HIV-patient reported outcome after switching from single-tablet regimen to dual-tablet regimen

Lotte Ø. Rodkjær3, Inge Bossen1, Carsten S. Larsen2
Affiliates: 1Nurse Specialist, Department of Infectious Diseases, Aarhus University Hospital, Denmark 2Consultant, Associate Professor, Dr.Med., Department of Infectious Diseases, Aarhus University Hospital, Denmark 3Research Nurse, MPH, PhD, Associate Professor, Department of Infectious Diseases, Aarhus University Hospital, Denmark

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Background
According to the Danish Guidelines Tenofovir + emtricitabine + efavirenz (TDF/FTC/EFV) is one of the preferred regimen. The combination can be administered as either a fixed-dose single tablet regimen (STR), Atripla®, two tablets, Truvada®+Stocrin®, or three tablets Viread® + Emtriva® + Stocrin® once-daily. During the last years, there has been much focus on the cost of medicine in Denmark. Therefore the five Danish Regions established a council for the use of expensive medicine (RADS). Although Studies have shown that lower pill burden is associated with higher rates of adherence to HIV treatment and better virological outcomes it was decided politically, that the advantage of STR did not justify a significant additional expenditure and patients receiving TDF/FTC/EFV should receive the cheapest combination.

The aim of this study was to investigate the effect of shifting from a STR to a dual-tablet regiment on
1. Self-reported adherence (VAS)
2. Self-reported treatment preferences of medication (POM) switching back to Atripla®
3. Virological and immunological outcomes among patients switching from Atripla® to Truvada®+Stocrin®.

Methods
The study was conducted in a single Danish HIV center from April 2011 to April 2012. All patients who received Atripla® and were switched to Truvada®+Stocrin® and back were included in the study. Six months prior to the switch, at baseline (switch to the combination) and 6 months after switching back to Atripla®, self-reported adherence and virologic and immunologic outcomes were evaluated. Self-reported treatment preferences (POM) were conducted after switching back to Atripla®.

Results
Eighty-two patients were receiving Atripla® and 22 continued the STR due to the concerns from health care professionals about adherence. Among the 60 HIV-infected individuals on Atripla who switched to Truvada®+Stocrin®, 45 (75 %) switched back on Atripla®. Fifteen (25 %) switched to other combinations due to CNS side effects to EFV (12), treatment failure (1), pregnancy wish (1) and nephrectomy (1). Eviplera® was prescribed for nine of the patients with CNS side effects.
There were no significant changes in self-reported adherence (>95%), virologic and immunologic outcomes during the relatively short study period. However 58% of patients reported that the multi-tablet regimen was “slightly worse” (25% [n=11]) or “much worse, I much prefer my previous medication” (33% [n=15]).

Conclusion
In this study switching from Atripla® to Truvada®+Stocrin® was not associated with poorer adherence or change in virologic and immunologic outcomes. However, the number of participants is small and the observation period short. The majority (58 %) of the patients prefer the single-tablet regimen versus dual-tablet regimen. These results merits further investigation of the long-term consequences of pill-burden on adherence and efficacy of treatment.