RISK FACTORS OF ANTIRETROVIRAL TREATMENT FAILURE AMONG ADOLESCENTS IN IMO STATE

                                                            CHAPTER ONE

INTRODUCTION

1.1 BACKGROUND

Among many factors, Antiretroviral Therapy (ART) contributes significantly to change in the natural course of Human Immune Virus infection/Acquired Immune Deficiency Syndrome (HIV/AIDS) since its introduction in 1987.^1-3Rather than its known short course to death in some individuals, ARTs have, as a matter of fact, transformed HIV/AIDS to a chronic disease with increasing potential for survival of cases.⁴ However, if unchecked ART treatment failures can reverse the progress so far recorded toward the pre-ART era resulting in increase in morbidity, mortality and demand for second-line and the salvage drugs.^5-7 Of concern too is that a small proportion of strict adherers fail on therapy especially among those on unboosted protease inhibitors.^8,9

Generally, the adolescents (10-19 years) constitute an integral percentage of people living with HIV/AIDS (PLWHA).^10-13 This subpopulation of PLWHA possess inherent and circumstantial factors that can affect their capacities not to succeed while on therapy .Such risk factors include: age, social economic status, peer influence, disclosure dilemma, risky cognitive and sexual behaviours, discrimination and stigmatization, gender disequilibrium on the adolescent girl, poor adherence, loss to follow up, treatment interruption and infection with HIV resistance strains before initiation of therapy.¹⁴ The health care system challenges may also drive treatment failure.¹⁵

Treatment failure to first line regimen is a negative treatment outcome, could be one or a combination of virological, immunological or clinical. ¹⁶ When PLWHA fail with first line therapy the main life-saving option becomes second line drugs. ¹⁷ Second line and salvage antiretrovirals (ARVs) are replete with pills burden, drug toxicity, increase frequency of clinic visits, potentials for another failure, drug stock out and increased cost of research and ART production. ^{18, 19}

Failing on therapy is fraught with numerous health challenges for the individual and the public. In treatment failure, the risk of morbidity, mortality and poor quality of life is enhanced.²⁰ Since viral suppression is compromised transmission of HIV and maybe the spread of drug resistant strain are promoted in the population.

World Health Organisation (WHO) in 2013 recommended that, virological monitoring of HIV treatment progress is the gold standard.²¹ Nevertheless, low-middle income countries like Nigeria, are yet to adopt this recommendation fully. WHO’s early warning indicators in falling patients is assessed through routine observations of immune and clinical changes as proxy to virological monitoring and predict of HIV drug resistance.^22,23 However, until recently the effectiveness of Prevention of Mother to Child Transmission (PMTCT) Programme in preventing HIV to new-borns was assessed for presence of plasma HIV virus  using infant Dry Blood Spot (DBS) called early infant diagnosis (EID).²⁴  Data for the study of emergence of drug resistance strains and virological failure were collected for this designated subpopulation from which extrapolations were made about the entire population of people living with HIV.

ART treatment failures are significant outcome, and their risk factors are important in the sustenance of the HIV epidemic in the community and in the worsening of the quality of life of those on treatment. It is the determination of these risk factors of treatment failure (using immunological and WHO clinical staging) among adolescents on ART in Imo State that this study aims at.

• STATEMENT OF THE PROBLEM

Worldwide the adolescents make up about 29% of the 4 million young people aged 15-24 living with HIV and the daily number of young people who become infected is rising.²⁵ In spite of the progress made using ART between 2005-2012, the adolescent (10-19 years) remains the subpopulation without a declining figure of AIDS related death in African region.²⁶ The circumstances of adolescent living with the virus are challenging and call for greater attention. The prevalence of immunological treatment failure among ART patients was as high as 17.1% in Tanzania.²⁷ Treatment failure is already a serious threat to ART success, however there are limited studies on children and adolescent who are failing on ART.

The problems of treatment failure among adolescents further derive from multiple perspectives and inadequacies. Foremost is that, it is largely from non-adherence to therapy. Adolescents have a tendency to experiment. They are restive and inquisitive, constantly wanting to find reason why instruction must be obeyed. Or what will happen if I do not? They also lack insight and misjudge consequences of their actions.  Adolescents on ART therefore are more likely than adult and children to refuse to take drugs (ARTs) as prescribed, or refuse to attend clinic and follow up their care. ²⁸

Secondly, our health care system appears not to have recognized the social status of adolescents.²⁹The hospital settings have no provisions for their peculiarities and special health needs. They are neither adults nor children but they are split between the Adult ART and Paediatric clinics. While few studies define adolescence properly^, as (10-19 years), greater proportion of literature defined them as 15- 24 years; (10-25 years); others defined it as children less than eighteen, the results of these works are either under or over-estimate. ²⁹ In some settings the early adolescents (10 – 14) are treated in children’s ARV clinic whereas the 15 – 19 years old are in the adult ART clinic. They receive paediatric dosing on one hand and adult on the other.  In the first case, the paediatric dose may be suboptimal, which is associated with emergence of drug resistance. ³⁰ The second circumstance is that, they will be faced with ART related toxicity from dosing higher than their weight and height most especially where the major assessment is based on age for the transfer to the next clinic in the cascade of treatment. ³¹

Further because adolescents indulge in risky sexual behaviours, they constitute societal risk in the spread of the resistant strains. When resistance to antiretrovirals (ARVs) has occurred to first line regimen, they are to contend with pills burden and the unpleasant experience, closer observation in addition to increased frequency of hospital visits for monitoring and evaluation of adherence. Second-line drug failure is also imminent in those that failed first-line.³² A study produced supportive evidence when they concluded that adherence to first line ART is a predicator of adherence to second-line.³³

Second line drugs are even costlier in terms of research and production.³⁴ This will increase health sector funding to HIV/AIDS control programme, especially during this period of waning donor support and national economic recession.

• JUSTIFICATION/RATIONALE/RELEVANCE OF STUDY

HIV treatment failure constitutes a remarkable risk in the sustenance of individual and community HIV viral load. When the individual viral load is high the potential for transmission is also increased. Because the adolescents are sexually very active they could therefore spread HIV among themselves and the rest of the population. This study is therefore relevant as it will reveals the associated factors relating to adolescent ART failure.

HIV treatment failure has a potential to increase the severity of HIV/AIDS, and to

multiply the death toll caused by HIV/AIDS.  This has the capacity to reverse the success recorded in the fight against HIV epidemic. For the society, this study is significant since it will quantify ART failures and suggest strategies that could take adolescents out failure.

The interest in Adolescents is for the consideration that due to their tendency for risky behaviour, expectation is that they are more likely to default treatment compared to other population of PLWHA. To get the adolescent related predictors of treatment failure and to suggest interventions to enhance their success on treatment may be of great help in the control of morbidity, mortality and spread of HIV.

This study also hopes to fulfil the third element of WHO HIV drugs resistance control strategy: Early Warning Indicator. This is done by keen observation of clinical features to detect early enough, the predictors and time individuals on ART are showing features that are off the course of success.

Generally, adolescents are the underserved and understudied group in the HIV/AIDS response, and till date face worse treatment outcome.^{35, 36} Studies on adolescent in HIV case management are limited in Imo state in comparison to children and adults. This study will contribute to existing evidence by generating data on treatment outcome (failure) in the state.  Subsequently, it will relate factors that influence failure on therapy.  The findings of this work may inform policy makers on areas to review in subsequent revision of policy and guidelines on HIV/AIDS care and treatment for adolescents.

For the case management of adolescents infected with the HIV virus, greater vigilance will be placed on drug treatment and predictors to forestall the emergence of treatment failure.  The providers/prescribers may be better informed on the need to follow treatment guidelines more strictly before substitution or switching to ART second line options.  This could avoid unnecessary and costly second line ARVs.³⁷

The study can identify and help construct link between the determinants and ART treatment failure. Breaking the linkages, as may be recommended at the end of the work, will reduce the risk of disease progression on ART adolescents.

Treatment failure and use of second line drug are costly to public health financing.^37,38 Suppose the issues of treatment failure are addressed, allocations and additional funding for procurement of second line ARTs, for research and logistic maybe minimised. In addition, the estimation of rate of occurrence of treatment failure when supply related will improve accuracy in the drug supply computations. Summarily, community health is improved, the potentials of the growing population is promoted and freed from discomfort and preventable deaths. .

This study could trigger further research; the comparison of the first line ART regimen options with greater risk of failure will lead to further search on specific drug resistant strains of HIV.

• RESEARCH QUESTIONS

1. What is the prevalence of ART treatment failure among adolescent on treatment in Imo State?
2. Does social economic background of an adolescent on ART influence treatment outcome?
3. How does CD4 at start of ART affect treatment outcome among adolescents?
4. What is the relationship between treatment interruption and treatment failure among adolescent on ART?
5. How does poor adherence affect treatment failure?
6. Can improving adolescents’ knowledge of ART treatment outcome reduce treatment failure?

•  GENERAL AND SPECIFIC OBJECTIVES
  • AIM (GENERAL OBJECTIVE)

1. To assess the risk factors influencing first-line treatment failure among adolescents on ART from ART clinics in Imo State.

1.5.2    SPECIFIC OBJECTIVES

1. To determine the prevalence of first line treatment failure among adolescents on ART from selected ART treatment sites in Imo State.
2. To determine the risk factors of first line treatment failure there in.
3. To identify the predictors of treatment failure on the implicated first line regimen.

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