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      Magnitude and predictors of first-line antiretroviral therapy regimen change among HIV infected adults: A retrospective cross sectional study

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          Abstract

          Background

          Regimen change remains a significant challenge towards the achievement of human immunodeficiency virus (HIV) treatment success. In developing countries where limited treatment options are available, strategies are required to ensure the sustainability and durability of the starting regimens. Nevertheless, information regarding the rate and predictors of regimen change is limited in these settings.

          Objective

          This study was undertaken to determine the prevalence and predictors of changes in ART regimens among patients initiating highly active antiretroviral therapy (HAART) at XX.

          Materials and methods

          An institutional based retrospective cross-sectional study was conducted among adult naïve HIV patients who had initiated HAART at XX between 2010. Data were extracted by reviewing their medical charts using a pretested structured check-list. The Kaplan–Meier survival analyses were used to describe the probability of ARV regimen changes while Cox proportional hazard regression models were employed to identify the predictors of ARV regimen modifications. Data were analyzed using SPSS version 21 software, and statistical significant was deemed at p < 0.05.

          Results

          A total of 770 patients were enrolled in this study of these 165 (21.43%) had their ART regimen modified at least once. Drug toxicity was the main reason for regimen change followed by TB comorbidity, and treatment failure. Positive baseline TB symptoms (aHR = 1.63, p = 0.037), and Zidovudine based regimen (aHR = 1.76, p = 0.011) as compared to Stavudine based regimen were at higher risk of ART modification. Conversely, urban residence, baseline World Health organization (WHO) stage 2 as compared to WHO stage 1, baseline CD4 count ≥301 as compared to CD4 count ≤200 were at lower risk of ART modification.

          Conclusion

          The rate of initial HAART regimen change was found to be high. Thus, less toxic and better tolerated HIV treatment options should be available and used more frequently. Moreover, early detection and initiation of ART by the government is highly demanded to maximize the benefit and reduce risk of ART modifications.

          Highlights

          • The majorities (57.4%) of the patients were female and the mean age of the study participants was 32.9 ± 9.5

          • A total of 165 (21.4%) participants experienced antiretroviral regimen changes within two years of follow-up period.

          • The highest rate of treatment modification was found among patients receiving fixed-dose combination of AZT+3 TC + NVP 81 (49.0%).

          • Drug toxicity was the main reason for ARV regimen change, which accounts for 74 (41.3%) of regimen change.

          • Anemia was the main forms of toxicities which accounted for 45(36.3%).

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          Most cited references35

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          STROCSS 2021: Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery

          Introduction Strengthening The Reporting Of Cohort Studies in Surgery (STROCSS) guidelines were developed in 2017 in order to improve the reporting quality of observational studies in surgery and updated in 2019. In order to maintain relevance and continue upholding good reporting quality among observational studies in surgery, we aimed to update STROCSS 2019 guidelines. Methods A STROCSS 2021 steering group was formed to come up with proposals to update STROCSS 2019 guidelines. An expert panel of researchers assessed these proposals and judged whether they should become part of STROCSS 2021 guidelines or not, through a Delphi consensus exercise. Results 42 people (89%) completed the DELPHI survey and hence participated in the development of STROCSS 2021 guidelines. All items received a score between 7 and 9 by greater than 70% of the participants, indicating a high level of agreement among the DELPHI group members with the proposed changes to all the items. Conclusion We present updated STROCSS 2021 guidelines to ensure ongoing good reporting quality among observational studies in surgery. • In order to maintain relevance and continue upholding good reporting quality among observational studies in surgery, STROCSS 2019 guidelines were updated through a DELPHI consensus exercise. • 42 people participated in the development of STROCSS 2021 guidelines and there was a high level of agreement among the DELPHI group members with the proposed changes to all the items. • Updated STROCSS 2021 guideline is presented.
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            Estimates of global, regional, and national incidence, prevalence, and mortality of HIV, 1980–2015: the Global Burden of Disease Study 2015

            Summary Background Timely assessment of the burden of HIV/AIDS is essential for policy setting and programme evaluation. In this report from the Global Burden of Disease Study 2015 (GBD 2015), we provide national estimates of levels and trends of HIV/AIDS incidence, prevalence, coverage of antiretroviral therapy (ART), and mortality for 195 countries and territories from 1980 to 2015. Methods For countries without high-quality vital registration data, we estimated prevalence and incidence with data from antenatal care clinics and population-based seroprevalence surveys, and with assumptions by age and sex on initial CD4 distribution at infection, CD4 progression rates (probability of progression from higher to lower CD4 cell-count category), on and off antiretroviral therapy (ART) mortality, and mortality from all other causes. Our estimation strategy links the GBD 2015 assessment of all-cause mortality and estimation of incidence and prevalence so that for each draw from the uncertainty distribution all assumptions used in each step are internally consistent. We estimated incidence, prevalence, and death with GBD versions of the Estimation and Projection Package (EPP) and Spectrum software originally developed by the Joint United Nations Programme on HIV/AIDS (UNAIDS). We used an open-source version of EPP and recoded Spectrum for speed, and used updated assumptions from systematic reviews of the literature and GBD demographic data. For countries with high-quality vital registration data, we developed the cohort incidence bias adjustment model to estimate HIV incidence and prevalence largely from the number of deaths caused by HIV recorded in cause-of-death statistics. We corrected these statistics for garbage coding and HIV misclassification. Findings Global HIV incidence reached its peak in 1997, at 3·3 million new infections (95% uncertainty interval [UI] 3·1–3·4 million). Annual incidence has stayed relatively constant at about 2·6 million per year (range 2·5–2·8 million) since 2005, after a period of fast decline between 1997 and 2005. The number of people living with HIV/AIDS has been steadily increasing and reached 38·8 million (95% UI 37·6–40·4 million) in 2015. At the same time, HIV/AIDS mortality has been declining at a steady pace, from a peak of 1·8 million deaths (95% UI 1·7–1·9 million) in 2005, to 1·2 million deaths (1·1–1·3 million) in 2015. We recorded substantial heterogeneity in the levels and trends of HIV/AIDS across countries. Although many countries have experienced decreases in HIV/AIDS mortality and in annual new infections, other countries have had slowdowns or increases in rates of change in annual new infections. Interpretation Scale-up of ART and prevention of mother-to-child transmission has been one of the great successes of global health in the past two decades. However, in the past decade, progress in reducing new infections has been slow, development assistance for health devoted to HIV has stagnated, and resources for health in low-income countries have grown slowly. Achievement of the new ambitious goals for HIV enshrined in Sustainable Development Goal 3 and the 90-90-90 UNAIDS targets will be challenging, and will need continued efforts from governments and international agencies in the next 15 years to end AIDS by 2030. Funding Bill & Melinda Gates Foundation, and National Institute of Mental Health and National Institute on Aging, National Institutes of Health.
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              The UNAIDS 90–90–90 target: a clear choice for ending AIDS and for sustainable health and development

              The roadmap for ending the AIDS epidemic is clear. Combined with a stronger focus on HIV prevention, reaching the 90–90–90 target – by 2020, 90% of all people living with HIV know their HIV status, 90% of people with diagnosed HIV receive antiretroviral therapy (ART) and 90% of all people on HIV treatment achieve viral suppression – will enable us to lay the groundwork to end the AIDS epidemic by 2030 [1]. Scaled-up ART is a pillar of effective HIV prevention, as experience in different parts of the world has demonstrated that expanding the use of ART is directly correlated with declines in new HIV infections [2,3]. When the 90–90–90 target was first formulated and recommended by the UNAIDS Scientific and Technical Advisory Committee, it was met with scepticism in some quarters. However, since the launch of the 90–90–90 target in 2014, programmatic results have confirmed that the target, while ambitious, is achievable. In Malawi, a low-income country, implementation of a test-and-treat approach among pregnant women living with HIV has proven so successful that it is now seen as a stepping-stone towards universal treatment access and achievement of the 90–90–90 target [4]. Botswana, a middle-income country, is already well on its way towards the 90–90–90 benchmarks and will likely reach or exceed them before 2020 [5], and a large programme that provides ART to nearly 1000 people in community settings in Kenya and Uganda (lower middle- and low-income countries, respectively) has generated comparable results [6]. High-income countries, many of which have lagged in treatment outcomes, are also seeing improved treatment outcomes; in the United States, the proportion of people living with HIV who know their HIV status now approaches 90% [7], and the proportion of people receiving ART who are virally suppressed in the United States has risen from 72% in 2009 to 80% in 2013 [8]. Despite these promising signs, there is cause for concern, as critical steps needed to achieve 90–90–90 have yet to be taken, and key decision-makers and stakeholders have yet to display the sense of urgency needed to seize this historic opportunity to end the epidemic. Taking advantage of this unique opportunity to end the AIDS epidemic demands that we confront and overcome these obstacles. As of 2 December 2015, only 12 countries and a large province of another country had formally adopted the World Health Organization's recommendation to initiate ART in all people living with HIV, regardless of CD4 count [9]. Although a number of additional countries have more recently adopted the recommended test-and-treat approach to ART and others are poised to do so in the coming months, the pace at which international guidance is being taken up in countries remains far too slow. Reaching the 90–90–90 target will require roughly doubling over the next five years the number of people receiving ART. However, health systems are weak and overstretched in many countries, underscoring the need for innovative approaches to strengthen health systems. Training and empowering community health workers to assume many ART-related tasks and to bring services closer to the people who need them are an urgent necessity. UNAIDS recommends that the share of HIV-related clinical services provided in community settings must rise from 5% currently to 30% to make the achievement of 90–90–90 feasible [1]. One key gap in current treatment scale-up efforts is the failure in too many cases to reach marginalized populations, including men who have sex with men, migrants, people who inject drugs, prisoners, sex workers and transgender people [10]. In addition to implementing focused outreach and service strategies for these populations, it is also essential to remove punitive laws, policies and practices that violate human rights, increase people's vulnerability to and risk of acquiring HIV and impede utilization of services, including travel restrictions and those that block key populations’ access to services [11]. Potential threats are also emerging regarding the future availability of optimally affordable antiretroviral (ARV) medicines. Four Indian manufacturers account for roughly 70% of the ARV market in low- and middle-income countries [12]. Although local and regional manufacture of pharmaceuticals may be a longer term solution to the healthcare challenges faced by Africa and other regions, maintaining the engagement of generic producers and research and development industry will be vital for achieving the 90–90–90 target by 2020. This is especially so, given that several promising ARV products that are well advanced in the pipeline have the potential, when manufactured as generic products, to save as much as US$ 3 billion on HIV treatment costs over 10 years [13]. However, the preservation of the generic ARV market is potentially threatened by international efforts to impose, through bilateral and multilateral trade agreements, patent rules that exceed those required under international intellectual property law [14]. As a problem with a global reach and impact, AIDS demands global approaches to end this epidemic. While governments have a legitimate interest in promoting free trade and supporting their domestic industries, they must not do so in a way that imperils the ability of low- and middle-income countries to address important health needs. In the push to achieve 90–90–90, the availability of essential funding is also a cause for concern. Especially worrisome is the flattening of international HIV assistance [15], which jump-started HIV treatment scale-up 15 years ago. Although domestic spending has stepped in to finance HIV treatment services in many countries, governments in other countries have yet to allocate sufficient domestic resources. The engagement of international donors will remain critical, especially in low-income, high-burden countries that lack the capacity to fully self-finance universal HIV treatment. At the same time that efforts are redoubled to mobilize new resources, complementary efforts will be required to improve efficiency and optimize the use of available resources. Analyses indicate that steps to maximize the efficiency of ARV procurement and HIV service delivery could help limit the costs of treatment programmes [12]. One of the targets in the sustainable development goals (SDGs), endorsed by the United Nations (UN) Member States at the 2015 UN Sustainable Development Summit, is to end the AIDS epidemic by 2030. However, the SDGs reflect a substantial broadening of the international development agenda, with ending AIDS representing only one of 169 targets. Maintaining a focus on AIDS in such a complex and crowded development agenda will be challenging. Yet, it is critical that decision-makers recognize the stakes involved in the 90–90–90 target. Following through and ending the AIDS epidemic as a public health threat will yield profound and long-lasting benefits in the form of improved productivity, averted future treatment costs and enhanced outcomes for children [1]. By the same token, a failure to build further on the achievements of the AIDS response will erase the gains made to date, allow the epidemic to rebound and vastly increase the human and financial costs associated with AIDS in future years [1]. In short, investing to end the AIDS epidemic will not only ensure that the world achieves the AIDS-specific SDG target, but also advance progress across the broad Agenda for Sustainable Development, positioning countries and their peoples to thrive in future decades. Our “choice,” in other words, is really no choice at all. We must act now to fully leverage the preventive and therapeutic benefits of ART to lay the groundwork to end AIDS once and for all.
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                Author and article information

                Contributors
                Journal
                Ann Med Surg (Lond)
                Ann Med Surg (Lond)
                Annals of Medicine and Surgery
                Elsevier
                2049-0801
                17 August 2022
                September 2022
                17 August 2022
                : 81
                : 104303
                Affiliations
                [a ]Department of Pharmacy, College of Medicine and Health Sciences, Adigrat University, Ethiopia
                [b ]Department of Clinical Pharmacy, School of Pharmacy, College of Health Sciences, Mekelle University, Ethiopia
                [c ]Department of Pharmacy, College of Medicine and Health Sciences, Bahir Dar University, Ethiopia
                [d ]Department of Anesthesiology, College of Medicine and Health Sciences, Dilla University, Ethiopia
                [e ]Department of Anesthesiology, College of Medicine and Health Sciences, Debrebirhan University, Ethiopia
                [f ]Department of Anesthesiology, College of Medicine and Health Sciences, Mekelle University, Ethiopia
                Author notes
                []Corresponding author aberet2005@ 123456gmail.com
                Article
                S2049-0801(22)01063-9 104303
                10.1016/j.amsu.2022.104303
                9486446
                36147157
                bf87f71e-100c-4598-829a-6aad3c30a2cb
                © 2022 Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd.

                This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

                History
                : 6 June 2022
                : 25 July 2022
                : 26 July 2022
                Categories
                Cross-sectional Study

                prevalence,reasons,haart change,adult hiv patients,predictors,ethiopia

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