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      HIV Drug Resistance Early Warning Indicators in Namibia with Updated World Health Organization Guidance

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          Abstract

          Background

          In response to concerns about the emergence of HIV drug resistance (HIVDR), the World Health Organization (WHO) has developed a comprehensive set of early warning indicators (EWIs) to monitor HIV drug resistance and good programme practice at antiretroviral therapy (ART) sites.

          Methods

          In 2012, Namibia utilized the updated WHO EWI guidance and abstracted data from adult and pediatric patients from 50 ART sites for the following EWIs: 1. On-time Pill Pick-up, 2. Retention in Care, 3. Pharmacy Stock-outs, 4. Dispensing Practices, and 5. Virological Suppression.

          Results

          Data for EWIs one through four were abstracted and validated. EWI 5 – Virological Suppression was not included due to poor data entry at many sites. On-time Pill Pick-up national estimate was 87.9% (87.2–88.7) of patients picking up pills on time for adults and 90.0% (88.9–90.9) picking up pills on time for pediatrics. Retention in Care national estimate was 82% of patients retained on ART after 12 months for adults and 83% for pediatrics. Pharmacy Stock-outs national estimate was 99% of months without a stock-out for adults and 97% for pediatrics. Dispensing Practices national estimate was 0.01% (0.003–0.064) of patients dispensed mono- or dual-therapy for adults and 0.25% (0.092–0.653) for pediatrics.

          Conclusions

          The successful 2012 EWI exercise provides Namibia a solid evidence base, which can be used to make national statements about programmatic functioning and possible HIVDR. This evidence base will serve to contextualize results from Namibia's surveys of HIVDR, which involves genotype testing. EWI abstraction has prompted the national program and its counterparts to engage sites in dialogue regarding the need to strengthen adherence and retention of patients on ART. The EWI collection process and EWI results will serve to optimize patient care and support Namibia in making evidence-based recommendations and take action to minimize the emergence of preventable HIVDR.

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          HIV population dynamics in vivo: implications for genetic variation, pathogenesis, and therapy.

          J M Coffin (1995)
          Several recent reports indicate that the long, clinically latent phase that characterizes human immunodeficiency virus (HIV) infection of humans is not a period of viral inactivity, but an active process in which cells are being infected and dying at a high rate and in large numbers. These results lead to a simple steady-state model in which infection, cell death, and cell replacement are in balance, and imply that the unique feature of HIV is the extraordinarily large number of replication cycles that occur during infection of a single individual. This turnover drives both the pathogenic process and (even more than mutation rate) the development of genetic variation. This variation includes the inevitable and, in principle, predictable accumulation of mutations such as those conferring resistance to antiviral drugs whose presence before therapy must be considered in the design of therapeutic strategies.
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            Mortality of Patients Lost to Follow-Up in Antiretroviral Treatment Programmes in Resource-Limited Settings: Systematic Review and Meta-Analysis

            Martin Brinkhof, Mar Pujades-Rodríguez, Matthias Egger (2009)
            Background The retention of patients in antiretroviral therapy (ART) programmes is an important issue in resource-limited settings. Loss to follow up can be substantial, but it is unclear what the outcomes are in patients who are lost to programmes. Methods and Findings We searched the PubMed, EMBASE, Latin American and Caribbean Health Sciences Literature (LILACS), Indian Medlars Centre (IndMed) and African Index Medicus (AIM) databases and the abstracts of three conferences for studies that traced patients lost to follow up to ascertain their vital status. Main outcomes were the proportion of patients traced, the proportion found to be alive and the proportion that had died. Where available, we also examined the reasons why some patients could not be traced, why patients found to be alive did not return to the clinic, and the causes of death. We combined mortality data from several studies using random-effects meta-analysis. Seventeen studies were eligible. All were from sub-Saharan Africa, except one study from India, and none were conducted in children. A total of 6420 patients (range 44 to 1343 patients) were included. Patients were traced using telephone calls, home visits and through social networks. Overall the vital status of 4021 patients could be ascertained (63%, range across studies: 45% to 86%); 1602 patients had died. The combined mortality was 40% (95% confidence interval 33%–48%), with substantial heterogeneity between studies (P<0.0001). Mortality in African programmes ranged from 12% to 87% of patients lost to follow-up. Mortality was inversely associated with the rate of loss to follow up in the programme: it declined from around 60% to 20% as the percentage of patients lost to the programme increased from 5% to 50%. Among patients not found, telephone numbers and addresses were frequently incorrect or missing. Common reasons for not returning to the clinic were transfer to another programme, financial problems and improving or deteriorating health. Causes of death were available for 47 deaths: 29 (62%) died of an AIDS defining illness. Conclusions In ART programmes in resource-limited settings a substantial minority of adults lost to follow up cannot be traced, and among those traced 20% to 60% had died. Our findings have implications both for patient care and the monitoring and evaluation of programmes.
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              Association between adherence to antiretroviral therapy and human immunodeficiency virus drug resistance.

              Robert Moore, Sidharth Sethi, Ailie J E Gallant … (2003)
              Nonadherence to highly active antiretroviral therapy (HAART) is a major cause of human immunodeficiency virus (HIV) drug resistance; however the level of nonadherence associated with the greatest risk of resistance is unknown. Beginning in February 2000, 195 patients at the Johns Hopkins Outpatient Center (Baltimore, MD) who were receiving HAART and who had HIV loads of <500 copies/mL were recruited into a cohort study and observed for 1 year. At each visit, adherence to HAART was assessed and plasma samples were obtained and stored for resistance testing, if indicated. The overall incidence of viral rebound with clinically significant resistance was 14.5 cases per 100 person-years. By multivariate Cox proportional hazards regression, a cumulative adherence of 70%-89%, a CD4 cell nadir of <200 cells/microL, and the missing of a scheduled clinic visit in the past month were independently associated with an increased hazard of viral rebound with clinically significant resistance. Clinicians and patients must set high adherence goals to avoid the development of resistance.
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                Author and article information

                Contributors
                Omar Sued: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS ONE
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosone
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, USA )
                ISSN (Electronic): 1932-6203
                Publication date Collection: 2014
                Publication date (Electronic): 2 July 2014
                Volume: 9
                Issue: 7
                Electronic Location Identifier: e100539
                Affiliations
                [1 ]Directorate of Special Programmes, Republic of Namibia Ministry of Health and Social Services, Windhoek, Namibia
                [2 ]Strengthening Pharmaceutical Systems, Management Sciences for Health, Windhoek, Namibia
                [3 ]Department of Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts, United States of America
                [4 ]Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Boston, Massachusetts, United States of America
                [5 ]World Health Organization Namibia, Klein Windhoek, Namibia
                Fundacion Huesped, Argentina
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: AJ VS MRJ TD SYH. Performed the experiments: VS SM MD SP SYH. Analyzed the data: AJ VS FT SP MRJ TD AMT SYH. Wrote the paper: AJ VS SP MRJ AMT SYH.

                Article
                Publisher ID: PONE-D-14-11010
                DOI: 10.1371/journal.pone.0100539
                PMC ID: 4079656
                PubMed ID: 24988387
                SO-VID: bfade786-e83d-49ca-a125-37891d1da1c2
                Copyright statement: Copyright @ 2014
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 11 March 2014
                Date accepted : 25 May 2014
                Page count
                Pages: 9
                Funding
                This work was supported by funding from the Republic of Namibia Ministry of Health and Social Services, National Institutes of Health, NIH L30 AI080268-02 (SYH), NIH 1K23AI097010-01A1 (SYH), NIH K23 AI074423-05 (MRJ), and NIH P30 AI42853-10 (AMT). Travel expenses for this study were supported in part by the Harold Williams Tufts Medical Student Research Fellowship (SP). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
                Subject: Research Article
                Subject: Medicine and health sciences
                Subject: Epidemiology
                Subject: HIV epidemiology
                Subject: Infectious Diseases
                Subject: Viral Diseases
                Subject: AIDS
                Subject: People and Places
                Subject: Geographical Locations
                Subject: Africa
                Subject: Namibia
                Subject: Social Sciences
                Subject: Sociology
                Subject: Social Research
                Custom metadata
                Data Availability The authors confirm that all data underlying the findings are fully available without restriction. Please email corresponding author: shong@ 123456tuftsmedicalcenter.org .

                ScienceOpen disciplines: Uncategorized
                Data availability:
                ScienceOpen disciplines: Uncategorized

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