Switching HIV Treatment in Adults Based on CD4 Count Versus Viral Load Monitoring: A Randomized, Non-Inferiority Trial in Thailand

Jourdain, Gonzague; Cœur, Sophie Le; Ngo‐Giang‐Huong, Nicole; Traisathit, Patrinee; Cressey, Tim R.; Fregonese, Federica; Leurent, Baptiste; Collins, Intira Jeannie; Techapornroong, Malee; Banchongkit, Sukit; Buranabanjasatean, Sudanee; Halue, Guttiga; Nilmanat, Ampaipith; Luekamlung, Nuananong; Klinbuayaem, Virat; Chutanunta, Apichat; Kantipong, Pacharee; Bowonwatanuwong, Chureeratana; Lertkoonalak, Rittha; Leenasirimakul, Prattana; Tansuphasawasdikul, Somboon; Sang-A-Gad, Pensiriwan; Pathipvanich, Panita; Srisuda, Thongbuaban; Wittayapraparat, Pakorn; Naree, Eiamsirikit; Yuwadee, Buranawanitchakorn; Yutthakasemsunt, Naruepon; Winiyakul, Narong; Decker, Luc; Barbier, Sylvaine; Koetsawang, Suporn; Sirirungsi, Wasna; McIntosh, Kenneth; Thanprasertsuk, Sombat; Lallemant, Marc; team, Phpt study

doi:10.1371/journal.pmed.1001494

Cited by 36 publications

(38 citation statements)

References 30 publications

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“…Our findings are consistent with current guidelines not only from WHO [51] but also from the United States Department of Health and Human Services [52] and the British HIV Association [53], which recommend the use of plasma viral load monitoring to detect virologic failure and to guide changes in ART. However, we also note that there is a substantial randomized controlled trial literature that suggests immunologic or clinical and immunologic monitoring is not inferior to virologic monitoring when measured against clinical endpoints [8][9][10][11].…”

Section: Discussionmentioning

confidence: 99%

“…Five randomized controlled trials have assessed whether different monitoring strategies (laboratory vs. clinical) are associated with biological outcomes such as death and disease progression as well as unnecessary changes to second-line therapy [7][8][9][10][11]. Two studies, conducted in Uganda and Zimbabwe [7,8] found that clinical monitoring was inferior to laboratory monitoring.…”

Section: Introductionmentioning

confidence: 99%

“…Another study in Thailand found no difference in 3-year clinical outcomes using immunologic monitoring compared to viral load monitoring [9]. A study in Cameroon compared clinical monitoring alone to immunologic and virologic monitoring and found small benefits in immunologic recovery in participants who received laboratory monitoring, but not for other endpoints [10].…”

Section: Introductionmentioning

confidence: 99%

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Predicting treatment failure in adults and children on antiretroviral therapy

Rutherford

Anglemyer

Easterbrook

et al. 2014

AIDS

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Predicting treatment failure in adults and children on antiretroviral therapy

Rutherford

Anglemyer

Easterbrook

et al. 2014

AIDS

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“…In adults several modelling studies [6–8] and two randomised controlled trials [9–11] showed that routine VL monitoring may reduce mortality slightly, and substantially increase costs. These results cannot be generalised to children: progression of HIV is faster in children than in adults, the CD4 cell count declines with age, and ART regimens differ [1, 12–14].…”

Section: Introductionmentioning

confidence: 99%

Viral load versus CD4+ monitoring and 5-year outcomes of antiretroviral therapy in HIV-positive children in Southern Africa

Salazar‐Vizcaya¹,

Keiser²,

Technau³

et al. 2014

Aids

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Objectives Many paediatric antiretroviral therapy (ART) programmes in Southern Africa rely on CD4 counts to monitor ART. We assessed the benefit of replacing CD4 by viral load (VL) monitoring. Design Mathematical modelling study. Methods Simulation model of HIV progression over 5 years in children on ART, parameterised by data from seven South African cohorts. We simulated treatment programmes with 6-monthly CD4 count or 6- or 12-monthly VL monitoring. We compared mortality, second-line ART use, immunological failure and time spent on failing ART. In further analyses we varied the rate of virological failure, and assumed that the rate is higher with CD4 than with VL monitoring. Results About 7% of children were predicted to die within 5 years, independent of the monitoring strategy. Compared with CD4 monitoring, 12-monthly VL monitoring reduced the 5-year risk of immunological failure from 1.6% to 1.0% and the mean time spent on failing ART from 6.6 to 3.6 months; 1% of children with CD4 compared to 12% with VL monitoring switched to second-line ART. Differences became larger when assuming higher rates of virological failure. When assuming higher virological failure rates with CD4 than with VL monitoring, up to 4.2% of children with CD4 compared to 1.5% with VL monitoring experienced immunological failure; the mean time spent on failing ART was 27.3 months with CD4 monitoring and 6.0 months with VL monitoring. Conclusions VL monitoring did not affect 5-year mortality, but reduced time on failing ART, improved immunological response and increased switching to second-line ART.

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“…[22] In a recent randomized trial conducted in Thailand among 713 ART naïve patients, showed that using CD4 counts alone to monitor highly active ART in HIV treatment programs in resource-limited settings is an appropriate strategy to use as viral load measurement becomes more affordable and feasible in these settings. [23] Monitoring of the HIV viral measurement is central to therapeutic HIV management worldwide and recommended in the WHO 2013 consolidated guidelines. [24,25] However, in low-and middle-income countries, with limited resources and restricted access to costly second-and third-line drugs, the utility of this approach continues to be debated.…”

Section: Discussionmentioning

confidence: 99%

"Know your CD4 campaign": 6-year outcomes from a quality improvement initiative to promote earlier initiation of antiretroviral therapy in Tanzania

Memiah¹,

Shumba²,

Henley³

et al. 2014

Int J Med Public Health

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Background: Late initiation of treatment for illness secondary to the human immunodefi ciency virus (HIV) remains a major challenge in developing countries. Despite the World Health Organization (WHO) recommendation that treatment be initiated early in disease management, health providers conducting quality improvement monitoring in one region of Tanzania noted that common management practice relies upon clinical signs of advanced disease alone for initiation of combination antiretroviral therapy (ART). Although Tanzanian National Treatment Guidelines followed standard WHO recommendations, few patients initiated ART based on laboratory parameters. As a potential barrier to optimal patient outcomes, further investigation of this inconsistency led to recognition of challenges refl ecting patient, healthcare staff, and laboratory levels that might inhibit the use of CD4 cell counts as the entryway to care. Materials and Methods: Using a quality improvement approach, investigations were pursued for six discrete activities of HIV care delivery with before and after measures of selected indicators. With respect to patient engagement, meetings and informal educational sessions were held to promote understanding of the meaning of and need for CD4 testing. For clinic staff: (1) Qualitative interviews were conducted with providers to understand why laboratory data was not being used and (2) on-site interviews were conducted with laboratory personnel to review beliefs, methods, and practices related to measurement of CD4 cells testing. A large scale local campaign was mounted to (1) educate and empower patients to recognize a need for CD4 information in management of their own care; (2) re-educate and encourage providers to use measured, rather than clinical observation alone to initiate ART; and (3) understand and resolve clinical and laboratory challenges. Based upon fi ndings from the interviews: (1) Meetings with hospital administrations were effected to resolve institutional barriers to using CD4 cell testing. Specifi c on-site training was initiated for both providers, with regard to use of CD4 cell counts, and nurses, with advanced training to initiate routine CD4 testing. These activities were well received because all staff were able to review unlinked, site-based clinical data to appreciate gaps in a local care. Results: The number of CD4 samples obtained and recorded increased by 114% between May and October 2007 at targeted health facilities. ART enrollment increased by 62% between June and September 2007 without other signifi cant change in care delivery. The median baseline CD4 at enrollment increased from 110 cells/mm 3 in June to 150 cells/mm 3 in September. Overall retention rate was 77% for 13,333 HIV patients enrolled in seven facilities. In September 2013, the cumulative 6-year overall retention rates are 77% for 53,040 patients enrolled in 42 health facilities in the region. Obstacles were addressed and community empowerment techniques used to stimulate change in established clinical behaviors. Conclusi...

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Switching HIV Treatment in Adults Based on CD4 Count Versus Viral Load Monitoring: A Randomized, Non-Inferiority Trial in Thailand

Cited by 36 publications

References 30 publications

Predicting treatment failure in adults and children on antiretroviral therapy

Predicting treatment failure in adults and children on antiretroviral therapy

Viral load versus CD4+ monitoring and 5-year outcomes of antiretroviral therapy in HIV-positive children in Southern Africa

"Know your CD4 campaign": 6-year outcomes from a quality improvement initiative to promote earlier initiation of antiretroviral therapy in Tanzania

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