Effectiveness of Antiretroviral Treatment in a South African ProgramA Cohort Study (original) (raw)
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Effectiveness of Antiretroviral Treatment in a South African Program
2008
The effectiveness of the South African government's expanding antiretroviral treatment program is unknown. Observational studies of treatment effectiveness are prone to selection bias, rarely compare patients receiving antiretroviral treatment with similar patients not receiving antiretroviral treatment, and underestimate mortality rates unless patients are actively followed up.
2008
Introduction The national antiretroviral treatment (ART) programme in South Africa was launched in April 2004. (1) However, for some years prior to this, demonstration projects had provided ART to HIV-infected individuals with advanced disease through government health services. Several projects were located in the Western Cape Province which, as a result, is able to report on outcomes up to 4 years after initiation of therapy. The first such project began providing ART in Khayelitsha in May 2001, (2,3) followed by a project in Gugulethu in September 2002 (4-6) Since inception, the clinical guidelines and approaches to monitoring used in the Western Cape Province have been in line with those recommended by WHO. (7-9) The treatment setting is reflective of public sector health services in South Africa. A description of outcomes 5 years into this provincial programme, and after significant scaling-up of care, has relevance to what can be anticipated in South Africa and other similar s...
The evolution and effectiveness of the South African antiretroviral therapy program
2014
Although South Africa has the largest antiretroviral therapy (ART) program worldwide, data on key outcomes like mortality and loss to follow-up (LTF) are limited. A few cohorts have published patient outcomes but there is no national reporting on ART scale-up and its impact on the health of HIV-infected individuals. Yet such monitoring of outcomes is vital to inform and improve service delivery. The International epidemiologic Databases to Evaluate AIDS Southern Africa collaboration (IeDEA-SA) was established in 2005 to collect and analyze individuallevel data from the larger cohorts of individuals on ART in Southern Africa. Using routine, anonymized data from the South African sites, this thesis aims to describe how the program has evolved over 10 years and to assess its effectiveness. Five quantitative analyses were performed using descriptive statistics and survival analysis methods. The studies used patient-level data on adult patients starting ART to describe characteristics and to explore outcomes and temporal changes in outcomes over time. Patient numbers ranged from 19,481 (limited to cohorts with civil identification numbers) to 83,576 adults, followed for up to 214,400 personyears. The results are presented as four published papers and one submitted for publication. The thesis describes a rapid, massive scale-up of services. Despite improvements in baseline immunologic status, late diagnosis and ART initiation especially in men are a challenge. Over five years, 12-month mortality drops and 12-month LTF increases, suggesting that LTF is a greater challenge to program effectiveness than mortality. Excluding early deaths after TFO/LTF, mortality risk compared with retained patients is similar among TFOs and higher among LTF. Censoring TFOs did not bias mortality estimates due to the lower incidence of TFO and subsequent death compared with LTF. Mortality increases with age at ART initiation, but the effect of age is modified by baseline immunologic status. The proportions of patients ≥50 years old enrolling and remaining in care each year increases. Men have higher mortality on ART than women and this is only partly explained by more advanced HIV disease at ART initiation, differential LTF and subsequent mortality, and differences in responses to treatment. Observed gender differences in mortality on ART may be best explained by background differences in mortality between men and women unrelated to HIV/AIDS or ART. The thesis concludes that the major challenges to program effectiveness are programmatic and not clinical. They include the earlier initiation of patients, especially men and patients ≥50 years old, and the need for good monitoring systems and strategies to retain patients in lifelong chronic care.
Twelve-year mortality in adults initiating antiretroviral therapy in South Africa
Journal of the International AIDS Society
Introduction: South Africa has the largest number of individuals living with HIV and the largest antiretroviral therapy (ART) programme worldwide. In September 2016, ART eligibility was extended to all 7.1 million HIV-positive South Africans. To ensure that further expansion of services does not compromise quality of care, long-term outcomes must be monitored. Few studies have reported long-term mortality in resource-constrained settings, where mortality ascertainment is challenging. Combining site records with data linked to the national vital registration system, sites in the International Epidemiology Databases to Evaluate AIDS Southern Africa collaboration can identify >95% of deaths in patients with civil identification numbers (IDs). This study used linked data to explore long-term mortality and viral suppression among adults starting ART in South Africa. Methods: The study was a cohort analysis of routine data on adults with IDs starting ART 2004-2015 in five large ART cohorts. Mortality was estimated overall and by gender using the Kaplan-Meier estimator and Cox's proportional hazards regression. Standardized mortality ratios (SMRs) were calculated by dividing observed numbers of deaths by numbers expected if patients had been HIV-negative. Viral suppression in patients with viral loads (VLs) in their last year of followup was the secondary outcome. Results: Among 72,812 adults followed for 350,376 person years (pyrs), the crude mortality rate was 3.08 (95% CI 3.02-3.14)/100 pyrs. Patients were predominantly female (67%) and the percentage of men initiating ART did not increase. Cumulative mortality 12 years after ART initiation was 23.9% (33.4% male and 19.4% female). Mortality peaked in patients enrolling in 2007-2009 and was higher in men than women at all durations. Observed mortality rates were higher than HIVnegative mortality, decreasing with duration. By 48 months, observed mortality was close to that in the HIV-negative population, and SMRs were similar for all baseline CD4 strata. Three-quarters of patients had VLs in their last year, and 86% of these were virally suppressed. Conclusions: The South African ART programme has shown a remarkable ability to initiate and manage patients successfully over 12 years, despite rapid expansion. With further scale-up, testing and initiating men on ART must be a national priority.
Antiretroviral therapy and early mortality in South Africa
Bulletin of the World Health Organization, 2008
Objective To describe province-wide outcomes and temporal trends of the Western Cape Province antiretroviral treatment (ART) programme 5 years since inception, and to demonstrate the utility of the WHO monitoring system for ART. Methods The treatment programme started in 2001 through innovator sites. Rapid scaling-up of ART provision began early in 2004, located predominantly in primary-care facilities. Data on patients starting ART were prospectively captured into facility-based registers, from which monthly cross-sectional activity and quarterly cohort reports were aggregated. Retention in care, mortality, loss to follow-up and laboratory outcomes were calculated at 6-monthly durations on ART. Findings By the end of March 2006, 16 234 patients were in care. The cohort analysis included 12 587 adults and 1709 children. Women accounted for 70% of adults enrolled. After 4 and 3 years on ART respectively, 72.0% of adults (95% confidence interval, CI: 68.0-75.6) and 81.5% (95% CI: 75.7-86.1) of children remained in care. The percentage of adults starting ART with CD4 counts less than 50 cells/µl fell from 51.3% in 2001 to 21.5% in 2005, while mortality at 6 months fell from 12.7% to 6.6%, offset in part by an increase in loss to follow-up (reaching 4.7% at 6 months in 2005). Over 85% of adults tested had viral loads below 400 copies/ml at 6-monthly durations until 4 years on ART.
PubMed, 2009
Objectives: To introduce the combined South African cohorts of the International epidemiologic Databases to Evaluate AIDS Southern Africa (IeDEA-SA) collaboration as reflecting the South African national antiretroviral treatment (ART) programme; to characterise patients accessing these services; and to describe changes in services and patients from 2003 to 2007. Design and setting: Multi-cohort study of 11 ART programmes in Gauteng, Western Cape, Free State and KwaZulu-Natal. Subjects: Adults and children (<16 years old) who initiated ART with > or =3 antiretroviral drugs before 2008. Results: Most sites were offering free treatment to adults and children in the public sector, ranging from 264 to 17,835 patients per site. Among 45,383 adults and 6,198 children combined, median age (interquartile range) was 35.0 years (29.8-41.4) and 42.5 months (14.7-82.5), respectively. Of adults, 68% were female. The median CD4 cell count was 102 cells/microl (44-164) and was lower among males than females (86, 34-150 v. 110, 50-169, p<0.001). Median CD4% among children was 12% (7-17.7). Between 2003 and 2007, enrolment increased 11-fold in adults and 3-fold in children. Median CD4 count at enrolment increased for all adults (67-111 cells/microl, p<0.001) and for those in stage IV (39-89 cells/microl, p<0.001). Among children <5 years, baseline CD4% increased over time (11.5-16.0%, p<0.001). Conclusions: IeDEA-SA provides a unique opportunity to report on the national ART programme. The study describes dramatically increased enrolment over time. Late diagnosis and ART initiation, especially of men and children, need attention. Investment in sentinel sites will ensure good individual-level data while freeing most sites to continue with simplified reporting.
Objectives. To introduce the combined South African cohorts of the International epidemiologic Databases to Evaluate AIDS Southern Africa (IeDEA-SA) collaboration as reflecting the South African national antiretroviral treatment (ART) programme; to characterise patients accessing these services; and to describe changes in services and patients from 2003 to 2007. Design and setting. Multi-cohort study of 11 ART programmes in Gauteng, Western Cape, Free State and KwaZulu-Natal. Subjects. Adults and children (<16 years old) who initiated ART with ≥3 antiretroviral drugs before 2008. Results. Most sites were offering free treatment to adults and children in the public sector, ranging from 264 to 17 835 patients per site. Among 45 383 adults and 6 198 children combined, median age (interquartile range) was 35.0 years (29.8 - 41.4) and 42.5 months (14.7 - 82.5), respectively. Of adults, 68% were female. The median CD4 cell count was 102 cells/μl (44 - 164) and was lower among males than females (86, 34 - 150 v. 110, 50 - 169, p<0.001). Median CD4% among children was 12% (7 - 17.7). Between 2003 and 2007, enrolment increased 11-fold in adults and 3-fold in children. Median CD4 count at enrolment increased for all adults (67 - 111 cells/μl, p<0.001) and for those in stage IV (39 - 89 cells/μl, p<0.001). Among children <5 years, baseline CD4% increased over time (11.5 - 16.0%, p<0.001). Conclusions. IeDEA-SA provides a unique opportunity to report on the national ART programme. The study describes dramatically increased enrolment over time. Late diagnosis and ART initiation, especially of men and children, need attention. Investment in sentinel sites will ensure good individual-level data while freeing most sites to continue with simplified reporting.