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News Article | February 16, 2017

February 16, 2017-- Newly released findings from national HIV surveys in Zimbabwe, Malawi, and Zambia reveal extraordinary progress in confronting the HIV epidemic. These three countries in Southern Africa have been heavily affected by HIV, and now there are encouraging signs that the epidemics are going in the right direction. The findings, presented today at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI), are from the PEPFAR-supported Population-based HIV Impact Assessment (PHIA) Project surveys. The surveys are led by each Ministry of Health, with technical assistance from ICAP at Columbia University's Mailman School of Public Health in collaboration with the U.S. Centers for Disease Control and Prevention (CDC). Compared with previous estimates, the PHIA data show that the rate of new infections (incidence) is stabilizing or declining. In addition, more than half of all adults living with HIV, regardless of use of antiretroviral medication, have a suppressed viral load and for those on antiretroviral medication, viral suppression is close to 90 percent. "Taken together, these findings tell a coherent and remarkable story of progress," said Dr. Jessica Justman, principal investigator and associate professor of Epidemiology at the Mailman School of Public Health. "We can see that Zimbabwe, Malawi and Zambia are on track to hit the UNAIDS 90-90-90 targets by 2020." Understanding the true status of an HIV epidemic rests on accurate measures of HIV prevalence, HIV incidence, and viral load suppression. These critical estimates provide a "report card" on the control of the epidemic and indicate where resources should be channeled to enable continued progress toward the 90-90-90 targets. The PHIA Project provides such information by directly assessing all of these measures through household surveys. "These results are gratifying evidence that the investment by PEPFAR and other donors, and the efforts of national HIV programs, are paying off. The data from the PHIA surveys provide greater insights on where to focus our collective efforts and resources going forward," said Dr. Shannon Hader, director of the Division of Global HIV and Tuberculosis at CDC. In Malawi, Zambia, and Zimbabwe, nationally representative groups of adults and children were recruited in each country in 2015-16. Across the three countries, a total of 76,000 adults and children from 34,000 selected households took part in interviews and provided blood samples for testing. Participants received their HIV test result from a trained counselor during the same visit. Combined HIV prevalence across the three countries was 12.2 percent among adults ages 15-59 years and 1.4 percent among children ages 0-14 years. Combined HIV incidence among adults was 0.51 percent. The combined prevalence of viral suppression (HIV RNA "These results reflect successful HIV care and treatment programs in each country," said Dr. Wafaa El-Sadr, Director of ICAP and University Professor of Epidemiology and Dr. Mathilde Krim-amfAR Chair of Global Health at the Mailman School of Public Health. "Now more than ever, we have to keep our foot on the pedal and push even harder. Targeted testing, especially for adolescents and young adults, and continued expansion of HIV treatment programs and other prevention interventions for all will be critical to achieve ultimate epidemic control." For more information, see the PHIA Project website: The PHIA Project is a five-year, multi-country initiative funded by U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Centers for Disease Control and Prevention (CDC), and conducted by ICAP at Columbia University, CDC, and local governmental and nongovernmental partners. The PHIA Project consists of household-based, population surveys that will collect information related to HIV in 13 countries. This project is supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Centers for Disease Control and Prevention (CDC) under the terms of cooperative agreement #U2GGH001226. The contents are the responsibility of ICAP and do not necessarily reflect the views of the United States Government. ICAP was founded in 2003 at Columbia University's Mailman School of Public Health. Now a global leader in HIV and health systems strengthening, ICAP provides technical assistance and implementation support to governments and non-governmental organizations in more than 21 countries. ICAP has supported work at more than 5,300 health facilities around the world. More than 2.3 million people have received HIV care through ICAP-supported programs and over 1.3 million have begun antiretroviral therapy. Online at Founded in 1922, Columbia University's Mailman School of Public Health pursues an agenda of research, education, and service to address the critical and complex public health issues affecting New Yorkers, the nation and the world. The Mailman School is the third largest recipient of NIH grants among schools of public health. Its over 450 multi-disciplinary faculty members work in more than 100 countries around the world, addressing such issues as preventing infectious and chronic diseases, environmental health, maternal and child health, health policy, climate change & health, and public health preparedness. It is a leader in public health education with over 1,300 graduate students from more than 40 nations pursuing a variety of master's and doctoral degree programs. The Mailman School is also home to numerous world-renowned research centers including ICAP (formerly the International Center for AIDS Care and Treatment Programs) and the Center for Infection and Immunity. For more information, please visit http://www. .

Hemelaar J.,University of Oxford | Gouws E.,UNAIDS | Ghys P.D.,UNAIDS | Osmanov S.,World Health Organisation
AIDS | Year: 2011

Objective: To estimate the global and regional distribution of HIV-1 subtypes and recombinants between 2000 and 2007. Design: Country-specific HIV-1 molecular epidemiology data were combined with estimates of the number of HIV-infected people in each country. Methods: Cross-sectional HIV-1 subtyping data were collected from 65 913 samples in 109 countries between 2000 and 2007. The distribution of HIV-1 subtypes in individual countries was weighted according to the number of HIV-infected people in each country to generate estimates of regional and global HIV-1 subtype distribution for the periods 2000-2003 and 2004-2007. Results: Analysis of the global distribution of HIV-1 subtypes and recombinants in the two periods indicated a broadly stable distribution of HIV-1 subtypes worldwide with a notable increase in the proportion of circulating recombinant forms (CRFs), a decrease in unique recombinant forms (URFs) and an overall increase in recombinants. In 2004-2007, subtype C accounted for nearly half (48%) of all global infections, followed by subtypes A (12%) and B (11%), CRF02-AG (8%), CRF01-AE (5%), subtype G (5%) and D (2%). Subtypes F, H, J and K together cause fewer than 1% of infections worldwide. Other CRFs and URFs are each responsible for 4% of global infections, bringing the combined total of worldwide CRFs to 16% and all recombinants (CRFs along with URFs) to 20%. Conclusion: The global and regional distributions of individual subtypes and recombinants are broadly stable, although CRFs may play an increasing role in the HIV pandemic. The global diversity of HIV-1 poses a formidable challenge to HIV vaccine development. © 2011 Wolters Kluwer Health | Lippincott Williams & Wilkins.

News Article | February 16, 2017

BERLIN--(BUSINESS WIRE)--The biotech company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) announced today that its partner, the Danish Aarhus University Hospital, presented new data on the TEACH study at the annual Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, USA. In this study MOLOGEN’s TLR9 agonist, the Immune Surveillance Reactivator (ISR) lefitolimod, is tested in HIV-positive patients. For the first time it was shown that lefitolimod can induce a local antiviral immune response in sigmoid colon biopsies of HIV-infected patients undergoing antiretroviral treatment (ART). Lefitolimod triggered a potent response of type I interferon - a group of proteins that help regulate the activity of the immune system and is also crucial for anti-tumor responses - in the intestine, known as one major site of HIV persistence. Notably, lefitolimod did not induce unwanted inflammation. Furthermore, higher baseline TLR9 expression was associated with fewer integrated HIV-1 DNA copies. These findings strongly support the continued development of lefitolimod as an immune surveillance reactivator and represent the potential to eradicate the latent HIV reservoir. In addition, the data suggest that a similar tumor microenvironment development can be expected in the IMPALA study, a pivotal study of lefitolimod in metastatic colorectal cancer. The TEACH study started in June 2015 and has since been extended based on the broad immune system activation induced by lefitolimod. This effect was shown by the increased activation of antiviral immunity in the initial study phase. In conclusion, and consistent with the underlying hypothesis for the mode of action, lefitolimod (MGN1703) led to the activation of plasmacytoid dendritic cells (pDC), natural killer cells (NK) and T cells in HIV positive patients during antiretroviral therapy (ART). Thus, lefitolimod (MGN1703) could play a role in the “kick and kill” concept of HIV eradication. In the first phase of the trial, patients received one month of treatment. Now, in the extension phase, a group of patients receive a longer treatment of six months with lefitolimod (MGN1703). Final study results are expected to be available in mid-2017. The aim of the TEACH study is to see whether the immunotherapy with lefitolimod can activate the innate and adaptive immune system in HIV (Human Immunodeficiency Virus) positive patients to enhance killing of HIV-infected cells. TEACH (Toll-like receptor 9 enhancement of antiviral immunity in chronic HIV infection) is a non-randomized interventional phase I/IIa trial to evaluate lefitolimod (MGN1703) in HIV positive patients. In the first phase of the study, 15 participants received four weeks of lefitolimod (MGN1703) therapy (60 mg s.c. twice weekly). The extension phase includes 15 patients, too, who are treated for six months with lefitolimod. During the treatment period, each participant is closely monitored for safety and therapeutic effects of the drug. Aarhus University Hospital, Denmark is conducting the trial in two hospital centers in Denmark, for which it received funding from the American Foundation for AIDS research (amfAR). MOLOGEN is providing the Immune Surveillance Reactivator (ISR) lefitolimod (MGN1703). The primary endpoint of the first study treatment phase is the change in proportions of activated natural killer cells in patients. Secondary study endpoints include, among others, a collection of safety, virological, immunological and pharmacodynamic data. In the extension phase the change in HIV-DNA in circulating T cells will be assessed as primary endpoint. Main secondary endpoints are – besides safety evaluation – changes of functional immune parameters. HIV infects the immune system and destroys or affects the proper function of immune cells. Without antiretroviral treatment, this eventually leads to immune deficiency and the immune system can no longer fend off a wide range of infections and diseases. HIV remains a serious worldwide health issue. According to estimates by WHO and UNAIDS (United Nations Programme on AIDS) 37 million people worldwide were living with HIV at the end of 2015. Some 2 million people became newly infected in that same year, and 1.1 million died as a result of HIV-related causes globally. With new and unique technologies and active substances, the biotech company MOLOGEN is one of the pioneers in the field of immunotherapy. Alongside a focus on immuno-oncology, MOLOGEN also develops immunotherapies for the treatment of infectious diseases. The cancer immunotherapy lefitolimod (MGN1703) is the company’s lead product and best-in-class TLR9 agonist. Treatment with lefitolimod (MGN1703) triggers a broad and strong activation of the immune system. Due to this mode of action, namely to reactivate the monitoring function of the immune system, lefitolimod (MGN1703) can be recognized as an Immune Surveillance Reactivator (ISR). It has the potential to be applied to various indications. ISR lefitolimod (MGN1703) is currently being developed for first-line maintenance treatment of colorectal cancer (pivotal study) and small cell lung cancer (randomized controlled trial). Furthermore, it is also being investigated in a phase I study in HIV and a phase I combination study with the checkpoint inhibitor Yervoy® (ipilimumab), which is expected to start shortly. Next to checkpoint inhibitors, lefitolimod is one of the few product candidates that are in a phase III clinical trial (IMPALA) in the field of immuno-oncology and close to reaching the market. MOLOGEN’s pipeline focus is on new, innovative immunotherapies to treat diseases for which there is a high medical need. Biotechnologieverbund Berlin-Brandenburg (bbb) e.V. | BIO Deutschland e.V. | DECHEMA - Society for chemical technology and biotechnology e.V. | German industrial association of biotechnology (DIB) | Association for the Promotion of Science and Humanities in Germany | Association of German biotechnology companies (VBU) | Association of researching manufacturers of pharmaceuticals e.V. (VFA) | Association of the chemical industry e.V. (VCI) MOLOGEN®, dSLIM®, EnanDIM® and MIDGE® are registered trademarks of MOLOGEN AG. Certain information in this report contains forward-looking statements or the corresponding statements with negation or versions deviating from this or comparable terminology. These are described as forward-looking statements. In addition, all of the information given here that refers to planned or future results of business areas, key financial figures, developments of the financial situation or other financial figures or statistical data, is to be understood as such forward-looking statements. The company points out to investors that they should not rely on these forward-looking statements as predictions about actual future events. The company is not obligated and refuses to accept any liability for the forward-looking statements and has no obligation to update such statements in order to accurately reflect the current situation.

Buse K.,UNAIDS | Hawkes S.,University College London
Globalization and Health | Year: 2015

The Millennium Development Goals (MDGs) galvanized attention, resources and accountability on a small number of health concerns of low- and middle-income countries with unprecedented results. The international community is presently developing a set of Sustainable Development Goals as the successor framework to the MDGs. This review examines the evidence base for the current health-related proposals in relation to disease burden and the technical and political feasibility of interventions to achieve the targets. In contrast to the MDGs, the proposed health agenda aspires to be universally applicable to all countries and is appropriately broad in encompassing both communicable and non-communicable diseases as well as emerging burdens from, among other things, road traffic accidents and pollution. We argue that success in realizing the agenda requires a paradigm shift in the way we address global health to surmount five challenges: 1) ensuring leadership for intersectoral coherence and coordination on the structural (including social, economic, political and legal) drivers of health; 2) shifting the focus from treatment to prevention through locally-led, politically-smart approaches to a far broader agenda; 3) identifying effective means to tackle the commercial determinants of ill-health; 4) further integrating rights-based approaches; and 5) enhancing civic engagement and ensuring accountability. We are concerned that neither the international community nor the global health community truly appreciates the extent of the shift required to implement this health agenda which is a critical determinant of sustainable development. © 2015 Buse and Hawkes.

Larmarange J.,University of Paris Descartes | Bendaud V.,UNAIDS
AIDS | Year: 2014

Objectives: A better understanding of the subnational variations could be paramount to the efficiency and effectiveness of the response to the HIV epidemic. The purpose of this study is to describe the methodology used to produce the first estimates at second subnational level released by UNAIDS.Methods: We selected national population-based surveys with HIV testing and survey clusters geolocation, conducted in 2008 or later. A kernel density estimation approach (prevR) with adaptive bandwidths was used to generate a surface of HIV prevalence. This surface was combined with LandScan global population distribution grid to estimate the spatial distribution of people living with HIV (PLWHIV). Finally, results were adjusted to national UNAIDS's published estimates and merged per second subnational administrative unit. An indicator of the quality of the estimates was computed for each administrative unit.Results: These estimates combine two complementary approaches: The prevR method, focusing on spatial variations of HIV prevalence, as well as national estimates published by UNAIDS, taking into account trends of HIV prevalence over time. Seventeen country reports have been produced. However, quality of the estimates at second subnational level is highly heterogonous between countries, depending on the number of units and the survey sampling size. In some countries, estimates at second subnational level are very uncertain and should be interpreted with caution.Conclusion: These estimates at second subnational level constitute a first step to help countries to better understand their HIV epidemic and to inform programming at lower geographical levels. Further developments are needed to better match local needs. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.

A U.N. Program on HIV/AIDS (UNAIDS) report released ahead of World AIDS Day has it that though almost 18 million people living across the world have access to antiretroviral drugs, young and adolescent girls are at increased risk of the disease. Girls aged between 15 and 24 who are transitioning to womanhood, particularly those living in sub-Saharan Africa, are increasingly facing HIV-related challenges in their day-to-day life. On account of that, the UNAIDS has come up with a life-cycle based approach to change the scenario for good. Young women are thrice at risk of developing HIV/AIDS, said Michel Sidibé, the executive director of the Joint UNAIDS program, in a press release. In spite of elevated risk of the disease, young and adolescent girls don't have much access to HIV testing as well as exhibit poor adherence to antiretroviral treatment. Sidibé and the President of Namibia, Hage Geingob, who launched "Get on the Fast-Track: the life-cycle approach to HIV" report in Windhoek, noted that prevention is the only way to put an end to the AIDS epidemic spreading among young women. The report emphasizes the importance of breaking the cycle by which young girls acquire the deadly disease. According to data from South Africa, young and adolescent girls get infected from adult men sooner in life during their transition to womanhood. Men, however, were found to have acquired the infection much later in life and serve as a potential source of new infection cycles. Meanwhile, the report has also released encouraging statistics indicating that for the last six months — from January 2016 to June 2016 — about 1 million more people have had access to HIV treatment. According to the data recorded until June 2016, about 18.2 million people including 910,000 children were on life-saving medication. Sidibé and Geingob said that only 15 million people had access to antiretroviral medication until two years ago. The scenario has not only improved significantly but new HIV infection in children has also fallen drastically. The Fast-Track program that aims to put an end to the AIDS epidemic by 2030 should come true not only in Namibia and Africa but also throughout the world, added the duo. However, Sidibé noted that the efforts to eradicate AIDS across the world are far from over. "The progress we have made is remarkable, particularly around treatment, but it is also incredibly fragile," said Sidibé. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.

The Spectrum projection package uses estimates of national HIV incidence, demographic data and other assumptions to describe the consequences of the HIV epidemic in low and middle-income countries. The default parameters used in Spectrum are updated every 2 years as new evidence becomes available to inform the model. This paper reviews the default parameters that define the course of HIV progression among adults and children in Spectrum. For adults, data available from published and grey literature and data from the ART-LINC International epidemiologic Database to Evaluate AIDS (IeDEA) collaboration were combined to estimate survival among those who started antiretroviral therapy (ART). For children, a review of published material on survival on ART and survival on ART and cotrimoxazole was used to derive survival probabilities. Historical data on the distribution of CD4 cell counts and CD4 cell percentages by age among children who were not treated (before treatment was available) were used to progress children from seroconversion to different CD4 cell levels. Based on the updated evidence estimated survival among adults aged over 15 years in the first year on ART was 86%, while in subsequent years survival was estimated at 90%. Survival among children during the first year on ART was estimated to be 85% and for subsequent years 93%. The revised default parameters based on additional data will make Spectrum estimates more accurate than previous rounds of estimates.

The number of HIV-positive pregnant women receiving antiretroviral drugs (ARVs) to prevent mother-to-child transmission (MTCT) of HIV has increased rapidly. To estimate the reduction in new child HIV infections resulting from prevention of MTCT (PMTCT) over the past decade. To project the potential impact of implementing the new WHO PMTCT guidelines between 2010 and 2015 and consider the efforts required to virtually eliminate MTCT, defined as <5% transmission of HIV from mother to child, or 90% reduction of infections among young children by 2015. Data from 25 countries with the largest numbers of HIV-positive pregnant women were used to create five scenarios to evaluate different PMTCT interventions. A demographic model, Spectrum, was used to estimate new child HIV infections as a measure of the impact of interventions. Between 2000 and 2009 there was a 24% reduction in the estimated annual number of new child infections in the 25 countries, of which about one-third occurred in 2009 alone. If these countries implement the new WHO PMTCT recommendations between 2010 and 2015, and provide more effective ARV prophylaxis or treatment to 90% of HIV-positive pregnant women, 1 million new child infections could be averted by 2015. Reducing HIV incidence in reproductive age women, eliminating the current unmet need for family planning and limiting the duration of breastfeeding to 12 months (with ARV prophylaxis) could avert an additional 264000 infections, resulting in a total reduction of 79% of annual new child infections between 2009 and 2015, approaching but still missing the goal of virtual elimination of MTCT. To achieve virtual elimination of new child infections PMTCT programmes must achieve high coverage of more effective ARV interventions and safer infant feeding practices. In addition, a comprehensive approach including meeting unmet family planning needs and reducing new HIV infections among reproductive age women will be required.

An estimated 4.9 million adults received antiretroviral therapy (ART) in low and middle income countries in 2009. A further estimated 700000 adults received ART in high-income countries. The impact of providing ART is not often quantifiable due to limited monitoring systems. One measure, life-years gained, provides a standardised measure that shows the survival impact of ART on the population while controlling for variations in underlying survival. Measuring life-years gained allows a comparison of the impact of ART between regions. Using the Spectrum computer package, two different scenarios were created for 151 countries. One scenario describes the results of providing adults with ART as reported by countries between 1995 and 2009, the second scenario describes a situation in which no ART was provided to adults living with HIV between 1995 and 2009. The difference in the number of life-years accrued among adults in the two scenarios is compared and summarised by geographical region. An estimated 14.4 million life-years have been gained among adults globally between 1995 and 2009 as a result of ART. 54 % of these years were gained in western Europe and North America, where ART has been available for over 10 years. In recent years the growth in life-years has occurred more rapidly in sub-Saharan Africa and Asia. The substantial impact of ART described here provides evidence to argue for continued support of sustainable ART programmes in low and middle-income countries. Strengthening ART monitoring systems and mortality surveillance in low and middle-income countries will make this evidence more accessible to programme managers.

International Group on Analysis of Trends in HIV Prevalence,UNAIDS
Sexually transmitted infections | Year: 2010

In 2001 the United Nations (UN) Declaration of Commitment was signed by 189 countries with a goal to reduce HIV prevalence among young people by 25% by 2010. Progress towards this target is assessed. In addition, changes in reported sexual behaviour among young people aged 15-24 years are investigated. Thirty countries most affected by HIV were invited to participate in the study. Trends in HIV prevalence among young antenatal clinic (ANC) attendees were analysed using data from sites that were consistently included in surveillance between 2000 and 2008. Regression analysis was used to determine if the UN target had been reached. Trends in prevalence data from repeat national population-based surveys were also analysed. Trends in sexual behaviour were analysed using data from repeat standardised national population-based surveys between 1990 and 2008. Seven countries showed a statistically significant decline of 25% or more in HIV prevalence among young ANC attendees by 2008, in rural or urban areas or in both: Botswana, Côte d'Ivoire, Ethiopia, Kenya, Malawi, Namibia and Zimbabwe. Three further countries showed a significant decline in HIV prevalence among young women (Zambia) or men (South Africa, Tanzania) in national surveys. Seven other countries are on track, whereas four are unlikely to reach the goal by 2010. Nine countries did not have adequate data to assess prevalence trends. Indications suggestive of changes towards less risky sexual behaviour were observed in the majority of countries. In eight countries with significant declines in HIV prevalence, significant changes were also observed in sexual behaviour in either men or women for at least two of the three sexual behaviour indicators. Declines in HIV prevalence among young people were documented in the majority of countries with adequate data and in most cases were accompanied by changes in sexual behaviour. Further data, research and more rigorous analysis at country level are needed to understand the associations between programmatic efforts, reported behavioural changes and changes in prevalence and incidence of HIV.

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