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Determinants of Virological Failure Among Adults on First Open access Original research BMJ Open: first published as 10.1136/bmjopen-2019-036223 on 26 July 2020. Downloaded from Determinants of virological failure among adults on first- line highly active antiretroviral therapy at public health facilities in Kombolcha town, Northeast, Ethiopia: a case–control study Habtamu Mengist Meshesha,1 Zelalem Mehari Nigussie ,2 Anemaw Asrat,2 Kebadnew Mulatu2 To cite: Meshesha HM, ABSTRACT Strengths and limitations of this study Nigussie ZM, Asrat A, et al. Objective To identify determinants of virological Determinants of virological failure among HIV- infected adults on first- line highly ► Two consecutive viral load measurements were failure among adults on first- active antiretroviral therapy at public health facilities in line highly active antiretroviral considered, avoiding misclassification of HIV treat- Kombolcha town, Northeast, Ethiopia, in 2019. therapy at public health ment failure. Methods An unmatched case–control study was facilities in Kombolcha town, ► It was impossible to include clients’ primary data. conducted from April to May 2019. About 130 cases and Northeast, Ethiopia: a case– ► Despite the recommendation of dolutegravir- based 259 controls were selected by simple random sampling. control study. BMJ Open regimen for first- line therapy, its use has not start- Data were extracted from charts of patients using a 2020;10:e036223. doi:10.1136/ ed during the study period and was therefore not bmjopen-2019-036223 structured checklist. Multiple logistic regression analysis considered. was performed to identify possible factors. Hosmer- ► Prepublication history for ► The analysis was not corrected for non-nuc leoside Lemeshow goodness of fit test was used to check this paper is available online. reverse transcriptase inhibitor- based regimen the model. Finally, independent predictor variables of To view these files, please visit independently. the journal online (http:// dx. doi. virological failure were identified based on adjusted OR org/ 10. 1136/ bmjopen- 2019- (AOR) with 95% CI and a p value of 0.05. 036223). Results The odds of virological failure were 2.4- fold http://bmjopen.bmj.com/ (AOR=2.44, 95% CI 1.353 to 4.411) higher in clients as a once- daily dose. However, in Ethiopia Received 18 December 2019 aged <35 years compared with older clients, fivefold the use of DTG-based regimen has not Revised 12 May 2020 (AOR=5.00, 95% CI 2.60 to 9.63) higher in clients who started during this study period. Therefore Accepted 11 June 2020 did not disclose their HIV status, threefold (AOR=2.99, once- daily regimens comprising nucleoside 95% CI 1.33 to 6.73) higher in clients with poor adherence, reverse transcriptase inhibitors backbone and 7.5- fold (AOR=7.51, 95% CI 3.98 to 14.14) higher in (TDF+3TC) and one non-nucleoside reverse 3 clients who had recent CD4 count of ≤250 cells/mm . transcriptase inhibitor (EFV) are being used Conclusion and recommendation This study revealed 3 4 as the preferred choice in adults. To ensure on September 29, 2021 by guest. Protected copyright. that age, marital status, occupation, disclosure status, successful treatment, monitoring of patients baseline functional status, missed clinic visit, current © Author(s) (or their on antiretroviral therapy (ART) should antiretroviral therapy regimen, adherence to treatment 5 6 employer(s)) 2020. Re- use and recent CD4 count were significantly associated with start from the day of initiation. The WHO permitted under CC BY-NC. No immunological criteria for monitoring of commercial re- use. See rights virological failure. Therefore, adherence support should be and permissions. Published by strengthened among clients. Missed clinic visits should response to ART have low sensitivity and posi- BMJ. also be reduced, as it could help clients better adhere tive predictive value in detecting treatment 1Ethiopian Field Epidemiology to treatment, and therefore boost their immunity and failure. Therefore, relying on CD4 counts for Training Program, Bahir Dar suppress viral replication. treatment monitoring would lead to misclas- University, Bahir Dar, Amhara sifications of treatment failure, which could Region, Ethiopia 2 result in unnecessary or delayed switch to Department of Epidemiology BACKGROUND 6 7 and Biostatistics, School of second- line ART. Viral load monitoring is Public Health, College of Medical The prognosis for people with HIV has consid- important to avoid these misclassifications, and Health Sciences, Bahir Dar erably improved since the introduction of the problem of switching to second-line ART University, Bahir Dar, Amhara highly active antiretroviral therapy (HAART) and the risk of drug resistance.7 8 Monitoring region, Ethiopia in 1996.1 2 The preferred first- line regimen for the level of HIV RNA to confirm appropriate Correspondence to adults and adolescents is TDF (Tenofovir Diso- response to treatment and durable viral Mr Zelalem Mehari Nigussie; proxil Fumaratev)+3TC (Lamivudine)+DTG suppression is the most accurate and mean- zelalem2011@ gmail. com (dolutegravir) or TDF+3TC+EFV (Efavirenz) ingful measure of ART effectiveness.9 It is the Meshesha HM, et al. BMJ Open 2020;10:e036223. doi:10.1136/bmjopen-2019-036223 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-036223 on 26 July 2020. Downloaded from gold standard for identification of treatment failure in strategies. Patients who are at risk for virological failure patients on ART, and since 2013 WHO has recommended can be identified early and prevention strategies can be it as the preferred monitoring approach to diagnose and implemented accordingly. In turn patients will get quality confirm antiretroviral (ARV) treatment failure. Viral load service and care, resulting in sustained HIV viral suppres- should be monitored routinely at 6 months, at 12 months sion and contributing to restoring their immune function and every 12 months thereafter.5 6 8 10 Virological failure is with improvements in clinical well-being and reducing defined by a persistently detectable viral load exceeding mortality and HIV transmission at the community level. 1000 copies/mL (ie, two consecutive viral load measure- ments within a 3-month interval, with adherence support between measurements) after at least 6 months of starting a new ART regimen.6 Virological failure can occur for METHODS AND MATERIALS many reasons, such as patient adherence- related factors Study area and period (missed clinic appointments, high pill burden and/or The town of Kombolcha is one of the 21 districts in South dosing frequency) and regimen-related factors (subop- Wollo Zone in Amhara Region. It is 23 km away from the timal pharmacokinetics, reduced efficacy due to prior zonal town of Dessie, 503 km from Bahir Dar and 377 exposure to suboptimal regimens).11 km from Addis Ababa. There are six health posts, four Increasing and monitoring the capacity for viral load government health centres and ten private clinics, with testing are important measures for the global control of two health centres providing ART service. According to HIV, particularly in Sub- Saharan Africa, which has the the information obtained from ART clinics in November highest prevalence of HIV worldwide.12 Studies suggest 2018, about 7178 PLHIV were ever enrolled in ART that around 70% of patients on first-line ART who have a care. Out of these, 5327 ever started ART and 4128 were first high viral load will be virally suppressed following an currently on HAART. The study was conducted from adherence intervention, indicating non-adherence as the April to May 2019. reason for the high viral load in majority of cases.6 The UNAIDS (Joint United Nations Programme on HIV and Study design and population AIDS) targets that 90% of people receiving ART would be An institution- based, unmatched, case–control study was virally suppressed by 2020.13 However, surveys reveal that conducted. The study population consisted of all adults only 32.4% of people living with HIV (PLHIV) have viral living with HIV on first- line ART for 6 months or more suppression.14 Currently, in Ethiopia, 1.5% of patients are before the first viral load test, followed at public health on second- line ART regimens due to first- line treatment facilities in the town of Kombolcha and had their viral failure.15 According to a study in Felegehiwot Referral load tested from October 2016 to October 2018. All Hospital in Amhara Region, since HAART was started, adults living with HIV on first- line ART for 6 months http://bmjopen.bmj.com/ 51.1% of study participants have encountered virological or more before the first viral load test who had docu- failure within 6–48 months.16 The prevalence of virolog- mented viral load test results of >1000 copies/mL with ical failure was 11.5% and 10.7% in studies conducted in two consecutive measurements in a 3-month interval were Tigray and Amhara regions, respectively.16 17 included as cases, whereas those who had documented Previously, targeted virological testing was adopted in viral load test results of ≤1000 copies/mL were included Ethiopia for ART clients who have failed clinically and as controls. Similarly, adults living with HIV on first-line immunologically. However, following WHO recommen- ART for 6 months or more before the first viral load test dation, routine viral load testing has been practised since whose one or both test results were not documented on on September 29, 2021 by guest. Protected copyright. 2016. Currently, a significant number of clients have the high viral load register were excluded from the cases, been experiencing virological failure and have switched whereas test results that were not documented on routine to second- line treatment. Additionally, in 2018, viral viral load register were excluded from the controls. load testing was integrated as one of ten weekly report- able diseases/events in Amhara Public Health Institute. Study variables Despite all these, the reasons for virological failure remain Virological failure was the outcome variable of this study.
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