The phase 3 FLAIR (First Long-Acting Injectable Regimen) study has met its primary endpoint of showing similar efficacy of an investigational monthly injected 2-drug regimen compared with a daily, oral 3-drug regimen in virally-suppressed adults with HIV, according to a statement from ViiV Healthcare. The results were presented at the HIV Glasgow Drug Therapy Meeting, which was held October 28-31, 2018 in Glasgow, Scotland.
“The FLAIR data provide further evidence that a long-acting, injectable 2DR of cabotegravir and rilpivirine may offer an alternative to daily, oral therapy for people who have previously achieved viral suppression,” said John C. Pottage, Jr., MD, Chief Scientific and Medical Officer of ViiV Healthcare in a statement.
FLAIR is a phase 3 randomized, open-label, multicenter parallel group, non-inferiority study designed to assess the antiviral activity and safety
of cabotegravir and rilpivirine in virologically suppressed adults living with HIV following 20 weeks of induction therapy with ABC/DTG/3TC (Triumeq.) The regimen demonstrated the ability to maintain the level of virologic suppression at Week 48.
Cabotegravir is being developed by ViiV Healthcare as a long-acting formulation for intramuscular injection and as a once-daily oral tablet for use as a lead-in to establish the tolerability of cabotegravir prior to long-acting injection. The investigational integrase
rilpivirine is approved by the US Food and Drug Administration (FDA) and is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used for the treatment of HIV in combination with other antiretroviral agents in treatment-naïve adult patients (with a viral load of <
100,000 HIV RNA copies/mL). Long-acting rilpivirine is not approved by regulatory authorities anywhere in the world.
FLAIR is the second phase 3 trial to examine the safety and efficacy of monthly dosing of injectable formulations of cabotegravir and rilpivirine and showed that the long-acting regimen, when injected once monthly had similar efficacy to ABC/DTG/3TC at Week 48 based on the proportion of participants with plasma HIV-1 RNA >
50 copies per milliliter.
Overall, safety, virologic response and drug resistance results for the injectable regimen were consistent with results from both the phase 2 LATTE and LATTE-2
studies. Further details about the results of the FLAIR study will be announced at an upcoming scientific meeting.
In August, ViiV reported positive data from the ATLAS (Antiretroviral Therapy Acting Suppression) study which compared a long-acting, injectable regimen against the continuation of current daily oral antiretroviral therapy in virologically-suppressed, treatment-experienced patients.
ViiV plans to use pooled data from the FLAIR and ATLAS studies for future regulatory submissions.
ABC/DTG/3TC has a boxed warning of hypersensitivity reactions and exacerbations of the hepatitis B virus. Patients with a prior hypersensitivity reaction to abacavir or who carry the HLA-B*5701 allele are at an increased risk of experiencing a hypersensitivity reaction.
Side effects associated with rilpivirine include depression, headache, insomnia, and skin rashes. Hepatic adverse events have been reported and patients with underlying disease including hepatitis B or C may be at an increased risk. Redistribution and/or accumulation of body fat have been observed as well as autoimmune disorders including Graves’ disease, polymyositis, and Guillain-Barré syndrome.
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