ViiV prepares another two-drug HIV filing

ViiV Healthcare says it is on course to change standard care in HIV treatment by providing another combination cutting the number of drugs taken to suppress the disease from three to two, following confirmatory late stage results announced this week.

The joint venture between GlaxoSmithKline, Pfizer and Shionogi announced that the GEMINI 1 and 2 studies met their primary endpoint at this year’s AIDS2018 conference, showing the two-drug regimen of dolutegravir and lamivudine was as effective as a three-drug equivalent.

ViiV said it plans to file the two-drug regimen later this year, taking on three-drug regimens from competitors such as Gilead.

It already has a two-drug regimen, Juluca, which was approved in Europe in May, and by the FDA last year.

The studies compared the two drug regimen with dolutegravir and a standard “backbone” of two nucleoside reverse transcriptase inhibitors – tenofovir disoproxil fumarate and emtricitabine, in previously untreated patients with viral loads up to 500,000 copies per millilitre.

By swapping the two-drug backbone with a single dose of lamivudine, an old GSK nucleoside reverse transcriptase inhibitor first approved two decades ago, the companies aim to produce a cocktail that is more patient-friendly.

HIV suppressant drugs are always given in combination, so that they keep working should the virus develop resistance to one of the components.

The GEMINI studies met their primary endpoint based on plasma HIV-1 RNA levels, a standard measure of HIV control, at week 48, showing that the two-drug regimen was as effective as the three-drug regimen.

Drug-related adverse events were less frequent in patients on the two-drug regimen, compared with those on the three-drug regimen, and in each study arm 2% of patients withdrew due to adverse events.

John Pottage, chief scientific and medical officer at ViiV, said: “These data we have presented at AIDS 2018 provide further evidence that we should be rethinking the traditional approach to HIV treatment of using three or more drugs. The results from the GEMINI programme support our belief that the two-drug regimen of dolutegravir and lamivudine can be a valuable option for treatment-naïve patients and that no patient should take more medicine than they need.”

In a separate announcement, ViiV also announced data from the separate SWORD clinical programme, with 100-week data showing its already-marketed two-drug therapy Juluca maintained its efficacy.

Data from the SWORD 1 and SWORD 2  studies showed 89% of patients on Juluca (dolutegravir+rilpivirine) for 100 weeks, maintained viral suppression.

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