Abstract
Rates of first-line treatment failure and switches to second-line therapy are key indicators for national HIV programmes. We assessed immunological treatment failure defined by WHO criteria in the Tanzanian national HIV programme. We included adults initiating first-line therapy in 2004-2011 with a pre-treatment CD4 count, and ≥6-months of follow-up. We assessed subhazard ratios (SHR) for immunological treatment failure, and subsequent switch to second-line therapy, using competing risks methods to account for deaths. Of 121308 adults, 7% experienced immunological treatment failure, and 2% died without observed immunological treatment failure, over a median 1.7years. The 6-year cumulative probability of immunological treatment failure was 19.0% (95% CI 18.5, 19.7) and of death, 5.1% (4.8, 5.4). Immunological treatment failure predictors included earlier year of treatment initiation (P<0.001), initiation in lower level facilities (SHR=2.23 [2.03, 2.45] for dispensaries vs. hospitals), being male (1.27 [1.19, 1.33]) and initiation at low or high CD4 counts (for example, 1.78 [1.65, 1.92] and 5.33 [4.65, 6.10] for <50 and ≥500 vs. 200-349 cells/mm(3) , respectively). Of 7382 participants in the time-to-switch analysis, 6% switched and 5% died before switching. Four years after immunological treatment failure, the cumulative probability of switching was 7.3% (6.6, 8.0) and of death, 6.8% (6.0, 7.6). Those who immunologically failed in dispensaries, health centres and government facilities were least likely to switch. Immunological treatment failure rates and unmet need for second-line therapy are high in Tanzania; virological monitoring, at least for persons with immunological treatment failure, is required to minimise unnecessary switches to second-line therapy. Lower level government health facilities need more support to reduce treatment failure rates and improve second-line therapy uptake to sustain the benefits of increased coverage.
Highlights
The year 2012 saw the largest annual increase of HIV-positive persons receiving antiretroviral therapy (ART), with 9.7 million people in low- and middle-income countries on ART [1]
In the Results section, we already indicate why patients are removed from the analysis, and we have added text to the Discussion to discuss the key issue of missing baseline CD4 counts: “Due to the definition of immunological treatment failure (ITF), we were not able to include nearly a third of registered participants since they did not have a baseline CD4 count; it is difficult to know whether this selection has led to bias in our results.”
The six-year cumulative probability of ITF was 19.0% and death 5.1% (4.8,5.4)
Summary
The year 2012 saw the largest annual increase of HIV-positive persons receiving antiretroviral therapy (ART), with 9.7 million people in low- and middle-income countries on ART [1]. In 21 African countries with the highest HIV burden, two-thirds of people in need of treatment in 2012 were receiving ART [1]. Monitoring persons on ART for treatment failure is essential to ensure that their treatment remains potent and to enable timely switches from first- to second-line therapy. The World Health Organization (WHO) recommends routine viral load monitoring for persons on ART [2], but this remains too expensive for resource-limited countries such as Tanzania. In the absence of viral-load monitoring, treatment failure is diagnosed using immunological and clinical criteria [2], as implemented in Tanzanian policy [10,11,12]. There is a paucity of data on the rates and predictors of first-line treatment failure, and the use of second-line therapy, within national programs using immunological and/or clinical criteria
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