USA green light for Gilead's HIV combo

GSK share price: HIV unit files lawsuit over rival's treatment

Since the introduction of highly active antiretroviral therapy 20 years ago, HIV treatment regimens had predominantly included three antiretroviral drugs.

Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older medication that combines nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide.

In a separate development, ViiV Healthcare has launched a phase 3 trial to evaluate a two-drug regimen of dolutegravir and lamivudine against continued treatment through a tenofovir alafenamide fumarate (TAF)-based regimen in HIV-infected adults who are virologically suppressed and stable on the TAF-based regimen.

Bictarvy is indicated both for adults starting HIV treatment for the first time and for people on treatment with an undetectable viral load who wish to switch to a new regimen that might be more convenient or better tolerated. "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".

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"ViiV Healthcare will seek to prove that Gilead Sciences Inc's triple combination HIV drug containing the HIV integrase inhibitor bictegravir infringes ViiV Healthcare's patent covering ViiV Healthcare's dolutegravir and many other compounds that include dolutegravir's unique chemical scaffold", the company said in statement.

Two studies pitted the two drug combinations head to head, while another two found patients were able to switch from ViiV's drug to Gilead's with no loss of viral suppression. Results from Study 1844 will be presented at an upcoming conference, Gilead said. The new combination offers the smallest INSTI-based, triple-therapy, single-pill regimen available, Gilead says. Through 48 weeks, no participants in any of the four studies failed Biktarvy with treatment-emergent virologic resistance, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome.

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. According to its prescribing information, prior to or when initiating treatment with Biktarvy, health care providers should test for hepatitis B virus (HBV) infection and renal function, and they should monitor renal function as clinically appropriate during therapy.

The Advancing Access Copay Coupon Program, which provides co-pay assistance for eligible patients with private insurance who need assistance paying for out-of-pocket medication costs. They are predicting sales of $10bn thanks to the combination's "convenience, safety and tolerability and efficacy", and they also think Gilead will use an FDA priority review voucher to get the drug to market in the U.S. as quickly as possible.

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