Adherence - taking more than 95% of HAART regularly, on time, and mindful of food or other restrictions - is one of the most important factors in therapeutic success, both short- and long-term. Two studies published in the October 1st issue of the Journal of AIDS confirm that patient education does appear to play a part in the success of treatment, but only when it is continual education rather than a short course at the start of treatment, as first reported here on aidsmap last September.
Researchers at 25 outpatient sites in the US looked at whether four sessions of patient education at the start of a new regimen would make a difference in the effectiveness of a triple NRTI-based HAART that consisted of zidovudine/lamivudine given as one pill twice daily (Combivir) alongside abacavir, also given as one pill twice daily. This so-called HEART (Helping to Enhance Adherence to Antiretroviral Therapy) Study was funded by the manufacturer of all three drugs, Glaxo Smith Kline, and lasted 24 weeks.
Those in the trial had to come from “underrepresented populations”, be either antiretroviral naive or spent less than six months receiving ddC, ddI or d4t, have a viral load between 40 and 100,000 copies/mL, and a CD4 count of 50 cells/mm3 or more. Adherence was tracked using MEMS TrackCaps, which electronically record the time and date that each medication is removed from the bottle.
Out of a total 195 participants, 96 were randomised to receive the four weeks of patient education - focusing on patient empowerment, HIV pathogenesis and treatment, and medication management and adherence - as well as given instructions on how to best take the study drugs, were told about the importance of taking the drugs as prescribed, and how to use the MEMS bottles. The other 99 participants were given the latter information only. The majority of patients in both arms were African American (71%) or Hispanic (21%) and male (65%), with 20% being current injection drug users.
Adherence did not differ between the two groups at any point in the study, with adherence rates of 70% in the patient education arm and 74% in the control arm. The authors suggest several reasons for this: four weeks of education may not have been enough; whilst most patients attended the sessions, few caregivers did, which may have affected outcome; and 24 weeks may have been too short a time to measure success or failure.
Additionally, the simple regimen involved - just two pills twice a day with no food restrictions - may have meant less adherence issues in the first place compared with standard PI- or NNRTI-containing HAART.
Unsurprisingly, given the results of ACTG 5095 study - which showed that zidovudine/lamivudine/abacavir given as one pill (Trizivir) was less effective than the efavirenz-containing arms in the study - 33% of those in the patient education arm and 18% of those in the control arm failed to achieve one of the four viral load criteria set out in the study protocol. A combination of these three NRTIs is currently not recommended for first-line therapy in the current draft BHIVA guidelines.
A second study from France - the Ciel Bleu study - randomised 367 patients receiving a stable antiretroviral regimen for at least three months into two groups: one received a continuing educational programme regarding adherence over 12 months, and the other received the standard of care. The personalised education programme included a diagnosis based on adherence problems, pill boxes and drug-identifying stickers, and at least three one-hour educational sessions over the year. Adherence was measured by self-reported questionnaire.
After six months, a statistically significant difference was seen in adherence between the continuing education group and the control group (+0.25 vs. -0.19, p = 0.025). Adherence continued to be sustained in the continuing education group during the 18 month study, and when the control group began receiving continuing education after one year, a similar rate of adherence was seen by 18 months in both groups.
Although there was no direct impact of the continuing educational programme on CD4 count or viral load, the investigators noted that “a benefit of the health status, based on concordant changes in CD4 cell count and plasma viral load” was found between baseline and six months “in 56% of patients in the experimental group and 50% in the control group.” They conclude that “results from our study should encourage physicians to follow recent guidelines that recommend patient education and adherence monitoring.”
Further information on this website
Interventions to improve adherence - menu of information
Adherence - factsheet
Adherence - patient information series booklet (pdf)
Rawlings MK et al. Impact of an educational program on efficacy and adherence with a twice-daily lamivudine/zidovudine/abacavir regimen in underrepresented HIV-infected patients. JAIDS 34(2): 174-183, 2003.
Goujard C et al. Impact of a patient education program on adherence to HIV medication JAIDS 34(2): 191-194, 2003.