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Contraceptive method considerations for clients with HIV including those on ART: provider reference tool.
[Washington, D.C.], FHI 360, 2017 Nov. 2 p.This is an at-a-glance resource for clinical providers to determine whether clients with HIV, including those on antiretroviral therapy (ART), may initiate or continue using common contraceptive methods. This chart is based on the World Health Organization's Medical Eligibility Criteria for Contraceptive Use (2016). The tool provides foundational information for clinical providers on how the effectiveness of different types of hormonal contraceptive methods is affected by interaction with antiretroviral drugs. It also provides guidance on how to promote informed decision-making and help women with HIV who are taking antiretroviral drugs use their chosen hormonal contraceptive method successfully.
Has the phasing out of stavudine in accordance with changes in WHO guidelines led to a decrease in single-drug substitutions in first-line antiretroviral therapy for HIV in sub-Saharan Africa?
AIDS. 2017 Jan 2; 31(1):147-157.OBJECTIVE: We assessed the relationship between phasing out stavudine in first-line antiretroviral therapy (ART) in accordance with WHO 2010 policy and single-drug substitutions (SDS) (substituting the nucleoside reverse transcriptase inhibitor in first-line ART) in sub-Saharan Africa. DESIGN: Prospective cohort analysis (International epidemiological Databases to Evaluate AIDS-Multiregional) including ART-naive, HIV-infected patients aged at least 16 years, initiating ART between January 2005 and December 2012. Before April 2010 (July 2007 in Zambia) national guidelines called for patients to initiate stavudine-based or zidovudine-based regimen, whereas thereafter tenofovir or zidovudine replaced stavudine in first-line ART. METHODS: We evaluated the frequency of stavudine use and SDS by calendar year 2004-2014. Competing risk regression was used to assess the association between nucleoside reverse transcriptase inhibitor use and SDS in the first 24 months on ART. RESULTS: In all, 33 441 (8.9%; 95% confience interval 8.7-8.9%) SDS occurred among 377 656 patients in the first 24 months on ART, close to 40% of which were amongst patients on stavudine. The decrease in SDS corresponded with the phasing out of stavudine. Competing risks regression models showed that patients on tenofovir were 20-95% less likely to require a SDS than patients on stavudine, whereas patients on zidovudine had a 75-85% decrease in the hazards of SDS when compared to stavudine. CONCLUSION: The decline in SDS in the first 24 months on treatment appears to be associated with phasing out stavudine for zidovudine or tenofovir in first-line ART in our study. Further efforts to decrease the cost of tenofovir and zidovudine for use in this setting is warranted to substitute all patients still receiving stavudine.
[HIV-1 resistance to antiretroviral drugs in pregnant women from Buenos Aires metropolitan area] Resistencia de HIV-1 a drogas antirretrovirales en gestantes del area Metropolitana de Buenos Aires.
Medicina. 2016; 76(6):349-354.The study aimed to determine the prevalence of antiretroviral resistance associated mutations in HIV-1 infected pregnant woman treated in Buenos Aires metropolitan area (period 2008-2014). A total of 136 women with viral load = 500 copies/ml were included: 77 (56.6%) were treatment-naive and 59 (43.4%) were antiretroviral-experienced patients either with current (n: 24) or previous (n = 35) antiretroviral therapy. Genotypic baseline resistance was investigated in plasma of antiretroviral-naive patients and antiretroviral-experienced patients. The resistance mutations were identified according to the lists of the World Health Organization and the International Antiviral Society, respectively. Frequencies of resistance associated mutations detected in 2008-2011 and 2012-2014 were compared. A total of 37 (27.2%) women presented at least one resistance associated mutation: 25/94 (26.5%) in 2008-2011 and 12/42 (28.5%) in 2012-2014 (p > 0.05). Among naives, 15 (19.5%) had at least one mutation: 10/49 (20.4%) in the period 2008-2011 and 5/28 (17.8%) in 2012-2014 (p > 0.05). The resistance mutations detected in naives were associated with non nucleoside reverse transcriptase inhibitors, being K103N the most common mutation in both periods. In antiretroviral experienced patients, 22/59 (37.3%) had at least one resistance mutation. This study demonstrates a high frequency of resistance associated mutations which remained stable in the period analyzed. These levels suggest an increased circulation of HIV-1 antiretroviral resistant strains in our setting compared to previous reports from Argentina.
Expert Review of Clinical Pharmacology. 2016 Aug 22; 9(11):1493-1503.Introduction: WHO recommends tenofovir, efavirenz, and lamivudine or emtricitabine for first-line antiretroviral therapy (ART) in adults, which replaced more toxic regimens using stavudine, zidovudine or nevirapine. Areas covered: We searched Pubmed to identify observational studies and randomized controlled trials reporting toxicity of these antiretrovirals published between 2011 and 2016, and hand-searched abstracts presented at major HIV conferences in 2015 and 2016, focusing on data from sub-Saharan Africa. Tenofovir’s nephrotoxicity manifests as mild renal tubular dysfunction (common and of uncertain clinical significance), acute kidney injury (rare), and chronic declining glomerular filtration rate (common). African studies, which include high proportions of patients with renal dysfunction from opportunistic diseases, report population improvement in renal function after starting tenofovir-based ART. Tenofovir modestly decreases bone mineral density, and there is emerging data that this increases fracture risk. Efavirenz commonly causes early self-limiting neuropsychiatric toxicity and hypersensitivity rashes. Recent studies have highlighted its long-term neuropsychiatric effects, notably suicidality and neurocognitive impairment, and metabolic toxicities (dyslipidemia, dysglycemia, and lipoatrophy). We point out the challenges clinicians face in the recognition and attribution of adverse drug reactions. Expert commentary: Tenofovir and efavirenz are generally well tolerated, but both are associated with potentially serious toxicities. Pharmacovigilance systems in resource-limited settings with high HIV burden should be strengthened.
Short Communication: Population-Based Surveillance of HIV-1 Drug Resistance in Cameroonian Adults Initiating Antiretroviral Therapy According to the World Health Organization Guidelines.
AIDS Research and Human Retroviruses. 2016 Apr; 32(4):329-33.With ongoing earlier enrollment on and rapid scale-up of antiretroviral therapy (ART) in Cameroon, there are increasing risks of transmitted HIV drug resistance (HIVDR) at population levels. We, therefore, evaluated the threshold of HIVDR in a population initiating ART, to inform on the effectiveness of first-line regimens, considering HIV-1 diversity, plasma viral load (PVL), and CD4-based disease progression. A total of 53 adults [median (interquartile range, IQR) CD4: 162 cell/mm(3) (48-284); median (IQR) PVL: 5.34 log10 RNA (4.17-6.42) copies/ml] initiating ART in 2014 at the Yaounde Central Hospital were enrolled for HIV-1 protease-reverse transcriptase sequencing. Drug resistance mutations (DRMs) were interpreted using the 2009 World Health Organization (WHO) list versus the Stanford HIVdb algorithm version 7.0. Level of DRMs was low (3.77%) versus moderate (7.55%), respectively, following the WHO list (T69D, K103N) versus Stanford HIVdb (T69D, A98G, K103N, K238T), respectively. Prevailing clade was CRF02_AG (71.70%). Based on Stanford HIVdb, a slightly higher proportion of patients with DRMs were found among ones infected with CRF02_AG than in those non-CRF02_AG infected (7.89% vs. 6.67%, p = 1.000), with lower PVL (7.69% <5.5 vs. 0% >/=5.5 log10 RNA copies/ml, p = .488) and with higher CD4 counts (9.52% CD4 >/=200 vs. 3.33% CD4 <200 cells/mm(3), p = .749). Thresholds of DRMs suggest that standard first-line regimens currently used in Cameroon may remain effective at population levels, despite scale-up of ART in the country, pending adherence, and closed virological monitoring. With an intent-to-diagnose approach, the discrepant levels of DRMs support using Stanford HIVdb to evaluate initial ART, while revising the WHO list for surveillance.
Performance of Risk Charts to Guide Targeted HIV Viral Load Monitoring of ART: Applying the Method on the Data From a Multicenter Study in Rural Lesotho.
Journal of Acquired Immune Deficiency Syndromes. 2016 May 1; 72(1):e22-5.Add to my documents.
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.
Guideline: Updates on HIV and infant feeding. The duration of breastfeeding and support from health services to improve feeding practices among mothers living with HIV.
Geneva, Switzerland, WHO, 2016.  p.The objective of this guideline is to improve the HIV-free survival of HIV-exposed infants by providing guidance on appropriate infant feeding practices and use of ARV drugs for mothers living with HIV and by updating WHO-related tools and training materials. The guideline is intended mainly for countries with high HIV prevalence and settings in which diarrhoea, pneumonia and undernutrition are common causes of infant and child mortality. However, it may also be relevant to settings with a low prevalence of HIV depending on the background rates and causes of infant and child mortality. This guideline aims to help Member States and their partners in their efforts to make informed decisions on the appropriate nutrition actions to achieve the Sustainable Development Goals, the global targets set in the comprehensive implementation plan on maternal, infant and young child nutrition, the Global Strategy for Women’s, Children’s and Adolescents’ Health (2016-2030) and the Global Health Sector Strategy on Sexually Transmitted Infections 2016-2021. The target audience for this guideline includes: (1) national policy-makers in health ministries; (2) programme managers working in child health, essential drugs and health worker training; (3) health-care providers, researchers and clinicians providing services to pregnant women and mothers living with HIV at various levels of health care; and (4) development partners providing financial and/or technical support for child health programmes, including those in conflict and emergency settings. (Excerpt)
Geneva, Switzerland, WHO, 2015 Sep.  p. (Guidelines)This early-release guideline makes available two key recommendations that were developed during the revision process in 2015. First, antiretroviral therapy (ART) should be initiated in everyone living with HIV at any CD4 cell count. Second, the use of daily oral pre-exposure prophylaxis (PrEP) is recommended as a prevention choice for people at substantial risk of HIV infection as part of combination prevention approaches. The first of these recommendations is based on evidence from clinical trials and observational studies released since 2013 showing that earlier use of ART results in better clinical outcomes for people living with HIV compared with delayed treatment. The second recommendation is based on clinical trial results confirming the efficacy of the ARV drug tenofovir for use as PrEP to prevent people from acquiring HIV in a wide variety of settings and populations. The recommendations in this guideline will form part of the revised consolidated guidelines on the use of ARV drugs for treating and preventing HIV infection to be published by WHO in 2016. The full update of the guidelines will consist of comprehensive clinical recommendations together with revised operational and service delivery guidance to support implementation.
Antiviral therapy. 2014; 19 Suppl 3:1.Add to my documents.
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.
Adoption of national recommendations related to use of antiretroviral therapy before and shortly following the launch of the 2013 WHO consolidated guidelines.
AIDS. 2014 Mar; 28 Suppl 2:S217-24.OBJECTIVE: To determine the status of key national policies on the use of antiretroviral therapy (ART) at the time of the launch of the 2013 WHO consolidated guidelines as well as to track early progress towards adoption of these recommendations following dissemination. DESIGN: Descriptive analysis of global data on baseline ART policies as of June 2013 and early intentions to adopt the 2013 WHO for use of antiretroviral drugs guidelines as of November 2013. METHODS: Compilation of existing global reports on key HIV policies, review of national guidelines, data collection through annual drug procurement surveys and through guidelines dissemination meetings in each of the six WHO regions. RESULTS: Data were available from 124 low- and middle-income countries, including 97% of the 57 high-priority countries that have been identified by WHO and the Joint United Nations Program on HIV/AIDS (UNAIDS). At baseline, only one country reported recommending antiretroviral therapy (ART) at a CD4 T-cell count 250 cells/mul or less for adults and adolescents in 2013, whereas nine countries already recommended using CD4 T-cell count 500 cells/mul or less. Recommendations for ART initiation regardless of CD4 T-cell count for HIV-infected patients with tuberculosis (86%), hepatitis B (75%), all HIV-infected women who were pregnant or breastfeeding (option B+: 40%) or HIV-infected persons in a serodiscordant relationship (26%) had been nationally adopted as of June 2013. Eight of 67 countries (12%) already recommended treating all children less than 5 years of age. The triple antiretroviral combination of tenofovir + lamivudine (or emtricitabine) + efavirenz was recommended as the preferred first-line option for adults and adolescents more frequently (51%) than for pregnant women (38%), or for both adults/adolescents and pregnant women (28%; P < 0.05). Fewer than half (37%) of all countries reported recommending lopinavir/ritonavir for all HIV-infected children less than 3 years of age; 54% of countries reported recommending routine viral load monitoring, whereas only 41% recommended nurse-initiated ART. CONCLUSIONS: A number of key WHO policy recommendations on antiretroviral drug use were adopted rapidly by countries in advance of or shortly following the launch of the 2013 guidelines. Efforts are needed to support and track ongoing policy adoption and ensure that it is accompanied by the scale-up of evidence-based interventions.
Evaluation of the impact of immediate versus WHO recommendations-guided antiretroviral therapy initiation on HIV incidence: the ANRS 12249 TasP (Treatment as Prevention) trial in Hlabisa sub-district, KwaZulu-Natal, South Africa: study protocol for a cluster randomised controlled trial.
Trials. 2013; 14:230.BACKGROUND: Antiretroviral therapy (ART) suppresses HIV viral load in all body compartments and so limits the risk of HIV transmission. It has been suggested that ART not only contributes to preventing transmission at individual but potentially also at population level. This trial aims to evaluate the effect of ART initiated immediately after identification/diagnosis of HIV-infected individuals, regardless of CD4 count, on HIV incidence in the surrounding population. The primary outcome of the overall trial will be HIV incidence over two years. Secondary outcomes will include i) socio-behavioural outcomes (acceptability of repeat HIV counselling and testing, treatment acceptance and linkage to care, sexual partnerships and quality of life); ii) clinical outcomes (mortality and morbidity, retention into care, adherence to ART, virologic failure and acquired HIV drug resistance), iii) cost-effectiveness of the intervention. The first phase will specifically focus on the trial's secondary outcomes. METHODS/DESIGN: A cluster-randomised trial in 34 (2 x 17) clusters within a rural area of northern KwaZulu-Natal (South Africa), covering a total population of 34,000 inhabitants aged 16 years and above, of whom an estimated 27,200 would be HIV-uninfected at start of the trial. The first phase of the trial will include ten (2 x 5) clusters. Consecutive rounds of home-based HIV testing will be carried out. HIV-infected participants will be followed in dedicated trial clinics: in intervention clusters, they will be offered immediate ART initiation regardless of CD4 count and clinical stage; in control clusters they will be offered ART according to national treatment eligibility guidelines (CD4 <350 cells/muL, World Health Organisation stage 3 or 4 disease or multidrug-resistant/extensively drug-resistant tuberculosis). Following proof of acceptability and feasibility from the first phase, the trial will be rolled out to further clusters. DISCUSSION: We aim to provide proof-of-principle evidence regarding the effectiveness of Treatment-as-Prevention in reducing HIV incidence at the population level. Data collected from the participants at home and in the clinics will inform understanding of socio-behavioural, economic and clinical impacts of the intervention as well as feasibility and generalizability. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01509508; South African Trial Register: DOH-27-0512-3974.
BMJ. 2013; 347:f4172.Add to my documents.
Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: Recommendations for a public health approach.
Geneva, Switzerland, WHO, 2013.  p.The 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection provide new guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the care of people living with HIV and the use of antiretroviral (ARV) drugs for treating and preventing HIV infection.
Efavirenz conceptions and regimen management in a prospective cohort of women on antiretroviral therapy.
Infectious Diseases In Obstetrics and Gynecology. 2012; 2012:723096.Use of the antiretroviral drug efavirenz (EFV) is not recommended by the WHO or South African HIV treatment guidelines during the first trimester of pregnancy due to potential fetal teratogenicity; there is little evidence of how clinicians manage EFV-related fertility concerns. Women on antiretroviral therapy (ART) were enrolled into a prospective cohort in four public clinics in Johannesburg, South Africa. Fertility intentions, ART regimens, and pregnancy testing were routinely assessed during visits. Women reporting that they were trying to conceive while on EFV were referred for regimen changes. Kaplan-Meier estimators were used to assess incidence across ART regimens. From the 822 women with followup visits between August 2009-March 2011, 170 pregnancies were detected during study followup, including 56 EFV conceptions. Pregnancy incidence rates were comparable across EFV, nevirapine, and lopinavir/ritonavir person-years (95% 100/users (P=0.25)); incidence rates on EFV were 18.6 Confidence Interval: 14.2-24.2). Treatment substitution from EFV was made for 57 women, due to pregnancy intentions or actual pregnancy; however, regimen changes were not systematically applied across women. High rates of pregnancy on EFV and inconsistencies in treatment management suggest that clearer guidelines are needed regarding how to manage fertility-related issues in. women on EFV-based regimens.
World Health Organization's 2010 recommendations for HIV treatment: Natiional guideline revision challenges and lessons learned.
Arlington, Virginia, John Snow [JSI], AIDS Support and Technical Assistance Resources [AIDSTAR-One], 2012 Feb.  p. (Technical Brief; USAID Contract No. GHH-I-00–07–00059–00)In 2010, the World Health Organization released revised recommendations for adult and adolescent HIV treatment. This technical brief provides HIV policy makers and program managers with a point of reference as they adapt and implement revised national HIV treatment guidelines. Approaches that worked well, challenges and lessons learned from Sub-Saharan Africa, Latin America, and South-East Asia are highlighted. Links to key resources for countries revising guidelines and implementing revisions are also provided.
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.
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.
Journal of Health Care Finance. 2010; 36(4):75-79.When the United Nations declared "health care for all" (at the conferences at Alma-Ata in 1978 and the Ottawa Charter in 1986),(1) the declarations were largely premature to impact the upcoming HIV/AIDS epidemic. These UN declarations still apply today, as multitudes of humanity continue to die from what amounts now to be a treatable chronic disease. Can the wealthier, industrialized countries stand by and watch the decimation of the populations of the developing world by HIV / AIDS? The global "health 9/10 gap," relates that only 10 percent of global heath resources go to developing countries - i.e., those having 90 percent of the poorest world populations. (2) The World Bank/World Health Organization has been at the forefront of providing resources for the global HIV/AIDS epidemic, (3) but for many countries of the developing world (especially Sub-Saharan Africa) it may be too little, too late. This work explores the application of an ecological model to global policy against HIV/AIDS, highlighting access to antiretroviral drugs (ARV). ARV distribution is constrained by patents and laws protecting the intellectual property rights of the international pharmaceutical corporations. In response to this situation, more questions arise. Will governments in the developing world invoke compulsory licensing (patent-breaking) in their negotiations with the international pharmaceutical corporations to provide medications against HIV/AIDS in their countries? Can international political and financial negotiations with these pharmaceutical corporations speed the growing push for a solution to this solvable crisis? The answers may lie in the "Brazilian model," that is a developing world government using all means available to provide ARV drugs for all its citizens with HIV/AIDS. The basis of this model includes negotiating with the pharmaceutical corporations over patent rights and importation of copied drugs from the Far East.
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.
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.
Indian Journal of Pediatrics. 2009 Oct; 76(10):1017-21.OBJECTIVE: To assess the metabolic drug toxicities of first-line, World Health Organization (WHO)-recommended generic highly active antiretroviral therapy (HAART) regimens, to estimate the prevalence of body fat redistribution and to identify associated risk factors. METHODS: Cross-sectional observational study. During 3 month period, 52 HIV infected children (25 on HAART; 27 not on HAART) were assessed. Their sociodemographic, clinical, and immunological data was recorded. Children were examined or the signs of fat redistribution (peripheral lipoatrophy and central lipohypertrophy). Liver function tests, fasting blood sugar, lipid profile, serum amylase, serum lactate, blood pH and bicarbonate levels were done in all patients. RESULTS: Twenty-two patients were on stavudine and three on zidovudine based HAART. None of the patients ever received any protease inhibitor. There were no cases of clinical or immunological failure. Children on HAART had significantly lower weight for age and body mass index but the mean height for age was similar between study groups. Only two cases of peripheral lipoatrophy were observed. Hypercholesterolemia was observed in four children on HAART but none without therapy. Hypertriglyceridemia was observed in three children on HAART and seven without therapy. Four cases of asymptomatic mild hyperlactatemia were observed. No case of any hyperglycemia or liver impairment was observed. CONCLUSION: Metabolic abnormalities and lipodystrophy are emerging complications of HAART in Indian children and needs very close follow up. Future studies with larger sample size and longitudinal model are recommended.
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.
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.