GSK's ViiV JV Files Patent Infringement Claim Against Gilead

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"In addition, the clinical data show that the regimen's antiviral efficacy, tolerability profile and limited drug interactions offer an effective new treatment option for a range of people living with HIV".

ViiV Healthcare has just started a clinical trial to test if its two-drug regimen for HIV can work as well as current three-drug HIV treatment.

Three of the ongoing studies are created to explore the efficacy and safety of BIC/FTC/TAF compared to triple-therapy regimens containing dolutegravir; two in treatment-naïve patients and one in virologically suppressed patients switching from an existing DTG-containing antiretroviral regimen.

The company said the phase III study was created to establish if adults with HIV-1 - with current virologic suppression on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs - are able to maintain viral suppression upon switching to a two-drug regimen of dolutegravir (TIVICAY) and lamivudine (EPIVIR). The trials are comprised of a diverse population of 2,415 participants, including a wide range of adult age groups and races/ethnicities.

The company said the TANGO trial was created to demonstrate the non-inferior antiviral activity of switching to dolutegravir and lamivudine compared to continuation of a TAF-based regimen over 48 weeks in virologically suppressed subjects. The most common adverse reactions in patients taking the new medication were diarrhea, nausea, and headache.

The TANGO study follows the GEMINI studies' investigation of the 2DR of dolutegravir and lamivudine in treatment-naïve patients with HIV-1.

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A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor. Results from Study 1844 will be presented at a scientific conference in 2018.

Gilead, in an emailed statement, said it remained "steadfast in our opinion that Biktarvy does not infringe ViiV's US patent, and that the court challenge did not affect the USA availability of the drug. We continue to invest in research in next-generation treatments, including therapies that could potentially cure HIV patients", said John F. Milligan, PhD, Gilead's President and Chief Executive Officer. The new combination offers the smallest INSTI-based, triple-therapy, single-pill regimen available, Gilead says.

FDA approval of Biktarvy was based on data from four on-going phase 3 clinical trials.

Biktarvy does not cure HIV infection or AIDS.

Access to representatives who can provide information related to coverage and insurance-related questions.

A GSK spokeswoman Sarah Spencer told Reuters that the HIV division was seeking 'financial redress, ' but is not asking for an injunction against sales of Gilead's Biktarvy.

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