Prevalence of and risk factors associated with treatment failure among HIV positive adult patients on Dulotegravir based regimen at Nsanje district,
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Date
2021-10-18
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Kamuzu University of Health Sciences
Abstract
The study will aim to determine the prevalence and risk factors associated with the treatment
failure among HIV positive adult patients (15-64) on Dolutegravir (DTG) based regimen at Nsanje
district.
DTG has been a major breakthrough in the management of HIV. In 2013 the USA Food and Drug
Administration (FDA) approved DTG (an integrase inhibitor) to be used as a first line drug of
choice(1). In the late 2017, the drug was available in low and middle income countries (LMIC) as
a stand-alone generic formulation. It was only at the beginning of 2018 when fixed dose
combinations (FDC) of the drug were tentatively approved by the FDA and the European
Medicines Agency (EMA)(2). A good example of a FDC is 13A which comprises of Tenofovir
(TDF)/Lamuvidine(3TC)/Dolutegravir(DTG).
DTG is a drug of choice as it has high potency, good tolerability and low cost(3). The drug also
has good ability to withstand resistance and less side effects compared to the previous drugs which
consisted of the non-nucleoside reverse transcriptase inhibitors Efavirenz (EFV) and Nevirapine
(NVP). Despite that, mutation of the HIV and other factors such as poor adherence, inevitably will
lead to treatment failure development among HIV positive people on DTG based regimen. A study
was carried out to determine the HIV drug resistance and treatment failure against the strand
transfer integrase inhibitors Raltegravir (RAL), Elvitegravir (EVG), and DTG(4). While resistance
which contributes to failure was determined in RAL and EVG it was not ascertained in DTG hence
the need to conduct such a study to discover the same.
Objectives
Broad Objective
To explore the prevalence, socio-demographic and patient comorbidity factors associated with the
treatment failure among HIV positive adult patients (15-64) on Dolutegravir based regimen at
Nsanje district. Specific Objectives
1. To calculate the prevalence of treatment failure among adult HIV patients on DTG based
regimen.
2. To establish socio-demographic factors associated with treatment failure among adult HIV
patients on DTG based regimen
3. To determine patient comorbidity factors associated with treatment failure among adult
HIV patients on DTG based regimen.
Methodology
This study will use a cross sectional design to determine the prevalence of treatment failure and a
retrospective cohort design to determine the socio-demographic factors associated with the
treatment failure among patients on DTG based regimen. Data will be collected by following
patients from January 2018 to December 2020. Treatment failure in the study, will be defined as
the presence of a WHO stage 3/4 condition (clinical), a CD4 of less than 200 cells (immunological)
and/or a viral load of greater than 1000 copies (virological). Factors that contributed to the
treatment failure will also be determined by collecting and assessing the obtained social
demographic and patient comorbidity secondary data from the patient files and Antiretroviral
(ART) registry. Open Data Kit (ODK) platform will be used to form a database of patient
comorbidities and socio-demographic variables. The variables of interest will be entered into
tablets and the data will be routed to a server. ODK has been chosen because it will be programmed
to check for errors before data is sent to the server and this will act as quality control measure to
ensure high quality data is entered and analysed. STATA Version 16.0 software will be used to
analyze the collected data. Microsoft Excel or Tableau will be used to come up with graphs at the
analysis phase. Descriptive statistics, univariate and bivariate analysis will be done during the
analysis phase. Logistic regression will be used to analyze predictors of the outcome variable,
treatment failure. Expected findings and dissemination
The study will determine the prevalence of treatment failure among adult HIV positive patients on
DTG based regimen in Nsanje District. The expected prevalence might be lesser, greater or equal
to 13%, which was a prevalence of treatment failure that was found out in another study done in
Ethiopia(5). The study in Ethiopia found out that the prevalence of treatment failure among those
who were on DTG based regimen was 13%. Factors associated with treatment failure will also be
determined. The study results will be shared with the College of Medicine Research Ethics
Committee (COMREC), the College of Medicine library, Nsanje District Commissioner and
Nsanje District Hospital Management Team (DHMT). Presentation of the study findings will also
be done at international conferences and published in peer reviewed journals for further scrutiny
and a contribution to the research fraternity.
Description
Keywords
Research Subject Categories::MEDICINE