COMBINE2: A Network Prospective 2DR Cohort Epidemiology Study
Research type
Research Study
Full title
‘COMBINE-2’: Real-world evidence for effectiveness of Two Drug Regimen, Antiretroviral therapy with integrase inhibitors plus a reverse transcriptase inhibitor
IRAS ID
264011
Contact name
Margaret Johnson
Contact email
Sponsor organisation
President of the NEAT ID Foundation
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
In this study, gathering real-world evidence with less restrictive inclusion criteria to evaluate the effectiveness of the two-drug regimen (2DR) for the treatment of HIV aims to improve the quality of information on the safety of 2DR in terms of drug related Adverse Events (AEs) and Serious Adverse Events (SAEs), and to further understand the development of resistance in HIV therapeutics.
This study will assess the effectiveness of an integrase inhibitor, Dolutegravir (an antiretroviral drug designed to block the action a viral enzyme that infects healthy cells), plus a reverse transcriptase inhibitor, Lamivudine (3TC) or Rilpivirine (RPV (an antiretroviral drug that inhibits the activity of reverse transcriptase, a viral enzyme that is required for the replication of HIV), to further demonstrate the value of such regimen.Summary of Results
In the final analysis population, there were 735 patients who were switched whilst virologically supressed, 23 patients for whom 2 Drug Regimen was their first line of treatment, and 16 patients who switched following Virological Failure on their prior regimen.
Among the 735 stable switch patients, there were 10 patients with Virological Failure by week 96, using a threshold of Viral load greater than or equal to 50 copies/millilitre.
Among these 10 events:
• 1 patient experienced 2 consecutive Viral loads greater than or equal to 50 copies/millilitre • 3 patients experienced a single Viral load greater than or equal to 50 copies/millilitre followed by discontinuation of the index 2 Drug Regimen • 6 patients had a single Viral Load greater than or equal to 50 copies/millilitre at the week 96 time point, and were classified as Virological Failure due to missing information after the study end.
Using a threshold of greater than or equal to 200 copies/millilitre to define Virological Failure, there were 3 patients with Virological Failure. There were 39 discontinuations by 96 weeks in the stable switch population. There were 2 drug related Serious Adverse Events, which occurred in 2 patients and included 1 instance of low mood and 1 instance of anxiety and depression. There were no deaths.REC name
West of Scotland REC 4
REC reference
19/WS/0067
Date of REC Opinion
13 Jun 2019
REC opinion
Further Information Favourable Opinion