ViiV reports positive results in second Phase III trial of long-acting, injectable HIV regimen combining cabotegravir, Edurant

ViiV Healthcare announced data on Tuesday demonstrating that its once-monthly, injectable regimen combining the investigational integrase inhibitor cabotegravir with Johnson & Johnson's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) met the primary endpoint of the Phase III FLAIR trial of patients with HIV-1. Specifically, ViiV said the regimen showed similar efficacy compared to a daily, oral three-drug, integrase-based regimen in virally-suppressed adults. In August, the company reported that the regimen had met the main goal of the late-stage ATLAS trial in HIV-1-infected patients. 

The drugmaker added that it plans to use pooled data from both the FLAIR and ATLAS studies for future regulatory submissions.

The FLAIR study was designed to assess whether the combination maintained virologic suppression in adults who completed 20 weeks of treatment with Triumeq (abacavir/dolutegravir/lamivudine). The results illustrated that cabotegravir plus Edurant had similar efficacy as Triumeq at week 48 as determined by the proportion of patients with plasma HIV-1 RNA levels of 50 copies per mL or more. ViiV noted that overall safety, virologic response and drug resistance results for the injectable regimen were also consistent with data from the Phase II LATTE and LATTE-2 studies.

John Pottage, chief scientific and medical officer at ViiV, remarked "the FLAIR data provide further evidence that a long-acting, injectable [two-drug regimen] of cabotegravir and [Edurant] may offer an alternative to daily, oral therapy for people who have previously achieved viral suppression." He further noted that the new combination "could transform HIV therapy by reducing the number of days a person receives treatment from 365 to 12." ViiV plans to present detailed results from the study at a future research conference. 

ViiV and Johnson & Johnson formalised plans to initiate late-stage development of the combination in 2016. Edurant is already approved in the US for use in combination with other antiretroviral drugs for treatment-naïve patients with HIV. Meanwhile, GlaxoSmithKline, which holds a majority stake in ViiV, with Pfizer and Shionogi as shareholders, previously identified cabotegravir as one of as many as 20 new drugs it hoped to launch before 2020. 

For related analysis, see ViewPoints: ViiV looks to upset the applecart in HIV again.

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