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National adult antiretroviral therapy guidelines in resource-limited countries: concordance with 2003 WHO guidelines?
AIDS. 2006 Jul 13; 20(11):1497-1502.The aims were to investigate the existence of national adult antiretroviral therapy (ART) guidelines in 43 World Health Organization (WHO) '3 by 5' focus countries and compare their content with the 2003 WHO ART guidelines. Questionnaires covered initiation of ART, selection of first or second-line ART, monitoring treatment response and toxicity and dissemination of national guidelines. Weighted concordance scores were created and country scores correlated with national indicators and WHO recommendations. Thirty-nine (91%) countries returned questionnaires, three of which had no national ART guidelines. Of the 36, 16 (44%) recommended to start ART based on WHO clinical staging criteria and CD4 cell count or T-lymphocyte count, 12 (33%) WHO clinical staging criteria and CD4 cell count, four (11%) only CD4 cell counts. 35 (97%) recommended a standard first-line regimen and 24 (67%) preferred stavudine + lamivudine + nevirapine; 33 (92%) recommended second-line regimens, and 24 (60%) preferred abacavir + didanosine + lopinavir/ritonavir. Thirty-one (94%) recommended CD4 cell count, possibly combined with other indicators, to monitor ART. Concordance scores were higher in countries with lower health expenditure per capita (P = 0.009) and lower GDP per capita (P < 0.03). Median concordance scores for starting ART was 100 [interquartile range (IQR), 67 to 100]; first line therapy, 70 (IQR, 60 to 80); second-line regimens, 45 (IQR, 27 to 55) and for laboratory investigations, 80 (IQR, 80 to 100). Most countries had developed national ART guidelines as part of a comprehensive national HIV program. Concordance with WHO recommendations was strong on starting first-line ART regimens and routine monitoring but lower for second-line recommendations. (author's)
Evidence behind the WHO guidelines: hospital care for children: what antiretroviral agents and regimens are effective in the prevention of mother-to-child transmission of HIV?
Journal of Tropical Pediatrics. 2006 Aug; 52(4):235-238.The World Health Organization has produced guidelines for the management of common illnesses in hospitals with limited resources. This series reviews the scientific evidence behind WHO's recommendations. This review addresses the question: 'What antiretroviral agents and regimens are effective in the prevention of mother-to-child transmission of HIV?' The WHO Pocketbook of Hospital Care for Children recommends that if an HIV infected woman becomes pregnant she should be provided with services including prophylactic antiretroviral drugs (and Antiretroviral therapy - where clinically indicated), safer obstetric practices and infant-feeding counselling and support. (excerpt)
National adult antiretroviral therapy guidelines in South Africa: concordance with 2003 WHO guidelines?
AIDS. 2007 Jan 2; 21(1):121-122.We read with interest the article by Beck and colleagues who examined the adult antiretroviral therapy (ART) guidelines in 43 World Health Organization (WHO) '3 by 5' focus countries. The authors found that the national guidelines of a majority of countries had a good degree of concordance with the WHO 2003 guidelines. Although concordance was noted to be inversely related to health expenditure per capita, the authors did not further explore the reasons why some countries have adopted guidelines that differ from the current WHO recommendations. One such country is South Africa, which has among the highest per capita income of countries in sub-Saharan Africa and also has much better healthcare infrastructure than most. Despite these resources, the South African national ART programme currently bases its treatment guidelines on the former WHO 2002 guidelines that recommend ART only for patients with WHO stage 4 disease (AIDS) or a blood CD4 cell count of less than 200 cells/ml. We believe these guidelines advocate treatment at too late a stage of disease and that they represent a compromise that may substantially undermine the effectiveness of the programme in the long term. (excerpt)
Antiretroviral treatment and prevention of peripartum and postnatal HIV transmission in West Africa: Evaluation of a two-tiered approach.
PLoS Medicine. 2007 Aug; 4(8):e257.Highly active antiretroviral treatment (HAART) has only been recently recommended for HIV-infected pregnant women requiring treatment for their own health in resource-limited settings. However, there are few documented experiences from African countries. We evaluated the short-term (4 wk) and long-term (12 mo) effectiveness of a two-tiered strategy of prevention of mother-to-child transmission of HIV (PMTCT) in Africa: women meeting the eligibility criteria of the World Health Organization (WHO) received HAART, and women with less advanced HIV disease received short-course antiretroviral (scARV) PMTCT regimens. The MTCT-Plus Initiative is a multi-country, family-centred HIV care and treatment program for pregnant and postpartum women and their families. Pregnant women enrolled in Abidjan, Cote d'Ivoire received either HAART for their own health or short-course antiretroviral (scARV) PMTCT regimens according to their clinical and immunological status. Plasma HIV-RNA viral load (VL) was measured to diagnose peripartum infection when infants were 4 wk of age, and HIV final status was documented either by rapid antibody testing when infants were aged >/= 12 mo or by plasma VL earlier. The Kaplan-Meier method was used to estimate the rate of HIV transmission and HIV-free survival. Between August 2003 and June 2005, 107 women began HAART at a median of 30 wk of gestation, 102 of them with zidovudine (ZDV), lamivudine (3TC), and nevirapine (NVP) and they continued treatment postpartum; 143 other women received scARV for PMTCT, 103 of them with sc(ZDV+3TC) with single-dose NVP during labour. Most (75%) of the infants were breast-fed for a median of 5 mo. Overall, the rate of peripartum HIV transmission was 2.2% (95% confidence interval [CI] 0.3%-4.2%) and the cumulative rate at 12 mo was 5.7% (95% CI 2.5%-9.0%). The overall probability of infant death or infection with HIV was 4.3% (95% CI 1.7%-7.0%) at age week 4 wk and 11.7% (95% CI 7.5%-15.9%) at 12 mo. This two-tiered strategy appears to be safe and highly effective for short- and long-term PMTCT in resource-constrained settings. These results indicate a further benefit of access to HAART for pregnant women who need treatment for their own health. (author's)
Antiretroviral therapy for HIV infection in infants and children: towards universal access. Recommendations for a public health approach.
Geneva, Switzerland, WHO, 2007.  p.These stand-alone treatment guidelines serve as a framework for selecting the most potent and feasible first-line and second-line ARV regimens as components of expanded national responses for the care of HIV-infected infants and children. Recommendations are provided on: diagnosing HIV infection in infants and children; when to start ART, including situations where severe HIV disease in children less than 18 months of age has been presumptively diagnosed; clinical and laboratory monitoring of ART; substitution of ARVs for toxicities. The guidelines consider ART in different situations, e.g. where infants and children are coinfected with HIV and TB or have been exposed to ARVs either for the prevention of MTCT (PMTCT) or because of breastfeeding from an HIV-infected mother on ART. They address the importance of nutrition in the HIV-infected child and of severe malnutrition in relation to the provision of ART. Adherence to therapy and viral resistance to ARVs are both discussed with reference to infants and children. A section on ART in adolescents briefly outlines key issues related to treatment in this age group. (excerpt)
Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach. 2006 revision.
Geneva, Switzerland, WHO, 2006. 127 p.This publication is intended to serve as a reference tool for countries with limited resources as they develop or revise national guidelines for the use of ART in adults and postpubertal adolescents (see Annex 9 for pubertal Tanner staging; prepubertal adolescents should follow the WHO paediatric guidelines). The material presented takes updated evidence into account, including new ART treatment options, and draws on the experience of established ART scale-up programmes. The simplified approach, with evidence-based standards, continues to be the basis of WHO recommendations for the initiation and monitoring of ART. The guidelines are primarily intended for use by national and regional HIV programme managers, managers of nongovernmental organizations delivering HIV care services, and other policy-makers who are involved in the scaling up of comprehensive HIV care and ART in resource-limited countries. The comprehensive, up-to-date technical and clinical information on the use of ART, however, also makes these guidelines useful for clinicians in resource-limited settings. The recommendations contained in these guidelines are made on the basis of different levels of evidence from randomized clinical trials, high-quality scientific studies, observational cohort data and, where insufficient evidence is available, expert opinion. The strengths of the recommendations in Table 1 are intended to indicate the degrees to which the recommendations should be considered by regional and country programmes. Cost-effectiveness is not explicitly considered as part of the recommendations, although the realities of human resources, health system infrastructures and socioeconomic issues should be taken into account when the recommendations are being adapted to regional and country programmes. (excerpt)
Expert Opinion On Pharmacotherapy. 2009 Aug; 10(11):1783-91.BACKGROUND: Treating HIV-infected children remains a challenge due to a lack of treatment options, appropriate drug formulations and, in countries with limited resources, insufficient access to diagnostic tests and treatment. OBJECTIVE: To summarize current data concerning new opportunities to improve the treatment of HIV-infected children. METHODS: This review includes data from the most recently published peer-reviewed publications, guidelines or presentations at international meetings concerning new ways to treat HIV-infected children. RESULTS/CONCLUSIONS: New WHO guidelines recommend starting combination antiretroviral treatment in all infants aged < 1 year. Although this is common practice in some high-income countries, implementation of these recommendations in countries with limited resources is still a challenge. There is still an important gap between the availability of licensed drugs in children compared with adults. There remains a need for further pharmacokinetic studies, and for more pediatric formulations of antiretroviral drugs with improved palatability.
Journal of Acquired Immune Deficiency Syndromes. 2009 Sep 1; 52(1):106-13.BACKGROUND: Current World Health Organization (WHO) guidelines for treatment of HIV in resource-limited settings call for 2 antiretroviral regimens. The effectiveness and cost-effectiveness of increasing the number of antiretroviral regimens is unknown. METHODS: Using a simulation model, we compared the survival and costs of current WHO regimens with two 3-regimen strategies: an initial regimen of 3 nucleoside reverse transcriptase inhibitors followed by the WHO regimens and the WHO regimens followed by a regimen with a second-generation boosted protease inhibitor (2bPI). We evaluated monitoring with CD4 counts only and with both CD4 counts and viral load. We used cost and effectiveness data from Cape Town and tested all assumptions in sensitivity analyses. RESULTS: Over the lifetime of the cohort, 25.6% of individuals failed both WHO regimens by virologic criteria. However, when patients were monitored using CD4 counts alone, only 6.5% were prescribed additional highly active antiretroviral therapy due to missed and delayed detection of failure. The life expectancy gain for individuals who took a 2bPI was 6.7-8.9 months, depending on the monitoring strategy. When CD4 alone was available, adding a regimen with a 2bPI was associated with an incremental cost-effectiveness ratio of $2581 per year of life gained, and when viral load was available, the ratio was $6519 per year of life gained. Strategies with triple-nucleoside reverse transcriptase inhibitor regimens in initial therapy were dominated. Results were sensitive to the price of 2bPIs. CONCLUSIONS: About 1 in 4 individuals who start highly active antiretroviral therapy in sub-Saharan Africa will fail currently recommended regimens. At current prices, adding a regimen with a 2bPI is cost effective for South Africa and other middle-income countries by WHO standards.
Arlington, Virginia, John Snow [JSI], AIDS Support and Technical Assistance Resources [AIDSTAR-One], 2009 Mar. 23 p. (USAID Contract No. GHH-I-00-07-00059-00; AIDSTAR-One Technical Brief)This brief describes WHO recommendations and provides links to useful resources for HIV / AIDS program implementers.
Current Opinion In HIV and AIDS. 2010 Jan; 5(1):38-47.PURPOSE OF REVIEW: Access to first-line antiretroviral therapy in resource-limited settings has increased rapidly in the last 5 years. Newer medicines with greater potency and better safety profiles open the possibility for improving first-line antiretroviral therapy for developing countries. RECENT FINDINGS: Several medicines offer the potential to improve the simplicity, safety and efficacy of first-line antiretroviral therapy in resource-limited settings. These include tenofovir, raltegravir, elvitegravir, rilpivirine and protease inhibitors. A number of clinical questions are outstanding, particularly regarding safety in pregnancy and compatibility with drugs to treat common coinfections including tuberculosis. SUMMARY: Simple, affordable regimens were key to the initial emergency response, but the long-term response to HIV calls for a reconsideration of current treatment options. Preconditions for widespread use in developing countries include affordability, simplicity and answers to relevant research questions. In the absence of strong pharmacovigilance systems, cohort monitoring will be critical to assessing the safety profile of new drugs in such settings.
Geneva, Switzerland, WHO, 2009 Nov. 25 p.Based on the latest scientific evidence, the World Health Organization (WHO) has released new recommendations on HIV treatment and prevention and infant feeding in the context of HIV. WHO now recommends earlier initiation of antiretroviral therapy for adults and adolescents, the delivery of more patient-friendly antiretroviral drugs (ARVs), and prolonged use of ARVs to reduce the risk of mother-to-child transmission of HIV. For the first time, WHO recommends that HIV-positive mothers or their infants take ARVs while breastfeeding to prevent HIV transmission.
Monitoring antiretroviral therapy in resource-limited settings: balancing clinical care, technology, and human resources.
Current HIV / AIDS Reports. 2010 Aug; 7(3):168-74.Due to the rapid expansion of first-line antiretroviral therapy in resource-limited settings (RLS), increasing numbers of people are living with HIV for prolonged periods of time. Treatment programs must now decide how to balance monitoring costs necessary to maximize health benefits for those already on treatment with the continued demand to initiate more patients on first-line treatment. We review currently available evidence related to monitoring strategies in RLS and discuss their implications on timing of switching to second-line treatment, development of HIV resistance, and clinical outcome.
From paper to practice. Implementing the World Health Organization’s 2010 Antiretroviral Therapy Recommendations for Adults and Adolescents in Zambia.
Arlington, Virginia, John Snow [JSI], AIDS Support and Technical Assistance Resources [AIDSTAR-One], 2011 May.  p. (USAID Contract No. GHH-I-00-07-00059-00; AIDSTAR-One Case Study Series)After the 2009 release of WHO’s Rapid Advice for HIV treatment in adults and adolescents, Zambia launched a broad-based effort to update its national treatment protocols. The Ministry of Health succeeded in creating an efficient and inclusive review and revision process for the guidelines, which they began implementing in 2011.
Simplification of antiretroviral therapy: a necessary step in the public health response to HIV/AIDS in resource-limited settings.
Antiviral therapy. 2014; 19 Suppl 3:31-7.The global scale-up of antiretroviral therapy (ART) over the past decade represents one of the great public health and human rights achievements of recent times. Moving from an individualized treatment approach to a simplified and standardized public health approach has been critical to ART scale-up, simplifying both prescribing practices and supply chain management. In terms of the latter, the risk of stock-outs can be reduced and simplified prescribing practices support task shifting of care to nursing and other non-physician clinicians; this strategy is critical to increase access to ART care in settings where physicians are limited in number. In order to support such simplification, successive World Health Organization guidelines for ART in resource-limited settings have aimed to reduce the number of recommended options for first-line ART in such settings. Future drug and regimen choices for resource-limited settings will likely be guided by the same principles that have led to the recommendation of a single preferred regimen and will favour drugs that have the following characteristics: minimal risk of failure, efficacy and tolerability, robustness and forgiveness, no overlapping resistance in treatment sequencing, convenience, affordability, and compatibility with anti-TB and anti-hepatitis treatments.
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2nd ed.
Geneva, Switzerland, WHO, 2016.  p.These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.