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      Determinants of immunological recovery following HAART among severely immunosuppressed patients at enrolment to care in Northern Ethiopia: a retrospective study

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          Abstract

          Objective

          This study aimed to identify determinants of immunological recovery following highly active antiretroviral therapy (HAART) among severely immunosuppressed patients at enrolment to care in Northern Ethiopia.

          Methods

          A retrospective study.

          Setting

          The study was done in Tigray Region, Northern Ethiopia.

          Participants

          The study was done among severely immunosuppressed (<200 CD4 cells/mm 3) individuals at initial enrolment to care and whose samples were sent for viral load determination from April 2015 to March 2019 in Tigray Health Research Institute.

          Main outcomes

          The main outcome variable was immunological recovery, modelled using binary logistic regression.

          Results

          Among the 9687 patients with severe immunosuppression at enrolment, 2746 (28.35%, 95% CI 27.45% to 29.26%) had immunological recovery following HAART for at least 6 months. Male gender (adjusted OR (AOR)=0.50, p<0.001), age 20–34 years old (AOR=0.33, p<0.001), age ≥50 years old (AOR=0.26, p<0.001), WHO clinical stage III (OR=0.68, p=0.036) and viral non-suppression (AOR=0.38, p<0.001) were strong predictors of immunological failure.

          Conclusions

          Immunological recovery following HAART was low among severely immunosuppressed individuals at enrolment to care. Gender, age, WHO stage III and viral non-suppression were determinants of immunological recovery. Male patients, adolescents and virally non-suppressed patients should be identified as groups at higher risk for immunological failure. Therefore, greater support and intensive counselling should be prioritised among adolescents, men and virally non-suppressed patients for better immunological recovery.

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          Most cited references38

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          Positive effects of combined antiretroviral therapy on CD4+ T cell homeostasis and function in advanced HIV disease.

          B Autran, G Carcelain, T. S. Li … (1997)
          Highly active antiretroviral therapy (HAART) increases CD4(+) cell numbers, but its ability to correct the human immunodeficiency virus (HIV)-induced immune deficiency remains unknown. A three-phase T cell reconstitution was demonstrated after HAART, with: (i) an early rise of memory CD4(+) cells, (ii) a reduction in T cell activation correlated to the decreasing retroviral activity together with an improved CD4(+) T cell reactivity to recall antigens, and (iii) a late rise of "naïve" CD4(+) lymphocytes while CD8(+) T cells declined, however, without complete normalization of these parameters. Thus, decreasing the HIV load can reverse HIV-driven activation and CD4(+) T cell defects in advanced HIV-infected patients.
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            Incomplete peripheral CD4+ cell count restoration in HIV-infected patients receiving long-term antiretroviral treatment.

            Colleen Kelley, Christina Kitchen, Peter W. Hunt … (2009)
            Although antiretroviral therapy has the ability to fully restore a normal CD4(+) cell count (>500 cells/mm(3)) in most patients, it is not yet clear whether all patients can achieve normalization of their CD4(+) cell count, in part because no study has followed up patients for >7 years. Three hundred sixty-six patients from 5 clinical cohorts who maintained a plasma human immunodeficiency virus (HIV) RNA level 1000 copies/mL for at least 4 years after initiation of antiretroviral therapy were included. Changes in CD4(+) cell count were evaluated using mixed-effects modeling, spline-smoothing regression, and Kaplan-Meier techniques. The majority (83%) of the patients were men. The median CD4(+) cell count at the time of therapy initiation was 201 cells/mm(3) (interquartile range, 72-344 cells/mm(3)), and the median age was 47 years. The median follow-up period was 7.5 years (interquartile range, 5.5-9.7 years). CD4(+) cell counts continued to increase throughout the follow-up period, albeit slowly after year 4. Although almost all patients (95%) who started therapy with a CD4(+) cell count 300 cells/mm(3) were able to attain a CD4(+) cell count 500 cells/mm(3), 44% of patients who started therapy with a CD4(+) cell count 500 cells/mm(3) over a mean duration of follow-up of 7.5 years; many did not reach this threshold by year 10. Twenty-four percent of individuals with a CD4(+) cell count <500 cells/mm(3) at year 4 had evidence of a CD4(+) cell count plateau after year 4. The frequency of detectable viremia ("blips") after year 4 was not associated with the magnitude of the CD4(+) cell count change. A substantial proportion of patients who delay therapy until their CD4(+) cell count decreases to <200 cells/mm(3) do not achieve a normal CD4(+) cell count, even after a decade of otherwise effective antiretroviral therapy. Although the majority of patients have evidence of slow increases in their CD4(+) cell count over time, many do not. These individuals may have an elevated risk of non-AIDS-related morbidity and mortality.
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              CD4+ cell count 6 years after commencement of highly active antiretroviral therapy in persons with sustained virologic suppression.

              Robert Moore, Jeanne Keruly (2007)
              Sustained suppression of the human immunodeficiency virus (HIV) type 1 RNA load with the use of highly active antiretroviral therapy (HAART) results in immunologic improvement, but it is not clear whether the CD4(+) cell count increases to normal levels or whether it reaches a less-than-normal plateau. We characterized the increase in the CD4(+) cell count in patients in clinical practice who maintained sustained viral suppression for up to 6 years. All patients were from the Johns Hopkins HIV Clinical Cohort, a longitudinal observational study of patients receiving primary HIV care in Baltimore, Maryland, who were observed for >1 year while receiving HAART and who had sustained suppression of the HIV RNA load at 350 cells/microL, and we assessed the development of clinical events (death and new acquired immunodeficiency syndrome-defining illness) by Kaplan-Meier analysis. A total of 655 patients were observed for a median of 46 months (range, 13-72 months). The median change from baseline to most recent CD4(+) cell count was +274 cells/microL, with 92% of patients having an increase in CD4(+) cell count. By 6 years, the median CD4(+) cell count was 493 cells/microL among patients with baseline CD4(+) cell counts 350 cells/microL. In addition to baseline CD4(+) cell count, injection drug use and older age were associated with a lesser CD4(+) cell count response, and duration of therapy was associated with a greater CD4(+) cell count response. Only patients with baseline CD4(+) cell counts >350 cells/microL returned to nearly normal CD4(+) cell counts after 6 years of follow-up. Significant increases were observed in all CD4(+) cell count strata during the first year, but there was a lower plateau CD4(+) cell count at lower baseline CD4(+) cell strata. These data suggest that waiting to start HAART at lower CD4(+) cell counts will result in the CD4(+) cell count not returning to normal levels.
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                Author and article information

                Journal
                Journal ID (nlm-ta): BMJ Open
                Journal ID (iso-abbrev): BMJ Open
                Journal ID (hwp): bmjopen
                Journal ID (publisher-id): bmjopen
                Title: BMJ Open
                Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                ISSN (Electronic): 2044-6055
                Publication date Collection: 2020
                Publication date (Electronic): 31 August 2020
                Volume: 10
                Issue: 8
                Electronic Location Identifier: e038741
                Affiliations
                [1 ]departmentPublic Health Research , Tigray Health Research Institute , Mekelle, Tigray, Ethiopia
                [2 ]Tigray Health Research Institute , Mekelle, Tigray, Ethiopia
                [3 ]departmentMicrobiology , Mekelle University College of Health Sciences , Mekelle, Tigray, Ethiopia
                [4 ]departmentBiostatistics School of Public Health , Mekelle University College of Health Sciences , Mekelle, Tigray, Ethiopia
                Author notes
                [Correspondence to ] Abraham Aregay Desta; abaregaydesta@ 123456gmail.com
                Author information
                http://orcid.org/0000-0002-1505-7451
                http://orcid.org/0000-0001-7619-1112
                Article
                Publisher ID: bmjopen-2020-038741
                DOI: 10.1136/bmjopen-2020-038741
                PMC ID: 7462238
                PubMed ID: 32868365
                SO-VID: ed1d6a73-1398-416c-a9d3-e83e59a506e3
                Copyright © © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
                License:

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                Date received : 26 March 2020
                Date revision received : 10 June 2020
                Date accepted : 02 July 2020
                Categories
                Subject: Immunology (Including Allergy)
                Subject: 1506
                Subject: 1705
                Series title: Original research
                Custom metadata
                special-feature unlocked

                ScienceOpen disciplines: Medicine
                Keywords: immunology,hiv & aids,epidemiology
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: immunology, hiv & aids, epidemiology

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