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ViiV files two-drug HIV maintenance regimen

SWORD studies show treatment could maintain viral suppression

ViiV Healthcare

ViiV Healthcare has filed its first marketing application for a two-drug regimen that could simplify antiretroviral maintenance therapy for HIV.

The company - majority-owned by GlaxoSmithKline - has filed for approval of a single tablet formulation containing integrase inhibitor Tivicay (dolutegravir) and the active ingredient in Janssen's non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine) in the US and EU.

Typically viral suppression treatment for HIV has involved three or four drugs used in combination, but ViiV has been trying to develop two-drug regimens that can reduce drug exposure and side effects, as well as improve adherence to therapy while maintaining the same level of efficacy.

ViiV is also benefiting from a priority review voucher acquired by GSK for $130m and will use it to cut down the FDA review time to six months, as it tries to bring the new combination to market ahead of a new triplet regimen from Gilead Sciences, its fiercest competitor in the HIV category.

Gilead has just reported the results of four phase III trials of its three-drug combo of new integrase inhibitor bictegravir plus emtricitabine and tenofovir alafenamide, showing non-inferiority to ViiV's fast-growing Triumeq (dolutegravir, abacavir and lamivudine) but not - as it had hoped - a superior profile.

Nevertheless some analysts say Gilead could come to dominate the HIV category with the new product, also expected to benefit from an FDA priority review voucher when it is filed later this year with Leerink suggesting it could reach $10bn at peak. With Triumeq likely to feel the pinch ViiV will be hoping its emphasis on two-drug regimens could keep it on a competitive footing.

To that end the HIV specialist is also trying to simplify the treatment of first-line HIV therapy, and recently started trials of a two-drug regimen for that indication as well. Typically newly-diagnosed HIV patients receive a combination of two nucleoside reverse transcriptase inhibitors (NRTIs) with a drug from another drug class, but ViiV is testing the combination of dolutegravir and NRTI Epivir (lamivudine) in phase III trials.

It is also investigating a dual therapy based on integrase inhibitor cabotegravir and rilpivirine that could be given as a monthly or bi-monthly injection as an alternative to daily doses of tablets.

"We believed that dolutegravir would have the right profile to be a core agent in a two-drug regimen," commented John Pottage, ViiV's chef scientific and medical officer.

"Data from the SWORD studies supported our hypothesis that a two-drug regimen of dolutegravir and rilpivirine could maintain viral suppression and these regulatory submissions mark what may be a step change in HIV treatment."

Article by
Phil Taylor

2nd June 2017

From: Regulatory

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