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GSK’s says depot HIV injection works over three years

The injection could rival Gilead’s single-tablet therapy

ViiV

GlaxoSmithKline’s bid to develop an alternative to daily dosing of HIV drugs has made further progress, with new data backing the efficacy of a regimen given every four or eight weeks.

Three-year results from the phase 2b LATTE-2 study of cabotegravir and rilpivirine, given by injection, show that the pair kept HIV levels suppressed in 90% of the eight-week doing group and 83% of the four-week group after 160 weeks of treatment, with “good overall tolerability”, according to GSK’s ViiV Healthcare unit.

Moreover, patients in a control arm receiving standard oral antiretroviral therapy (ART) who elected to swap over to the injectable regimen after 96 weeks did so without loss of viral suppression, with viral levels in 97% of the bimonthly dosing group and 100% of the monthly group still under control by the end of the trial.

ViiV’s chief medical officer John Pottage said the new data – which was presented at the HIV Glasgow Drug Therapy meeting in Scotland – “may provide an alternative to daily pills, reducing the number of annual doses from 365 to 12”.

The combination of ViiV’s integrase inhibitor cabotegravir with non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine – a drug already sold by Janssen as Edurant – is just one of the two-drug combinations GSK is hoping will simplify HIV therapy for people with the virus, and reduce exposure to active ingredients in the hope of limiting side effects.

The intention is also to keep the company competitive with arch-rival Gilead Sciences, which was the first company to bring a single-tablet therapy to market and is still the dominant player, but has been losing market share to ViiV over the last few years.

Earlier this year,  GSK won approval for oral two-drug regimen Juluca – based on integrase inhibitor Tivicay (dolutegravir) and rilpivirine – that aims to provide effective control of HIV with a single pill taken once per day. It has since filed another one-tablet duo (dolutegravir and lamivudine) to provide additional options for patients as GSK tries to fend off a strong challenge from Gilead’s new three-drug tablet Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).

Going down the injectable route provides another option to patients, although ViiV and Janssen still have to navigate a phase 3 trials programme. They have three trials on the go – FLAIR, ATLAS and ATLAS-2M – with the aim of getting it to market in 2019 or 2020.

Preliminary data from ATLAS were reported in the summer, showing that monthly dosing matched the efficacy of daily, oral dosing with triple therapy including two nucleoside RTIs, and the ATLAS-2M study will try to repeat that finding with bi-monthly dosing. FLAIR is looking at monthly dosing in treatment-naïve patients who have their virus levels controlled initially using ViiV’s three-drug Triumeq (abacavir/dolutegravir/lamivudine) product.

The overall value of the HIV market is not expected to change dramatically in the coming years, according to GlobalData, although it suggests there will be a shift towards greater use of simpler regimens and the top-selling products will change.

Anaemia drug filing nears

Meanwhile, GSK had more positive pipeline news this week when it reported positive phase 3 results with daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, as a potential treatment for anaemia associated with chronic kidney disease.

The new data, from the second of three pivotal trials intended to support a marketing application in Japan, showed that the drug was as effective as intravenous treatment with long-acting red blood cell stimulator Aranesp (darbepoetin alfa). GSK says it remains on track to file for approval of daprodustat in Japan – likely to be the drug’s first world market – next year.

Two pivotal studies in the US and Europe are also on the go and are expected to generate results in 2020.

Article by
Phil Taylor

30th October 2018

From: Research

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