Generic fixed-dose combination antiretroviral treatment in resource-poor settings: multicentric observational cohort

Calmy, Alexandra; Pinoges, Lorextu; Szumilin, Elisabeth; Zachariah, Rony; Ford, Nathan; Ferradini, Laurent

doi:10.1097/01.aids.0000226957.79847.d6

Cited by 145 publications

(134 citation statements)

References 20 publications

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“…Whereas several publications (Calmy et al, 2006;Spacek et al, 2006;Wester et al, 2005) and recent presentations from large cohorts in Uganda, Kenya and South Africa (Boulle et al, 2006;Forna et al, 2006;Kim et al, 2006) reported on toxicities such as neuropathy and lactic acidosis, lipoatrophy has not been stated as an important problem and this is in clear contrast to our data (van Griensven et al, 2006). There might be a number of possible reasons for this difference.…”

Section: Discussioncontrasting

confidence: 99%

High prevalence of lipoatrophy among patients on stavudine-containing first-line antiretroviral therapy regimens in Rwanda

Griensven¹,

Naeyer²,

Mushi

et al. 2007

Transactions of the Royal Society of Tropical Medicine and Hygi

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SummaryThis study was conducted among individuals placed on WHO-recommended firstline antiretroviral therapy (ART) at two urban health centres in Kigali, Rwanda, in order to determine (a) the overall prevalence of lipodystrophy and (b) the risk factors for lipoatropy. Consecutive individuals on ART for >1 year were systematically subjected to a standardised case definition-based questionnaire and clinical assessment. Of a total of 409 individuals, 370 (90%) were on an ART regimen containing stavudine (d4T), whilst the rest were receiving a zidovudine (AZT)-containing regimen. Lipodystrophy was apparent in 140 individuals (34%), of whom 40 (9.8%) had isolated lipoatrophy, 20 (4.9%) had isolated lipohypertrophy and 80 (19.6%) had mixed patterns. Fifty-six percent of patients reported the effects as disturbing. The prevalence of lipoatrophy was more than three times higher when taking d4T compared with AZT-containing regimens (31.4% vs. 10.3%). Being female, d4T-based ART, baseline body mass index ≥25 kg/m 2 or baseline CD4 count ≥150 cells/ l and increasing duration of ART were all significantly associated with lipoatrophy. Lipoatrophy appears to be an important long-term complication of WHO-recommended first-line ART regimens. These data highlight the urgent need for access to more affordable and less toxic ART regimens in resource-limited settings.

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Section: Discussioncontrasting

confidence: 99%

High prevalence of lipoatrophy among patients on stavudine-containing first-line antiretroviral therapy regimens in Rwanda

Griensven¹,

Naeyer²,

Mushi

et al. 2007

Transactions of the Royal Society of Tropical Medicine and Hygi

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“…While other cohort data from the IDI [29] and other African centres [3,43-46] have reported excellent 12-month outcomes, this result is likely to have been affected by survival bias. Due to the cross-sectional nature of this study, our results may not account for early losses to follow up (from deaths, etc.)…”

Section: Discussionmentioning

confidence: 80%

Development and evaluation of a clinical algorithm to monitor patients on antiretrovirals in resource-limited settings using adherence, clinical and CD4 cell count criteria

Meya

Spacek

Tibenderana

et al. 2009

Journal of the International AIDS Society

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BackgroundRoutine viral load monitoring of patients on antiretroviral therapy (ART) is not affordable in most resource-limited settings.MethodsA cross-sectional study of 496 Ugandans established on ART was performed at the Infectious Diseases Institute, Kampala, Uganda. Adherence, clinical and laboratory parameters were assessed for their relationship with viral failure by multivariate logistic regression. A clinical algorithm using targeted viral load testing was constructed to identify patients for second-line ART. This algorithm was compared with the World Health Organization (WHO) guidelines, which use clinical and immunological criteria to identify failure in the absence of viral load testing.ResultsForty-nine (10%) had a viral load of >400 copies/mL and 39 (8%) had a viral load of >1000 copies/mL. An algorithm combining adherence failure (interruption >2 days) and CD4 failure (30% fall from peak) had a sensitivity of 67% for a viral load of >1000 copies/mL, a specificity of 82%, and identified 22% of patients for viral load testing. Sensitivity of the WHO-based algorithm was 31%, specificity was 87%, and would result in 14% of those with viral suppression (<400 copies/mL) being switched inappropriately to second-line ART.ConclusionAlgorithms using adherence, clinical and CD4 criteria may better allocate viral load testing, reduce the number of patients continued on failing ART, and limit the development of resistance.

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“…8,10,11 The majority of patients in our cohort were treated with split adult FDC of 2 NRTIs and 1 NNRTI, confirming other findings that good outcomes can be achieved with this treatment strategy. 18,19 It should be noted, however, that this practice is a suboptimal interim strategy 13 pending prequalification of pediatric formulations of FDCs. The majority of the patients were in an advanced stage of HIV infection, similar to many settings where HIV/AIDS care for children has been commenced.…”

Section: Discussionmentioning

confidence: 99%

Effectiveness of Highly Active Antiretroviral Therapy in HIV-Positive Children: Evaluation at 12 Months in a Routine Program in Cambodia

Janssens¹,

Raleigh²,

Soeung

et al. 2007

Pediatrics

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OBJECTIVE. Increasing access to highly active antiretroviral therapy to reach all those in need in developing countries (scale up) is slowly expanding to HIV-positive children, but documented experience remains limited. We aimed to describe the clinical, immunologic, and virologic outcomes of pediatric patients with >12 months of highly active antiretroviral therapy in 2 routine programs in Cambodia. METHODS. Between June 2003 and March 2005, 212 children who were younger than 13 years started highly active antiretroviral therapy. Most patients started a standard first-line regimen of lamivudine, stavudine, and nevirapine, using split adult fixed-dosage combinations. CD4 percentage and body weight were monitored routinely. A cross-sectional virologic analysis was conducted in January 2006; genotype resistance testing was performed for patients with a detectable viral load. RESULTS. Mean age of the subjects was 6 years. Median CD4 percentage at baseline was 6. Survival was 92% at 12 months and 91% at 24 months; 13 patients died, and 4 were lost to follow-up. A total of 81% of all patients had an undetectable viral load. Among the patients with a detectable viral load, most mutations were associated with resistance to lamivudine and non–nucleoside reverse-transcriptase inhibitor drugs. Five patients had developed extensive antiretroviral resistance. Being an orphan was found to be a predictor of virologic failure. CONCLUSIONS. This study provides additional evidence of the effectiveness of integrating HIV/AIDS care with highly active antiretroviral therapy for children in a routine setting, with good virologic suppression and immunologic recovery achieved by using split adult fixed-dosage combinations. Viral load monitoring and HIV genotyping are valuable tools for the clinical follow-up of the patients. Orphans should receive careful follow-up and extra support.

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Generic fixed-dose combination antiretroviral treatment in resource-poor settings: multicentric observational cohort

Abstract: Positive outcomes for d4T/3TC/NVP are reported for up to 18 months in terms of efficacy and safety.

Cited by 145 publications

References 20 publications

High prevalence of lipoatrophy among patients on stavudine-containing first-line antiretroviral therapy regimens in Rwanda

High prevalence of lipoatrophy among patients on stavudine-containing first-line antiretroviral therapy regimens in Rwanda

Development and evaluation of a clinical algorithm to monitor patients on antiretrovirals in resource-limited settings using adherence, clinical and CD4 cell count criteria

Effectiveness of Highly Active Antiretroviral Therapy in HIV-Positive Children: Evaluation at 12 Months in a Routine Program in Cambodia

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