Dutch adherence programme boosts HIV Tx success rate

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Dutch researchers have developed an HIV medication adherence programme that has been successful in increasing treatment success rates by almost 18%, claiming it as the first adherence intervention in HIV care that demonstrates clinical and cost effectiveness.

The researchers were from the Universities of Aberdeen, Maastricht and the University and Academic Medical Centre in Amsterdam .

Medical Xpress reports that the study reports that whilst HIV medication does not deliver a cure, it works so well that the life-expectancy of people living with HIV is quite similar to that of healthy people. Patients successfully treated for HIV are also extremely unlikely to transmit the virus to others. However, a significant proportion of people with HIV take their medication too irregularly for it to work well, or discontinue their medication entirely.

Irregular use of the medication – or ‘non-adherence’, means that the virus gets a chance to replicate again and can attack the immune system – potentially leading to Aids. Using a combination of self-management strategies, counselling and patients tracking their own medication use with electronic pill bottles, the study found an increase in treatment success rates of almost 18% compared to patients who received regular care.

Health Psychologists and clinicians from Aberdeen and the Netherlands carried out a trial of their intervention programme on more than two hundred patients over 15 months in 7 hospitals across the Netherlands.

The amount of virus present in the blood, or viral load, was measured before and 3 times after the intervention. If patients had a detectable viral load at two consecutive time points after the intervention, it was labelled as ‘treatment failure’.

The report says results showed a substantial reduction in treatment failure (over 60%) in those who received the intervention, compared to those who had received regular care.

The team also performed an economic evaluation on the intervention and found that as well as improving patients’ quality-adjusted-life-years (the years people life in good health), it was also cost saving. If ten thousand patients would receive the intervention, it would save approximately 5 million Euro and lead to a gain of 340 quality-adjusted-life-years.

Professor Marijn de Bruin from the University of Aberdeen said: “This is the first adherence intervention in HIV care that demonstrates clinical and cost effectiveness. The intervention can be applied in routine clinical care, and the effects have been reproduced in consecutive trials”.

“Although today’s HIV medications are very effective, they can have quite a few side-effects and people with HIV don’t usually experience any symptoms of the disease, so – for these and other reasons – it is unsurprising that adherence among some patients is suboptimal.

“We designed a programme in such a way that it would fit in with routine care and only adds about 10 minutes to the consultation.

“Our intervention has proved to be very successful at improving drug-adherence and in turn reducing treatment failure. Importantly, these effects were most profound amongst patient groups from which we know struggle most with this treatment.

“As well as important for patients’ own health, having a very low viral load means that people are extremely unlikely to transmit the virus to other people. So not only is this a significant improvement to individual patients’ health, it is also important for public health because it may help to curb the pandemic by interrupting the transmission of the virus.

“That the intervention also saved money – rather than required extra resources – was unexpected, and it strongly suggests that introducing this programme in routine HIV care is beneficial for patients and society.

“It is important to note that medication non-adherence is very common with long- and short-term treatments for many conditions, often contributing to poor patient outcomes and increased health care expenditure. We will therefore seek to adapt and test the benefits of this intervention in a range of other chronic conditions.”

Summary
Background: No high-quality trials have provided evidence of effectiveness and cost-effectiveness of HIV treatment adherence intervention strategies. We therefore examined the effectiveness and cost-effectiveness of the Adherence Improving self-Management Strategy (AIMS) compared with treatment as usual.
Methods: We did a pragmatic, multicentre, open-label, randomised controlled trial in seven HIV clinics at academic and non-academic hospitals in the Netherlands. Eligible participants were patients with HIV who were either treatment experienced (ie, with ≥9 months on combination antiretroviral therapy [ART] and at risk of viral rebound) or treatment-naive patients initiating their first combination ART regimen. We randomly assigned participants (1:1) to either AIMS or treatment as usual (ie, containing a range of common adherence intervention strategies) using a computer-generated randomisation table. Randomisation was stratified by treatment experience (experienced vs naive) and included block randomisation at nurse level with randomly ordered blocks of size four, six, and eight. 21 HIV nurses from the participating clinics received three training sessions of 6 h each (18 h in total) on AIMS and a 1·5 h booster training session at the clinic (two to three nurses per session) after each nurse had seen two to three patients. AIMS was delivered by nurses during routine clinic visits. We did mixed-effects, intent-to-treat analyses to examine treatment effects on the primary outcome of log10 viral load collected at months 5, 10, and 15. The viral load results were exponentiated (with base 10) for easier interpretation. Using cohort data from 7347 Dutch patients with HIV to calculate the natural course of illness, we developed a lifetime Markov model to estimate the primary economic outcome of lifetime societal costs per quality-adjusted life-years (QALYs) gained. This trial is registered at ClinicalTrials.gov (number NCT01429142).
Findings: We recruited participants between Sept 1, 2011, and April 2, 2013; the last patient completed the study on June 16, 2014. The intent-to-treat sample comprised 221 patients; 109 assigned to AIMS and 112 to treatment as usual. Across the three timepoints (months 5, 10, and 15), log viral load was 1·26 times higher (95% CI 1·04–1·52) in the treatment-as-usual group (estimated marginal mean 44·5 copies per mL [95% CI 35·5–55·9]) than in the AIMS group (estimated marginal mean 35·4 copies per mL [29·9–42·0]). Additionally, AIMS was cost-effective (ie, dominant: cheaper and more effective) since it reduced lifetime societal costs by €592 per patient and increased QALYs by 0·034 per patient.
Interpretation: Findings from preparatory studies have shown that AIMS is acceptable, feasible to deliver in routine care, and has reproducible effects on medication adherence. In this study, AIMS reduced viral load, increased QALYs, and saved resources. Implementation of AIMS in routine clinical HIV care is therefore recommended.

Authors
Marijn de Bruin, Edwin J M Oberjé, Wolfgang Viechtbauer, Hans-Erik Nobel, Mickaël Hiligsmann, Cees van Nieuwkoop, Jan Veenstra, Frank J Pijnappel, Frank P Kroon, Laura van Zonneveld, Paul H P Groeneveld, Marjolein van Broekhuizen, Silvia M A A Evers, Jan M Prins

Medical Xpress report
The Lancet Infectious Diseases article summary


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