An innovative treatment for HIV, which uses two drugs instead of the normal three, has proved effective in a major clinical trial, in a big boost for its manufacturer ViiV, a division of GlaxoSmithKline.
The trial, called Gemini, could significantly enlarge GSK’s share of the $20bn a year market for HIV treatment, with analysts predicting sales of at least £1.1bn annually by 2025.
Initiated in August 2016, the phase III programme evaluated the safety and efficacy of a two drug regimen of dolutegravir – already a blockbuster franchise for the company, with sales of £5.2bn expected by 2022 – and a second drug, lamivudine, comparing it against a three-drug regimen in HIV-infected adult participants who had not previously had anti retroviral treatment: so-called “treatment naïve” patients.
The two-drug regimen “seeks to address long-term toxicity concerns of people living with HIV by reducing the number of medicines used in their treatment.”
John Pottage, chief scientific and medical officer of ViiV Healthcare, said: “People with HIV are living longer and more productive lives. However, under current standard of care, many patients still take three or more medicines every day.”
The Gemini studies ViiV had undertaken “demonstrate the potency, safety and tolerability of the dolutegravir plus lamivudine combination. They affirm our two-drug regimen strategy, and reinforce our belief that many patients can control their disease with two drugs instead of three or more. Importantly, the studies show that this two-drug regimen could be an option for treatment naïve patients and can support a broad range of patients living with HIV around the world.”
Approximately 1,400 men and women living with HIV were involved in the studies which are being conducted at research centres in Europe, Central and South America, North America, South Africa and Asia Pacific.
ViiV Healthcare said it would now plan for regulatory submissions for the two-drug regimen of dolutegravir and lamivudine later this year.
Interviewed before she had seen the results of the trial, Deborah Waterhouse, head of ViiV, argued that developments including the two-drug regimen would allow it, over time, to take market share from arch rival Gilead.
It would put the company at the forefront of a new treatment model for the disease, she suggested.
The backdrop to the innovation is a transformation in survival prospects for those suffering from HIV.
Ms Waterhouse said that the average life expectancy when the disease was first identified in the 1980s was 18 months but now HIV was “increasingly becoming a chronic condition” in the developed world and the life expectancy of such patients was the same, or even longer, than someone without it, “because of the regular medical checks and the ongoing dialogue with physician, who you’ve probably been with for quite a number of years”.
The prospect of some people taking [the] HIV medicine for 50 or 60 years after diagnosis has spurred the search for drugs that may have fewer side effects and be more readily tolerated over a long period.