Maintenance Regimen of Injected Cabotegravir + Rilpivirine Advances Through Study
April 5, 2016
At the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, early results from the LATTE-2 study were presented on a maintenance regimen of cabotegravir + rilpivirine given by injection every 4 or 8 weeks. Cabotegravir is an experimental integrase inhibitor while the oral version of rilpivirine is an FDA-approved NNRTI. So far, this 2-drug maintenance regimen appears to suppress viral load as well as other standard 3-drug oral regimens.
HIV drugs have become easier to take over the years -- from people taking dozens of pills in the 90s to now often being able to choose from one of six (soon to be seven) daily single tablet regimens. The next step in this evolution is the development of long-acting injectable drugs ... very similar to other commonly injected medications like Boniva to prevent osteoporosis. If the LATTE-2 injected regimen works as well as standard oral regimens, then getting an injection once every 30 or 60 days might improve adherence for those who don't mind getting them.
The planned 96-week study enrolled 309 people who had never taken HIV meds. Average CD4 count was 489 and average viral load was around 80,000 (about 1 in 5 had viral loads >100,000). Average age was 35 years and about 4 out of 5 were white. The great majority was men. No one with hepatitis B or reduced kidney function (<50 CrCl) were included.
Everyone started with a regimen of oral cabotegravir and abacavir/lamivudine (Epzicom) for 20 weeks. (This first period of oral cabotegravir allows for immediately stopping the medication if there are side effects, in contrast to the very long presence of the drug in the body from its long-acting form.) At week 20, participants added oral rilpivirine.
Then, only those who had viral loads <50 copies (91%) at end of week 24 moved on. Two-fifths were randomized to switch to a loading dose of long-acting injected cabotagravir and rilpivirine, followed by injected maintenance doses of 400mg cabotegravir LA plus 600mg of rilpivirine every 4 weeks. Another two-fifths received two loading doses, followed by injections every 8 weeks of 600mg cabotegravir LA plus 900mg rilpivirine LA. Injections were given in the butt muscle. The remaining one-fifth continued on the all-oral regimen
At 32 weeks, 95% of those receiving long-acting injections every 8 weeks and 94% of those injected every 4 weeks had viral loads <50 copies, compared with 91% of those who stayed on the oral regimen. For those who did not respond to any of these regimens, none developed resistance.
Most common side effects for the oral regimen were nausea (9%), indigestion (3%), headache (3%) and fatigue (3%). Reported side effects for the injections were mostly injection site reactions in almost everyone (about 9 out of 10), with 67% reporting pain, 7% swelling and 6% nodules. The great majority of these were mild to moderate in nature, lasting on average about 3 days but sometimes up to a week. They became less common over time but two people stopped the injected regimen because of the reactions.
Other reported side effects from the injections included flu-like symptoms (20%), headache (14%), diarrhea (12%) fever (3%) and fatigue (3%). Nine people stopped the study due to side effects. Lab abnormalities occurred in 16% of those getting the injections and 14% of those on the oral regimen.
D Margolis, et al. "Cabotegravir + Rilpivirine as Long-Acting Maintenance Therapy: LATTE-2 Week 32 Results". 2016 CROI, Boston, MA.
This article was provided by Project Inform. It is a part of the publication The 23rd Conference on Retroviruses and Opportunistic Infections. Visit Project Inform's website to find out more about their activities, publications and services.
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