recently approved in the United States.

Among the registrational trials that led to this approval was the open-label FLAIR study of treatment-naive PWH who first achieved stable viral suppression with DTG/abacavir/3TC and who were then randomly assigned to switch to the long-acting regimen vs remaining on the induction regimen.12 At IAS 2021, the investigators presented 124-week follow-up data from 283 participants who were originally randomized to the long-acting cabotegravir plus long-acting rilpivirine arm, and I’d like to review the safety data here.13

I will not go into details on the virologic efficacy at Week 124, but know that virologic suppression was maintained at high levels with this every-4-week regimen.

FLAIR: Week 124 Injection Site Reactions

For this long-acting injectable regimen, the AEs of greatest interest have been the injection site reactions. As shown, a substantial percentage of participants had grade 1/2 injection-site reactions at the first injection. The grade 2 events declined quickly after the first injection at baseline and 4 weeks. After this, grade 1 reactions continued at a relatively low and stable levels out to 124 weeks, occurring in approximately 20% of participants.

The table describes some of the details, including the total number of injections (>17,000) and injection site reaction events (3732).

Pain was the most common symptom, occurring in 18% of injections. However, more significant—perhaps more sustained—reactions such as nodules and induration occurred in fewer than 1% of injections.

The fact that these injection site reactions were reasonably well tolerated and accepted is reflected in the small percentage of study participants who withdrew because of these AEs (2%). This information is extremely important to share with our patients who are looking to start this new novel treatment strategy.

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