ViiV Healthcare submits European, US filings for two-drug HIV maintenance treatment regimen

GlaxoSmithKline and ViiV Healthcare announced that marketing applications for a single-tablet, two-drug regimen combining the integrase strand transfer inhibitor Tivicay (dolutegravir) and Johnson & Johnson's Edurant (rilpivirine) for the maintenance treatment of HIV-1 infection have been submitted in Europe and the US. The companies indicated that a priority review voucher, which GlaxoSmithKline recently acquired for $130 million, was submitted to the FDA along with the filing.

According to the companies, the submissions are based on data from the SWORD-1 and SWORD-2 studies, which, as reported in December last year, met their primary endpoints. The trials investigated switching virologically suppressed patients with HIV from a three- or four-drug antiretroviral regimen to a two-drug regimen of Tivicay and Edurant, with results showing non-inferiority at week 48.

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John C Pottage, chief scientific and medical officer at ViiV, commented "traditionally, we have used a regimen of three or more drugs to maintain HIV viral suppression," adding "data from the SWORD studies supported our hypothesis that a two-drug regimen of [Tivicay] and [Edurant] could maintain viral suppression and these regulatory submissions mark what may be a step change in HIV treatment."

In 2014, ViiV, which is majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, entered a deal with Johnson & Johnson to investigate the potential of combining Tivicay and Edurant in a single tablet. For further analysis, read ViewPoints: ViiV shows it can fight in the trenches.

In February, Gilead Sciences announced mid-stage study results demonstrating that its experimental integrase strand transfer inhibitor bictegravir achieved high virologic response rates similar to Tivicay in treatment naïve, HIV-1 infected adults. More recently, Gilead reported that four late-stage studies investigating a fixed-dose combination of bictegravir and the company's Descovy (emtricitabine/tenofovir alafenamide) for the treatment of HIV-1 infection met their main goals of non-inferiority.

For related analysis, see ViewPoints: Gilead banking on ‘good enough’ being good enough with bictegravir.

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