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Monitoring of HIV Viral Load, CD4 Cell Count, and Clinical Assessment

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Monitoring of HIV Viral Load, CD4 Cell Count, and Clinical Assessment Articles Monitoring of HIV viral load, CD4 cell count, and clinical assessment versus clinical monitoring alone for antiretroviral therapy in low-resource settings (Stratall ANRS 12110/ESTHER): a cost-eff ectiveness analysis Sylvie Boyer, Laura March, Charles Kouanfack, Gabrièle Laborde-Balen, Patricia Marino, Avelin Fobang Aghokeng, Eitel Mpoudi-Ngole, Sinata Koulla-Shiro, Eric Delaporte, Maria Patrizia Carrieri, Bruno Spire, Christian Laurent, Jean-Paul Moatti, on behalf of the Stratall ANRS 12110/ESTHER Study Group* Summary Background In low-income countries, the use of laboratory monitoring of patients taking antiretroviral therapy Lancet Infect Dis 2013; (ART) remains controversial in view of persistent resource constraints. The Stratall trial did not show that clinical 13: 577–86 monitoring alone was non-inferior to laboratory and clinical monitoring in terms of immunological recovery. We Published Online aimed to evaluate the costs and cost-eff ectiveness of the ART monitoring approaches assessed in the Stratall trial. April 18, 2013 http://dx.doi.org/10.1016/ S1473-3099(13)70073-2 Methods The randomised, controlled, non-inferiority Stratall trial was done in a decentralised setting in Cameroon. See Comment page 560 Between May 23, 2006, and Jan 31, 2008, ART-naive adults were randomly assigned (1:1) to clinical monitoring *Members listed at end of paper (CLIN) or viral load and CD4 cell count plus clinical monitoring (LAB) and followed up for 24 months. We INSERM, UMR912 (SESSTIM), calculated costs, number of life-years saved (LYS), and incremental cost-eff ectiveness ratios (ICERs) with data Marseille, France (S Boyer PhD, from patients who had been followed up for at least 6 months. We considered two cost scenarios in which viral L March MSc, P Marino PhD, load plus CD4 cell count tests cost either US$95 (scenario 1; Abbott RealTime HIV-1 assay) or $63 (scenario 2; M P Carrieri PhD, B Spire MD, generic assay). We compared ICERs with a WHO-recommended threshold of three times the per-person gross Prof J-P Moatti PhD); Aix Marseille Université, domestic product (GDP) for Cameroon ($3670–3800) and an alternative lower threshold of $2385 to UMR-S912, IRD, Marseille, determine cost-eff ectiveness. We assessed uncertainty with one-way sensitivity analyses and cost-eff ectiveness France (S Boyer, L March, acceptability curves. P Marino, M P Carrieri, B Spire, J-P Moatti); Observatoire Régional de la Santé Provence– Findings 188 participants who underwent LAB and 197 who underwent CLIN were followed up for at least 6 months. Alpes–Côte d’Azur (ORS PACA), In scenario 1, LAB increased costs by a mean of $489 (SD 430) per patient and saved 0·103 life-years compared with Marseille, France (S Boyer, CLIN (ICER of $4768 [95% CI 3926–5613] per LYS). In scenario 2, the incremental mean cost of LAB was L March, M P Carrieri, B Spire, $343 (SD 425)—ie, an ICER of $3339 (2507–4173) per LYS. A combined strategy in which LAB would only be used in J-P Moatti); Central Hospital, UMI 233, Yaoundé, Cameroon patients starting ART with a CD4 count of 200 cells per μL or fewer suggests that 0·120 life-years would be saved at (C Kouanfack MD, an additional cost of $259 per patient in scenario 1 (ICER of $2167 [95% CI 1314–3020] per LYS) and $181 in scenario Prof S Koulla-Shiro MD); French 2 (ICER of $1510 [692–2329] per LYS) when compared with CLIN. Ministry of Foreign Aff airs, Yaoundé, Cameroon (G Laborde-Balen MSc); Institut Interpretation Laboratory monitoring was not cost eff ective in 2006–10 compared with clinical monitoring when the de Recherche pour le Abbott RealTime HIV-1 assay was used according to the $3670 cost-eff ectiveness threshold (three times per-person Développement (IRD), GDP in Cameroon), but it might be cost eff ective if a generic in-house assay is used. University Montpellier 1, UMI 233, Montpellier, France (A Fobang Aghokeng PhD, Funding French National Agency for Research on AIDS and Viral Hepatitis (ANRS) and Ensemble pour une Solidarité Prof E Delaporte MD, Thérapeutique Hospitalière En Réseau (ESTHER). C Laurent PhD); Virology Laboratory IRD/IMPM/ 3 CREMER, Yaoundé, Cameroon Introduction second-line regimens, virological monitoring is still very (A Fobang Aghokeng, 4 Although access to antiretroviral therapy (ART) is still not rare in low-income and middle-income countries. E Mpoudi-Ngole MD); Faculté de universal in low-income and middle-income coun tries, In the coming years, a large proportion of patients Médecine et des Sciences large increases in donor funding in the past 10 years have receiving ART are expected to have therapeutic failure, Biomédicales, University of Yaoundé 1, Yaoundé, led to substantial progress, with about 8 million people in leading to a higher risk of not only HIV-related morbidity Cameroon (S Koulla-Shiro); and these countries receiving ART at the end of 2011.1 and mortality but also HIV transmission from drug- Department of Infectious and Widespread and rapid scale-up of ART has also been resistant strains. Evidence has shown that viral load Tropical Diseases, University supported by a public health approach that promotes the monitoring identifi es patients with ART failure more Hospital, Montpellier, France (E Delaporte) initiation and monitoring of ART based on clinical criteria accurately than does clinical or immuno logical moni- 2 5–7 Correspondence to: and, when available, on CD4 cell count. Although the toring, and does so earlier, which in turn leads to Dr Sylvie Boyer, INSERM, U912 2010 revised WHO guidelines now recom mend the use of earlier use of second-line therapies (if available), a (SESSTIM), 13006 Marseille, HIV viral load, if available, to detect or confi rm treatment shorter duration spent with virological failure, and France failure and to inform decisions about switching to decreased drug resistance.6,8,9 [email protected] www.thelancet.com/infection Vol 13 July 2013 577 Articles Accordingly, the use of laboratory monitoring, in- in terms of im munological recovery was not shown. cluding viral load measurement, to optimise treatment Furthermore, 13 (6%) of 221 participants who were outcomes is becoming increasingly topical.10,11 Ran- assigned to both laboratory and clinical monitoring domised trials have shown that routine monitoring of switched to second-line regimens, whereas nobody in the CD4 cell count, with or without viral load measurement, clinical monitoring alone group did (p<0·0001). Other provides tangible clinical benefi ts in terms of mortality, predefi ned sec ondary outcomes, including viral disease progression, and immune recovery compared suppression, mortality, disease progression, HIV with clinical monitoring alone.12–14 In the Stratall trial12— resistance, and adherence, were very similar in both which assessed ART monitoring strategies at the district groups. level in Cameroon—non-inferiority of clinical monitoring Because available resources for HIV programme alone compared with laboratory and clinical monitoring funding are decreasing, one question that needs to be addressed is whether the benefi ts from laboratory monitoring are large enough to justify the associated LAB (n=188) CLIN (n=197) extra costs. With the exception of one study,15 investi- Sex gations assessing the cost-eff ectiveness of laboratory Women 135 (71·8%) 142 (72·1%) monitoring, including viral load, in low-income coun- Men 53 (28·2%) 55 (27·9%) tries have been based on mathematical models16–21 and Age (years) 37·5 (31·0–45·1) 35·9 (30·0–44·8) shown contradictory results.22,23 Additionally, until now, Marital status* no cost-eff ectiveness study had been done in the context Married or cohabiting 53 (29·0%) 68 (35·1%) of decentralised ART delivery with local non-specialist Divorced or separated 7 (3·8%) 4 (2·1%) health workers, a setting that represents the reality of Widowed 25 (13·7%) 25 (12·9%) health care in low-income settings. We therefore aimed Single 98 (53·6%) 97 (50·0%) to evaluate the cost and cost-eff ectiveness of the Level of education* laboratory and clinical monitoring approach versus the No formal education 4 (2·2%) 5 (2·6%) clinical approach alone assessed in the Stratall trial. Primary school 82 (44·8%) 93 (47·9%) Secondary school or higher 97 (53·0%) 96 (49·5%) Methods Head of the household† Stratall trial design, participants, and procedures No 82 (45·8%) 93 (49·2%) The Stratall trial was a randomised, controlled, open- Yes 97 (54·2%) 96 (50·8%) label, non-inferiority trial done in nine district hospitals in Cameroon. Its design is described in detail elsewhere.12 Active‡ Briefl y, adults infected with HIV, who were treatment- No 74 (44·3%) 73 (42·7%) naive and classifi ed as WHO clinical stages 3 or 4, or Yes 93 (55·7%) 98 (57·3%) WHO clinical stage 2 with a total lymphocyte count of Water supply§ fewer than 1200 cells per μL, were enrolled from May 23, Private tap or mineral water 22 (12·2%) 31 (16·2%) 2006, to Jan 31, 2008, and followed up for 24 months after Public tap 15 (8·3%) 9 (4·7%) ART initiation. At enrolment, participants were randomly Fitted well or bored well with pump 104 (57·8%) 106 (55·5%) allocated (1:1) to receive either laboratory and clinical Purchased or unfi tted well or spring 35 (19·4%) 38 (19·9%) monitoring (LAB; measurement of viral load and CD4 Other 4 (2·2%) 7 (3·7%) cell count plus clinical monitoring) or clinical monitoring WHO clinical stage alone (CLIN). Both groups underwent haematological Stage 2 0 1 (0·5%) and biochemical tests at baseline and during follow-up. Stage 3 140 (74·5%) 147 (74·6%) Clinical monitoring was done in both the LAB and Stage 4 48 (25·5%) 49 (24·9%) CLIN groups every 3 months.
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