Adoption of Multi-class Fixed Dose Combination Once-daily Single Tablet HIV Regimen in Europe

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Once-daily multi-class fixed dose combination (FDC) once-daily single tablet regimen (STR) is critical part of antiretroviral treatment armamentarium to manage patients with human immunodeficiency virus (HIV). Multi-wave retrospective medical chart reviews of HIV patients were conducted in Europe (5EU: UK/France/Germany/Italy/Spain) between 1Q2009 and 1Q2015 among patients initiating or switching HIV regimen. Over 1Q2009-1Q2015, 200 physicians abstracted an average of 3000 patient charts per quarter. STR prescribing trends increased in 5EU over the years: 1Q2009- 17%, 1Q2010/1Q2011-23%, 1Q2012-24%, 1Q2013-30%, 1Q2014-44%, 1Q2015-53%. The top reasons for switching from conventional antiretroviral regimen dosing to an STR in 1Q2009/1Q2015 were simplification (74%/64%), tolerability (14%/19%), and patient decision (12%/18%). These observed trends may emphasize the importance HIV providers have given towards maintaining HIV patients on a simple and yet tolerable regimen with the hope to achieve optimal adherence and clinical outcomes over the longer term.

Human Immunodeficiency Virus (HIV) continues to be a major global public health issue, having claimed more than 34 million lives so far. In 2014, approximately 1.2 million people died from HIV-related causes globally. There is no cure for HIV infection. However, effective antiretroviral (ARV) drugs can serve as effective treatment to control disease progression among those with HIV, as well as to help prevent transmission so that people with HIV, and those at substantial risk, can have healthy and productive lives. The World Health Organization (WHO) has advised countries to consider in-country combination ARV therapy costs and has encouraged implementation of public health approaches to scaling up quality HIV care and treatment and simplifying and standardizing ARV regimens.

Single tablet regimens (STR) incorporate fixed dose combinations (FDC) of multi-class drugs into a single dosing unit that is administered once daily. Studies have suggested that HIV patients treated with once-daily fixed dose STRs are more adherent compared to patients on ≥ 2 pills per day regimens, higher perceived quality of life (QoL) and lower costs to healthcare system, while STRs may also provide long-term durability, allowing for continued immunological recovery and increased life expectancy. A number of STRs are already being marketed globally and a few new ones are under development. As new STRs become available, examining how STR prescribing trends have evolved in key markets and what has motivated physicians to switch HIV patients from conventional ARV regimen dosing to STRs could inform future evidence generation and messaging needs and corresponding positioning of STRs to benefit patients and other healthcare stakeholders.

The study was a multi-country, multi-wave, multi-center retrospective medical chart review of adult (≥ 18 years) HIV patients conducted in the 5EU. Data was collected every quarter (Q) of the year since 2005. Physicians were sampled in each of the countries using online physician panels to attain a geographically representative sample in respective regions. Invitations to participate in research were sent to a random set of physicians in the existing online physician panels. The physicians representing both hospital-based and private practices in each geography, personally responsible for choosing and prescribing ARV treatment for patients with HIV, and treating a minimum of 15 HIV patients per month and having 3-35 years of clinical practice experience were screened for study participation. Each physician reported de-identified anonymous data on patients who recently initiated or switched ARVs as part of usual care within the defined study observation windows (for each wave/Q). An electronic data collection form was used to collect the following data elements from eligible HIV patient charts: patient demographics, comorbidities laboratory values (e.g., Viral Load and CD4+ cell count), HIV treatment patterns/dynamics and reasons for therapy initiation/change. Only de-identified anonymous data was collected from the patient charts by the treating physicians. This mode of data collection method met the criteria for local ethics review exemption per the respective physician/site requirements in the EU5.