ViiV Healthcare has started phase III trials of a two-drug regimen for HIV that could simplify treatment for patients receiving antiretroviral therapy for the first time.
The HIV specialist intends to run two phase III trials of the combination of its integrase inhibitor Tivicay (dolutegravir) and nucleoside reverse transcriptase inhibitor (NRTI) Epivir (lamivudine), comparing it to a three-drug regimen based on Tivicay and Gilead Sciences’ double NRTI drug Truvada (tenofovir disoproxil fumarate/emtricitabine).
At the moment, the standard approach to first-line HIV therapy is to combine two NRTIs with a drug from another drug class. ViiV wants to see if it is possible to reduce drug exposure and improve adherence to therapy, while maintaining the same level of efficacy, with a two-drug regimen.
Two phase III studies – GEMINI-1 and GEMINI-2 – will enrol approximately 1,400 men and women living with HIV and are being conducted at research centres in Europe, Central and South America, North America, South Africa and Asia Pacific.
“We believe the clinical profile for dolutegravir presents an important opportunity to investigate the possibility of first-line treatment of HIV with a two-drug regimen,” said John Pottage, ViiV’s chief scientific and medical officer.
“With this ambitious phase III programme, we will explore whether this two-drug regimen can fundamentally change the existing HIV treatment strategy, reducing the number of medications and potentially streamlining treatment regimens for people living with HIV.”
The overall value of the HIV market is not expected to change dramatically in the coming years, although there will be a shift towards greater use of integrase inhibitor like Tivicay and Gilead’s Vitekta (elvitegravir) as well as simpler, single-tablet regimens, according to GlobalData.
The market research firm is predicting that the overall HIV market will rise from $14bn in 2013 to $15.3bn in 2023. There will be demand for newer drugs and therapies that require fewer pills to be taken, but GlobalData predicts the market will continue to be held back by low diagnosis rates, increased transmission of the virus and delays in starting therapy.
In addition to the Tivicay/Epivir combination, ViiV is also investigating a dual therapy based on integrase inhibitor cabotegravir and Johnson & Johnson’s non-nucleoside RTI rilpivirine that could be given by monthly or bi-monthly injection as an alternative to daily doses of tablets. It also has an oral dolutegravir/rilpivirine combination in trials and is working on a single-tablet version.
HIV therapies that combine multiple drugs into one tablet such as ViiV’s Triumeq (dolutegravir/abacavir/lamivudine) and Gilead’s Quad product (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) are expected to be key drivers for market growth, according to GlobalData.
However, there are likely to be opportunities for regimens that reduce exposure to the antiretrovirals and can potentially reduce side effects.