Adherence to prescribed antiretroviral therapy in human immunodeficiency virus-infected children in the PENTA 5 trial

Gibb, Diana; Goodall, Ruth; Giacomet, Vania; Mcgee, Laura; Compagnucci, A.; Lyall, Hermione

doi:10.1097/00006454-200301000-00015

Cited by 144 publications

(119 citation statements)

References 13 publications

Supporting

Mentioning

110

Contrasting

Unclassified

Order By: Relevance

“…1,2,6,7,10,[12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31] The interview guidelines (Table 1) contained 4 broad topics: self-report of adherence, factors that influence adherence, assistance in the child's medication intake, and personal perspectives.…”

Section: Methodsmentioning

confidence: 99%

Integrating Adherence to Highly Active Antiretroviral Therapy Into Children's Daily Lives: A Qualitative Study

Hammami¹,

Nöstlinger

Hoerée³

et al. 2004

Pediatrics

View full text Add to dashboard Cite

ABSTRACT.Objective. To acquire a deeper understanding of factors that influence adherence to highly active antiretroviral therapy (HAART) in a pediatric population.Methods. We performed a qualitative study of adherence in children who receive HAART in a Belgian pediatric acquired immune deficiency syndrome referral center. Eleven primary caregivers were interviewed to assess their child's adherence and influencing factors. The interview guidelines were developed on the basis of an extensive literature review. Adherence to treatment was assessed using caregivers' self-report and laboratory results. Content analysis for common items was performed, and statements of adherent and less-adherent patients were compared.Results. Three main factors influenced adherence. Adherent patients were found to internalize the medical information to a stronger extent than less-adherent patients. Adherent patients showed stronger motivation to stick to the medical regimen on the basis of personal cost-benefit analyses, ie, perceived benefits outweighed the costs or difficulties experienced. Adherent patients developed greater problem-solving capacities, ie, ways to deal with practical complications of medication intake. The interviews revealed a fourth, more dynamic component: knowledge, motivation, and capacities evolved in a progressive way, related to individual stages of coping with human immunodeficiency virus (HIV).Conclusions. The data suggest that coping with HIV and the process of establishing good adherence may be interrelated. Caregivers who accept the disease may be more likely to internalize the received information and thus develop a stronger motivation to fight for the child's life. Problem-solving skills sustain this adherence, and medication becomes a priority in the adherent caregivers' daily lives. On the contrary, less-adherent caregivers may be situated at less advanced stages of the coping process. Thus, tailor-made approaches adapted to the individual HIV-related coping strategies need to be developed to improve adherence in children and caregivers. T he introduction of antiretroviral therapy has turned human immunodeficiency virus (HIV) into a chronic, noncurable disease. Highly active antiretroviral therapy (HAART) causes viral suppression and favors immunologic reconstitution, which decreases opportunistic infections, the development of acquired immune deficiency syndrome (AIDS), and mortality. [1][2][3] Nevertheless, achieving and sustaining the required high level of adherence to a treatment regimen to control the disease remains a challenge. Dracup and Melais 4 defined adherence as "the extent to which an individual chooses behaviors that coincide with a clinical prescription achieved through negotiation between the health professional and the patient." In the case of HAART, this suggests introducing multiple, strictly timed doses of several drugs, some with a bad taste, into daily life. Moreover, adherence of Ͼ95% seems necessary to achieve viral suppression and to avoid development of viral resistance...

show abstract

Section: Methodsmentioning

confidence: 99%

Integrating Adherence to Highly Active Antiretroviral Therapy Into Children's Daily Lives: A Qualitative Study

Hammami¹,

Nöstlinger

Hoerée³

et al. 2004

Pediatrics

View full text Add to dashboard Cite

show abstract

“…43,44 Studies have demonstrated better adherence with a twice-per-day (vs 3-times-per-day) nelfinavir regimen, shorter length of time since treatment initiation, and nelfinavir rather than indinavir but not with pill burden or drug toxicity. 18,29,35,36 Pontali 43 cited such factors as the availability and cost of the medications, accessibility of treatment, and health care providers' experience and relationship to the patient as health care system variables that are possibly associated with adherence.…”

Section: Factors Related To Adherencementioning

confidence: 99%

Adherence to Antiretroviral Therapy for Pediatric HIV Infection: A Qualitative Systematic Review With Recommendations for Research and Clinical Management

Simoni

Montgomery

Martin³

et al. 2007

Pediatrics

197

166

View full text Add to dashboard Cite

Although nonadherence to prescribed therapies is widespread, it is particularly problematic with highly active antiretroviral therapy for HIV infection. This review of >50 studies in the area of pediatric HIV infection revealed varying methods for assessing antiretroviral adherence with a wide range of estimates of adherence. Correlates of adherence could be grouped as those relating to the medication, the patient, and the caregiver/family, with many conflicting findings and a lack of theory guiding the research. Only 8 studies, mainly small feasibility or pilot investigations, evaluated highly active antiretroviral therapy adherence interventions in pediatric populations. We conclude with specific recommendations for assessment and clinical management of adherence and discuss directions for future research in this area. KeywordsHIV/AIDS; adherence; compliance; interventions; pediatric Adherence to therapy, or the extent to which a patient's behaviors coincide with medical advice mutually negotiated between the health professional and the patient, is a universal HHS Public Access Author Manuscript Author ManuscriptAuthor ManuscriptAuthor Manuscript challenge with all illnesses and in all age groups. 1 Each year in the United States, 500 000 physicians write 1.8 billion prescriptions involving 55 000 pharmacies. 2 However, many of these prescribed medications are never taken, with rates of nonadherence ranging from 15% to 93%. 3 Among persons with chronic illnesses, nonadherence is especially problematic, occurring in up to 82% of cases. [4][5][6] The effects of nonadherence range from individual disability (eg, unrelieved pain) to global threat (eg, development of treatment-resistant bacteria or viruses). The yearly monetary costs of nonadherence exceed $100 billion. 7Adherence is particularly critical with highly active antiretroviral therapy (HAART) in the treatment of pediatric HIV infection. The data on HAART for pediatric HIV infection, although scarcer than for adults, suggest that medication adherence is a strong predictor of therapeutic impact. 8,9 For example, Wiener et al 10 observed that among children with an HIV-1 RNA viral load (VL) < 10 000, 75% had taken 100% of their medication doses in the previous week, whereas among those with a VL of ≥10 000, only 36% reported taking all of their medication.Despite the benefits of HAART in treating pediatric HIV infection [11][12][13][14][15] and the adverse consequences of nonadherence, adherence is reportedly suboptimal among children. [16][17][18][19][20] It is likely thwarted by multiple barriers 21,22 and complicated because, unlike with many other chronic illnesses, most children who are born with HIV in the United States are ethnic/racial minorities who live in chronic poverty with limited resources and face discrimination, family disruption, substance abuse, and the stressors of life in the inner city. 23 In addition, stigma is greater for HIV/AIDS than other chronic illnesses, which often leads caregivers to conceal the child's diagnosis a...

show abstract

“…19 Impediments to adherence for young people have been broadly categorised into two main groups: problems with medication, such as taste and palatability issues, and adherence difficulties related to social situations. 20 Although there have been considerable attempts to improve drug formulations, thus partly addressing the first impediment, the social dimensions are more complex; interference with daily life recurs as a common theme in assessments of poor adherence in young people.…”

Section: Discussionmentioning

confidence: 99%

“…Jacobsen et al, 24 in a four-arm study of planned treatment interruption ± HIV immunisation, reported viral rebound to > 50 copies/ml following treatment interruption at a median [interquartile range (IQR)] of 15 days for those with a prior planned treatment interruption and 21 (13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30) days for those without a prior planned treatment interruption. Harrigan et al, 35 while assuming a constant rate of viral increase that starts as soon as the patient stops therapy, suggest that many patients stopping therapy (previously suppressed) will have an increase in plasma viral HIV ribonucleic acid (RNA) of about 0.2 log/day and will reach detectable levels (> 50 copies/ml) only within 1-2 weeks of stopping therapy.…”

Section: Antiretroviral Agents Viral Load Rebound and Resistancementioning

confidence: 99%

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial

Butler

Inshaw

Ford

et al. 2016

Health Technol Assess

View full text Add to dashboard Cite

BackgroundFor human immunodeficiency virus (HIV)-infected adolescents facing lifelong antiretroviral therapy (ART), short-cycle therapy (SCT) with long-acting agents offers the potential for drug-free weekends, less toxicity, better adherence and cost savings.ObjectivesTo determine whether or not efavirenz (EFV)-based ART in short cycles of 5 days on and 2 days off is as efficacious (in maintaining virological suppression) as continuous EFV-based ART (continuous therapy; CT). Secondary objectives included the occurrence of new clinical HIV events or death, changes in immunological status, emergence of HIV drug resistance, drug toxicity and changes in therapy.DesignOpen, randomised, non-inferiority trial.SettingEurope, Thailand, Uganda, Argentina and the USA.ParticipantsYoung people (aged 8–24 years) on EFV plus two nucleoside reverse transcriptase inhibitors and with a HIV-1 ribonucleic acid level [viral load (VL)] of < 50 copies/ml for > 12 months.InterventionsYoung people were randomised to continue daily ART (CT) or change to SCT (5 days on, 2 days off ART).Main outcome measuresFollow-up was for a minimum of 48 weeks (0, 4 and 12 weeks and then 12-weekly visits). The primary outcome was the difference between arms in the proportion with VL > 50 copies/ml (confirmed) by 48 weeks, estimated using the Kaplan–Meier method (12% non-inferiority margin) adjusted for region and age.ResultsIn total, 199 young people (11 countries) were randomised (n = 99 SCT group,n = 100 CT group) and followed for a median of 86 weeks. Overall, 53% were male; the median age was 14 years (21% ≥ 18 years); 13% were from the UK, 56% were black, 19% were Asian and 21% were Caucasian; and the median CD4% and CD4 count were 34% and 735 cells/mm3, respectively. By week 48, only one participant (CT) was lost to follow-up. The SCT arm had a 27% decreased drug exposure as measured by the adherence questionnaire and a MEMSCap™Medication Event Monitoring System (MEMSCap Inc., Durham, NC, USA) substudy (median cap openings per week: SCT group,n = 5; CT group,n = 7). By 48 weeks, six participants in the SCT group and seven in the CT group had a confirmed VL > 50 copies/ml [difference –1.2%, 90% confidence interval (CI) –7.3% to 4.9%] and two in the SCT group and four in the CT group had a confirmed VL > 400 copies/ml (difference –2.1%, 90% CI –6.2% to 1.9%). All six participants in the SCT group with a VL > 50 copies/ml resumed daily ART, of whom five were resuppressed, three were on the same regimen and two with a switch; two others on SCT resumed daily ART for other reasons. Overall, three participants in the SCT group and nine in the CT group (p = 0.1) changed ART regimen, five because of toxicity, four for simplification reasons, two because of compliance issues and one because of VL failure. Seven young people (SCT group,n = 2; CT group,n = 5) had major non-nucleoside reverse transcriptase inhibitor mutations at VL failure, of whom two (n = 1 SCT group,n = 1 CT group) had the M184V mutation. Two young people had new Centers for Disease Control B events (SCT group,n = 1; CT group,n = 1). There were no significant differences between SCT and CT in grade 3/4 adverse events (13 vs. 14) or in serious adverse events (7 vs. 6); there were fewer ART-related adverse events in the SCT arm (2 vs. 14;p = 0.02). At week 48 there was no evidence that SCT led to increased inflammation using an extensive panel of markers. Young people expressed a strong preference for SCT in a qualitative substudy and in pre- and post-trial questionnaires. In total, 98% of the young people are taking part in a 2-year follow-up extension of the trial.ConclusionsNon-inferiority of VL suppression in young people on EFV-based first-line ART with a VL of < 50 copies/ml was demonstrated for SCT compared with CT, with similar resistance, safety and inflammatory marker profiles. The SCT group had fewer ART-related adverse events. Further evaluation of the immunological and virological impact of SCT is ongoing. A limitation of the trial is that the results cannot be generalised to settings where VL monitoring is either not available or infrequent, nor to use of low-dose EFV. Two-year extended follow-up of the trial is ongoing to confirm the durability of the SCT strategy. Further trials of SCT in settings with infrequent VL monitoring and with other antiretroviral drugs such as tenofovir alafenamide, which has a long intracellular half-life, and/or dolutegravir, which has a higher barrier to resistance, are planned.Trial registrationCurrent Controlled Trials ISRCTN97755073; EUDRACT 2009-012947-40; and CTA 27505/0005/001–0001.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (projects 08/53/25 and 11/136/108), the European Commission through EuroCoord (FP7/2007/2015), the Economic and Social Research Council, the PENTA Foundation, the Medical Research Council and INSERM SC10-US19, France, and will be published in full inHealth Technology Assessment; Vol. 20, No. 49. See the NIHR Journals Library website for further project information.

show abstract

Adherence to prescribed antiretroviral therapy in human immunodeficiency virus-infected children in the PENTA 5 trial

Abstract: Good adherence with taking prescribed medication was associated with virologic response. Social factors were important in explaining nonadherence.

Cited by 144 publications

References 13 publications

Integrating Adherence to Highly Active Antiretroviral Therapy Into Children's Daily Lives: A Qualitative Study

Integrating Adherence to Highly Active Antiretroviral Therapy Into Children's Daily Lives: A Qualitative Study

Adherence to Antiretroviral Therapy for Pediatric HIV Infection: A Qualitative Systematic Review With Recommendations for Research and Clinical Management

BREATHER (PENTA 16) short-cycle therapy (SCT) (5 days on/2 days off) in young people with chronic human immunodeficiency virus infection: an open, randomised, parallel-group Phase II/III trial

Contact Info

Product

Resources

About