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Risk and prognostic significance of tuberculosis in patients from The TREAT Asia HIV Observational Database
Jialun Zhou, Julian Elliott, Patrick CK Li, Poh Lim, Sasisopin Kiertiburanakul, Nagalingeswaran Kumarasamy, Tuti Merati, Sanjay Pujari, Yi-Ming A Chen, Praphan Phanuphak, Saphonn Vonthanak, Thira Sirisanthana, Somnuek Sungkanuparph, Christopher KC Lee, Adeeba Kamarulzaman, Shinichi Oka, Fujie Zhang, Goa Tau, Rossana Ditangco
BMC Infectious Diseases , 2009, DOI: 10.1186/1471-2334-9-46
Abstract: The risk of TB diagnosis after recruitment was assessed in patients with prospective follow-up. TB diagnosis was fitted as a time-dependent variable in assessing overall survival.At baseline, 22% of patients were diagnosed with TB. TB incidence was 1.98 per 100 person-years during follow up, with predictors including younger age, lower recent CD4 count, duration of antiretroviral treatment, and living in high TB burden countries. Among 3279 patients during 6968 person-years, 142 died (2.04 per 100 person-years). Compared to patients with CDC category A or B illness only, mortality was marginally higher in patients with single Non-TB AIDS defining illness (ADI), or TB only (adjusted HR 1.35, p = 0.173) and highest in patients with multiple non-TB AIDS or both TB and other ADI (adjusted HR 2.21, p < 0.001).The risk of TB diagnosis was associated with increasing immunodeficiency and partly reduced by antiretroviral treatment. The prognosis of developing TB appeared to be similar to that following a diagnosis of other non-TB ADI.The use of highly active antiretroviral therapy (HAART) has led to dramatic reductions in morbidity and mortality in HIV patients [1,2]. However, tuberculosis (TB) remains a common opportunistic infections and a major cause of death among patients with HIV, especially in sub-Saharan African and Asian countries [3-5], where there is a high background prevalence of TB [5-7].The risk of TB in HIV-infected patients and the impact of TB diagnosis on disease progression in HIV infected patients have been well described in Africa [3,8-10]. The Asia-Pacific region has a large burden of both tuberculosis [7], with nearly 5 million prevalent cases and over 3 million new cases in 2006, and HIV, with an estimated 5 million people living with HIV and 380,000 new infections occurring in 2007 [11]. It is estimated that 2.5 million people are living with both infections in the region [5]. Despite the importance of these inter-related epidemics in the region, fe
Baseline severe anaemia should not preclude use of zidovudine in antiretroviral-eligible patients in resource-limited settings
Kiragga Agnes N,Castelnuovo Barbara,Nakanjako Damalie,Manabe Yukari C
Journal of the International AIDS Society , 2010, DOI: 10.1186/1758-2652-13-42
Abstract: Background Stavudine is no longer recommended as part of first-line therapy for patients initiating antiretroviral therapy (ART) in Uganda. Most patients are currently initiated on zidovudine-containing regimens, which can induce anaemia. We investigated the risk factors for early severe anaemia in the first six months of ART initiation. Methods We defined baseline (ART initiation) anaemia as haemoglobin (Hb) ≤9.5 g/dL, baseline severe anaemia as Hb ≤8 g/dL, and early severe anaemia as Hb ≤8 g/dL within six months of ART initiation. Risk factors for the development of early severe anaemia were analyzed using a multivariable logistic regression model. Results In total, 5494 patients initiated ART, 821 (15%) had baseline anaemia, and 296 (5%) had baseline severe anaemia. Early severe anaemia occurred in 109 (4%) of 3105 patients who had at least one Hb measurement in the first six months on ART. Patients with baseline anaemia had a larger increase in Hb (median g/dL [IQR]) within the first six months compared with non-anaemic patients (2.9 [1.7, 4.6] vs. 0.7 [-0.2, 1.7], p < 0.0001). Having a new tuberculosis episode OR 3.69 (95% CI 1.64 - 8.32), MCV <80fL OR 1.60 (95% CI 1.01- 2.52) and baseline severe anaemia OR 5.27 (95% CI 3.00 - 9.26) were associated with early severe anaemia. Initiation on a zidovudine-based regimen was not associated with an increased risk of early severe anaemia. Conclusions Among patients in an urban HIV clinic in Uganda, severe anaemia is modestly prevalent at ART initiation and improves with ART in the majority of patients. These data suggest that baseline severe anaemia should not be used as a criterion for avoiding the use of zidovudine in patients initiating ART in resource-limited settings.
Modeling AIDS survival after initiation of antiretroviral treatment by Weibull models with changepoints
Yiannoutsos Constantin T
Journal of the International AIDS Society , 2009, DOI: 10.1186/1758-2652-12-9
Abstract: Background Mortality of HIV-infected patients initiating antiretroviral therapy in the developing world is very high immediately after the start of ART therapy and drops sharply thereafter. It is necessary to use models of survival time that reflect this change. Methods In this endeavor, parametric models with changepoints such as Weibull models can be useful in order to explicitly model the underlying failure process, even in the case where abrupt changes in the mortality rate are present. Estimation of the temporal location of possible mortality changepoints has important implications on the effective management of these patients. We briefly describe these models and apply them to the case of estimating survival among HIV-infected patients who are initiating antiretroviral therapy in a care and treatment programme in sub-Saharan Africa. Results As a first reported data-driven estimate of the existence and location of early mortality changepoints after antiretroviral therapy initiation, we show that there is an early change in risk of death at three months, followed by an intermediate risk period lasting up to 10 months after therapy. Conclusion By explicitly modelling the underlying abrupt changes in mortality risk after initiation of antiretroviral therapy we are able to estimate their number and location in a rigorous, data-driven manner. The existence of a high early risk of death after initiation of antiretroviral therapy and the determination of its duration has direct implications for the optimal management of patients initiating therapy in this setting.
Complications of Antiretroviral Therapy Initiation in Hospitalised Patients with HIV-Associated Tuberculosis  [PDF]
Helen van der Plas, Graeme Meintjes, Charlotte Schutz, Rene Goliath, Landon Myer, Dorothea Baatjie, Robert J. Wilkinson, Gary Maartens, Marc Mendelson
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0054145
Abstract: Background HIV-associated tuberculosis is a common coinfection in Sub-Saharan Africa, which causes high morbidity and mortality. A sub-set of HIV-associated tuberculosis patients require prolonged hospital admission, during which antiretroviral therapy initiation may be required. The aim of this study was to document the causes of clinical deterioration of hospitalised patients with HIV-associated tuberculosis starting antiretroviral therapy in order to inform healthcare practice in low- to middle-income countries. Methods Prospective, observational cohort study of adult inpatients with HIV-associated tuberculosis starting antiretroviral therapy in a dedicated tuberculosis hospital in Cape Town, South Africa. Causes of clinical deterioration and outcome were recorded in the first 12 weeks of antiretroviral therapy. Patients with rifampicin-resistant tuberculosis were excluded. Results Between May 2009 and November 2010, 112 patients (60% female), with a median age of 32 years were enrolled. At baseline the median CD4 count was 55 cells/mm3 (IQR 31–106) and HIV viral load 5.6 log copies/mL. All patients had significant comorbidity: 82% were bed-bound, 65% had disseminated tuberculosis and 27% had central nervous system tuberculosis. Seventy six patients (68%) developed 144 clinical events after starting antiretroviral therapy. TB-IRIS, hospital-acquired infections and significant drug toxicities occurred in 42%, 20.5% and 15% of patients respectively. A new opportunistic disease occurred in 15% of patients and a thromboembolic event in 8%. Mortality during the 12 week period was 10.6%. Conclusions High rates of TB-IRIS, hospital-acquired infections and drug toxicities complicate the course of patients with HIV-associated tuberculosis starting antiretroviral therapy in hospital. Despite the high morbidity, mortality was relatively low. Careful clinical management and adequate resources are needed in hospitalised HIV-TB patients in the 1st three months following ART initiation.
Differences in Lipid Measurements by Antiretroviral Regimen Exposure in Cohorts from Asia and Australia  [PDF]
Amit C. Achhra,Janaki Amin,Jennifer Hoy,Junko Tanuma,Thira Sirisanthana,David Nolan,Tuti Merati,Michelle Giles
AIDS Research and Treatment , 2012, DOI: 10.1155/2012/246280
Abstract: We explored the mean differences in routinely measured lipids (total cholesterol, triglycerides, and high-density lipoprotein cholesterol) according to exposure to different combination antiretroviral regimens in Asian ( ) and Australian (predominantly Caucasian, ) cohorts. The regimen was defined as at least 3 antiretroviral drugs with at least 2 nucleoside-reverse transcriptases (NRTIs) and either of at least one protease inhibitor (PI) or non-nucleoside-reverse transcriptases (NNRTIs). We categorised cART regimens as: NRTIs as tenofovir based or not; NNRTIs as nevirapine or efavirenz (but not both); and PI as atazanavir based or not. We found that the impact of various antiretroviral regimens on lipids in Asian and Australian cohorts was only different by cohort for total cholesterol ( for interaction between regimen and cohort: <0.001) but not in case of other lipids ( for interaction: >0.05). The differences in total cholesterol were however small and unlikely to be of clinical significance. Overall, tenofovir with nevirapine or atazanavir was associated with the most favorable lipids, while the PI regimens without tenofovir and atazanavir were associated with least favorable lipids. We conclude that the impact of various ART regimens on lipids is largely similar in Asian and Australian cohorts and that the newer drugs such as tenofovir and atazanavir are likely to provide similar benefit in terms of lipid profiles in both populations. 1. Introduction Combination antiretroviral therapy (cART) for HIV infection is associated with adverse changes in lipid profiles and can include elevation in total cholesterol and triglycerides, which may increase the risk of coronary heart disease (CHD) [1–4]. Moreover, different classes of cART and drugs within each class have differential impacts on lipids [2]. Protease-inhibitors (PIs) are associated with more significant changes in lipid profile than nucleoside and nonnucleoside reverse transcriptase inhibitors (NRTIs and NNRTIs, resp.) [2, 3, 5]. And within NNRTI class, efavirenz (EFV) is associated with greater changes in the lipid profile than nevirapine (NVP) [2, 5, 6]. Also tenofovir (TDF) and atazanavir (ATV) are known to have a favorable impact on lipids [5, 7, 8]. Drugs such as TDF, EFV, and ATV are becoming increasingly available in low-middle-income countries, including Asia [9, 10]. However, much of our knowledge about the relative impact of different cART regimens on lipids comes mainly from clinical trials and cohort studies from European or North-American settings [2, 4, 7, 8]. The impact of cART
Rates and Factors Associated with Major Modifications to First-Line Combination Antiretroviral Therapy: Results from the Asia-Pacific Region  [PDF]
Stephen Wright, Mark A. Boyd, Evy Yunihastuti, Matthew Law, Thira Sirisanthana, Jennifer Hoy, Sanjay Pujari, Man Po Lee, Kathy Petoumenos, on behalf of the International Epidemiologic Databases to Evaluate AIDS (IeDEA) Asia-Pacific HIV Observational Database (APHOD)
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0064902
Abstract: Background In the Asia-Pacific region many countries have adopted the WHO’s public health approach to HIV care and treatment. We performed exploratory analyses of the factors associated with first major modification to first-line combination antiretroviral therapy (ART) in resource-rich and resource-limited countries in the region. Methods We selected treatment naive HIV-positive adults from the Australian HIV Observational Database (AHOD) and the TREAT Asia HIV Observational Database (TAHOD). We dichotomised each country’s per capita income into high/upper-middle (T-H) and lower-middle/low (T-L). Survival methods stratified by income were used to explore time to first major modification of first-line ART and associated factors. We defined a treatment modification as either initiation of a new class of antiretroviral (ARV) or a substitution of two or more ARV agents from within the same ARV class. Results A total of 4250 patients had 961 major modifications to first-line ART in the first five years of therapy. The cumulative incidence (95% CI) of treatment modification was 0.48 (0.44–0.52), 0.33 (0.30–0.36) and 0.21 (0.18–0.23) for AHOD, T-H and T-L respectively. We found no strong associations between typical patient characteristic factors and rates of treatment modification. In AHOD, relative to sites that monitor twice-yearly (both CD4 and HIV RNA-VL), quarterly monitoring corresponded with a doubling of the rate of treatment modifications. In T-H, relative to sites that monitor once-yearly (both CD4 and HIV RNA-VL), monitoring twice-yearly corresponded to a 1.8 factor increase in treatment modifications. In T-L, no sites on average monitored both CD4 & HIV RNA-VL concurrently once-yearly. We found no differences in rates of modifications for once- or twice-yearly CD4 count monitoring. Conclusions Low-income countries tended to have lower rates of major modifications made to first-line ART compared to higher-income countries. In higher-income countries, an increased rate of RNA-VL monitoring was associated with increased modifications to first-line ART.
How many births in sub-Saharan Africa and South Asia will not be attended by a skilled birth attendant between 2011 and 2015?
Sonya Crowe, Martin Utley, Anthony Costello, Christina Pagel
BMC Pregnancy and Childbirth , 2012, DOI: 10.1186/1471-2393-12-4
Abstract: For each country within South Asia and sub-Saharan Africa we estimated recent trends in SBA attendance and used these as the basis for three increasingly optimistic projections for future changes in SBA attendance. For each country we obtained estimates for the current SBA attendance in rural and urban settings and forecasts for the number of births and changes in rural/urban population over 2011-2015. Based on these, we calculated estimates for the number of non-SBA births for 2011-2015 under a variety of scenarios.Conservative estimates are that there will be between 130 and 180 million non-SBA births in South Asia and sub-Saharan Africa from 2011 to 2015 (90% of these in rural areas). Currently, there are more non-SBA births per year in South Asia than sub-Saharan Africa, but our projections suggest that the regions will have approximately the same number of non-SBA births by 2015. We also present results for each of the six countries currently accounting for more than 50% of global maternal deaths.Over the next five years, many millions of women within South Asia and sub-Saharan Africa will give birth without an SBA. Efforts to improve access to skilled attendance should be accompanied by interventions to improve the safety of non-attended deliveries.Among the eight United Nations Millennium Development Goals (MDGs), progress towards the fifth, to reduce maternal mortality by three quarters between 1990 and 2015, has been particularly slow [1-4]. Although a recent global review [5] suggests levels of maternal mortality in developing regions have fallen since 1990, it has become increasingly clear that significant improvements in health care for women are required if the goal is to be achieved. This is particularly the case for sub-Saharan Africa and South Asia, in which at least 87% of the estimated annual 342,900 maternal deaths worldwide occur according to recent estimates, with over 50% of all maternal deaths occurring in only six countries (India, Nigeria, P
Potential Impact of Antiretroviral Therapy and Screening on Cervical Cancer Mortality in HIV-Positive Women in Sub-Saharan Africa: A Simulation  [PDF]
Julius Atashili,Jennifer S. Smith,Adaora A. Adimora,Joseph Eron,William C. Miller,Evan Myers
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0018527
Abstract: Despite having high cervical cancer incidence and mortality rates, screening for cervical precancerous lesions remains infrequent in sub-Saharan Africa. The need to screen HIV-positive women because of the higher prevalence and faster progression of cervical precancerous lesions may be heightened by the increased access to highly-active antiretroviral therapy (HAART). Policymakers need quantitative data on the effect of HAART and screening to better allocate limited resources. Our aim was to quantify the potential effect of these interventions on cervical cancer mortality.
Initiation of antiretroviral therapy at rural primary health care clinics in KwaZulu Natal  [cached]
Hilda Ganesen-Moothusamy,Mergan Naidoo
Health SA Gesondheid , 2013, DOI: http:// dx.doi.org/10.4102/hsag.v18i1.658
Abstract: South Africa bears the greatest burden of HIV infection globally with the most infected people living in KwaZulu-Natal (KZN). Decentralised medical care for HIV positive patients and antiretroviral therapy (ART) delivery to primary health care facilities were proposed nationally to achieve adequate ART coverage for patients in need of treatment. This study described the HIV positive patients who accessed medical care and were initiated on ART at two existing government Primary Health Care (PHC) clinics with no added donor support, in Ilembe, KZN. This was an observational descriptive study of ART initiation from 01 April 2008 to 30 April 2009. Data were collected from clinical records kept on site. HIV Testing and the pre-ART programmes which consisted of medical care prior to ART initiation are briefly described. Socio-economic, demographic and clinical characteristics of patients who were initiated on ART were sampled and described. A minority (2.95%) of the study population tested for HIV of which 36.0%tested positive. Majority (60.0%) of patients who joined the pre-ART programme care did not return. The ART sample consisted of 375 patients of whom 65.0%were women, 85.9%were unmarried, 61.6%were unemployed and 50.4%had a secondary level of education. Tuberculosis (TB) prevalence and incidence at ART initiation were 22.1%and 14.7%respectively. The prevalence of Syphilis and Hepatitis B co-infections were 13.1%and 8.6 %respectively. Two thirds of female patients (66.4%) received a Pap smear result of which the majority (62.3%) were abnormal. Uptake for HIV testing followed by relevant CD4 testing was poor. High TB, Hepatitis B and Syphilis co-infection was noted amongst patients initiated on ART. Cervical cancer screening must be intensified. Although ART initiation with no added external resources was successful, record keeping was suboptimal.
Factors Associated with Late Antiretroviral Therapy Initiation among Adults in Mozambique  [PDF]
Maria Lahuerta, Josue Lima, Harriet Nuwagaba-Biribonwoha, Mie Okamura, Maria Fernanda Alvim, Rufino Fernandes, Americo Assan, David Hoos, Batya Elul, Wafaa M. El-Sadr, Denis Nash
PLOS ONE , 2012, DOI: 10.1371/journal.pone.0037125
Abstract: Background Despite recent changes to expand the ART eligibility criteria in sub-Saharan Africa, many patients still initiate ART in the advanced stages of HIV infection, which contributes to increased early mortality rates, poor patient outcomes, and onward transmission. Methods To evaluate individual and clinic-level factors associated with late ART initiation in Mozambique, we conducted a retrospective sex-specific analysis of data from 36,411 adult patients who started ART between January 2005 and June 2009 at 25 HIV clinics in Mozambique. Late ART initiation was defined as CD4 count<100 cells/μL or WHO stage IV. Mixed effects models were used to identify patient- and clinic-level factors associated with late ART initiation. Results The proportion of patients initiating ART late decreased from 46% to 37% during 2005–2007, but remained constant (between 37–33%) from 2007–2009. Of those who initiated ART late (median CD4 = 57 cells/μL), 5% were known to have died and 54% were lost to clinic within 6 months of ART initiation (compared with 2% and 47% among other patients starting ART [median CD4 = 192 cells/μL]). In multivariate analysis, female sex and pregnancy at ART initiation (AORfemale_not_pregnant_vs._male = 0.66, 95%CI [0.62–0.69]; AORpregnant_vs._non_pregnant = 0.60, 95%CI [0.49–0.73]), younger and older age (AOR15–25_vs.26–30 = 0.86, 95%CI [0.79–0.94], AOR>45_vs.26–30 = 0.72, 95%CI [0.67–0.77]), entry into care via PMTCT (AORentry_through_PMTCT_vs.VCT = 0.42, 95%CI [0.35–0.50]), marital status (AORmarried/in union_vs.single = 0.87, 95%CI [0.83–0.92]), education (AORsecondary_or_higher_vs.primary = 0.87, 95%CI [0.83–0.93]) and year of ART initiation were associated with a lower likelihood of late ART initiation. Clinic-level factors independently associated with a lower likelihood of late ART initiation included CD4 machine on-site (AORCD4_machine_onsite_vs.offsite = 0.83, 95%CI [0.74–0.94]) and presence of PMTCT services onsite (AOR = 0.85, 95%CI [0.77–0.93]). Conclusion: The risk of starting ART late remained persistently high. Efforts are needed to ensure identification and enrollment of patients at earlier stages of HIV disease. Individual and clinic level factors identified may provide clues for upstream structural interventions.
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