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Human immunodeficiency virus (HIV)‐positive women can breastfeed with minimal risk of mother‐to‐child transmission if taking antiretrovirals. Guidelines surrounding infant feeding for HIV‐positive women have evolved several times over the last two decades. Our review aimed to explore perspectives of breastfeeding with antiretrovirals from HIV‐positive women since the World Health Organization (2010) infant feeding and antiretroviral guidelines. HIV‐positive pregnant and postnatal women from all countries/settings were eligible. HIV‐positive women were either on an antiretroviral regimen at the time of the study, previously on an antiretroviral regimen, not initiated on a regimen yet, or enrolled in prevention of mother‐to‐child transmission (PMTCT) care. Quality assessment of all included studies were conducted. Four databases (CINAHL, EMBASE, MEDLINE and PsycINFO) were searched for studies conducted from January 2010 to October 2020. Nine papers were included in the review, of which two presented findings from the same study. Five analytical themes were developed via thematic synthesis: (1) awareness of breastfeeding with antiretrovirals, (2) turmoil of emotions, (3) coping mechanisms, (4) the intertwining of secret, stigma and support and (5) support needed. Support from family and health care professionals and coping approaches were important to overcome stigma and the emotional challenges of breastfeeding with antiretrovirals. Health care professionals should be familiar with the most updated national and local guidance surrounding infant feeding and antiretrovirals. Further research into interventions to encourage HIV‐positive women to adhere and commit to lifelong antiretroviral treatment (Option B+) for breastfeeding is required. [ABSTRACT FROM AUTHOR]

Introduction: In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. Discussion: USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. Conclusions: In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example. [ABSTRACT FROM AUTHOR]

Introduction The extraordinary feat of proving the effectiveness of oral pre-exposure prophylaxis (PrEP) in clinical trials in different populations in a variety of settings may prove to have been easier than ensuring it is used well. Decision-makers must make difficult choices to realize the promise of antiretroviral prophylaxis for their countries. This paper outlines key economic, regulatory and distributive justice issues that must be addressed for effective and acceptable PrEP implementation. Discussion In considering the role that PrEP can play in combination prevention programmes, decision-makers must determine who can benefit most from PrEP, how PrEP can be provided safely and efficiently, and what kind of health system support will ensure successful implementation. To do this, they need contextualized information on disease burden by population, analyses of how PrEP services might best be delivered, and projections of the human resource and infrastructure requirements for each potential delivery model. There are cost considerations, varying cost-effectiveness results and regulatory challenges. The principles of ethics can inform thorny discussions about who should be prioritized for oral PrEP and how best to introduce it fairly. We describe the cost-effectiveness of PrEP in different populations at higher risk of HIV exposure, its price in low- and middle-income countries, and the current regulatory situation. We explore the principles of ethics that can inform resource allocation decision-making about PrEP anchored in distributive justice, at a time when universal access to antiretroviral treatment remains to be assured. We then highlight the role of advocacy in moving the PrEP agenda forward. Conclusions The time is ripe now for decisions about whether, how and for whom PrEP should be introduced into a country's HIV response. It has the potential to contribute significantly to high impact HIV prevention if it is tailored to those who can most benefit from it and if current regulatory and pricing barriers can be overcome. Advocacy at all levels can help inform decision-making and push the access agenda to avert HIV infections among those at highest risk of HIV exposure. The benefits will accrue beyond the individual level to slow HIV transmission at the population level. [ABSTRACT FROM AUTHOR]

The article discusses research which examined the role of pre-exposure prophylaxis (PrEP) in addressing the global HIV/AIDS epidemic. Topics discussed include the papers on the PrEP implementation, potential impact and efficiency, social science concerns and the study of modern PrEP implementation and cost-effectiveness analysis targeting PrEP and antiretroviral (ART).

Background: Patients with human immunodeficiency virus (HIV) are at a significantly higher risk of cardiovascular disease (CVD) compared to HIV‐negative people. Left heart dysfunction is the most common cardiac complication in people living with HIV/acquired immune deficiency syndrome (PLWHA), and diastolic dysfunction is an important predictor of cardiovascular events. The aims of this study were (1) to detect changes in left cardiac structure and function in antiretroviral therapy (ART)‐naive PLWHA using echocardiography; and (2) to investigate the risk factors for the development of left ventricular diastolic dysfunction (LVDD) in ART‐naive PLWHA. Methods: We retrospectively included 105 ART‐naïve PLWHA and included 90 healthy subjects as controls to compare the differences in left heart structure and function between the two groups. Univariate and multifactorial logistic regression were employed to explore the risk factors of the development of LVDD in ART‐naive PLWHA. Results: The left ventricular end‐diastolic internal diameter (LVEDD), left ventricular mass index (LVMI), and left atrial volume index (LAVI) were significantly greater in PLWHA than in controls (p <.05). The E/A ratio, lateral e′ velocity, and mitral deceleration time were significantly lower in PLWHA than in controls (p <.05). Average E/e′ ratio was significantly higher in PLWHA than in controls (p <.05). Left ventricular ejection fraction (LVEF) and left ventricular fractional shortening (LVFS) were not significantly different between PLWHA and controls (p >.05). Multifactorial logistic regression analysis showed that age, body mass index (BMI), and CD4+ count <200 cells/μL were independent risk factors for LVDD in ART‐naive PLWHA (OR = 1.781, 1.228, 3.683, p <.05). Conclusions: Left ventricular systolic function did not differ between PLWHA and controls, and left ventricular diastolic function was lower in PLWHA than in controls. Age, BMI, and CD4+ count were independent factors affecting LVDD in ART‐naive PLWHA. [ABSTRACT FROM AUTHOR]

The retinoid (10mM) increased viral reactivation mediated by IL-15 to a similar extent as HODHBt (100mM) but unlike HODHBt, specifically promoted cell death of latently infected cells compared to controls when combined with IL-15. This indicates that the retinoid is able to reactivate latent HIV through a mechanism mediated by IL-15 but not directly dependent on STAT5 phosphorylation. Among the clinically relevant latency reversing agents (LRA) under investigation, IL-15 or the IL-15 superagonist N-803 have been shown to reactivate latent HIV I ex vivo i and I in vivo i . [Extracted from the article]

Acquired immune deficiency syndrome is an epidemic infectious disease which is caused by the human immunodeficiency virus (HIV) and that has proliferated across worldwide. It has been a matter of concern for the scientific community to develop an antiretroviral therapy, which will prompt a rapid decline in viral abundance. With this motivation, this study proposes the design of a robust super twisting sliding mode controller based on output information for an uncertain HIV infection model. The control objective is to decrease the concentration of infected CD4+ T cells to a specified level by drug administration using only the output information of the uncertain HIV infection model which is total CD4+ T cell concentration. The robust output-feedback controller has been developed in combination with a robust exact differentiator, functioning as an observer. The reported analysis demonstrates that the approach proposed here is capable of ensuring robust performance under several operating conditions, measurement and modelling error, parametric uncertainties and external disturbances and the simulation results prove the proficiency of the controller proposed. [ABSTRACT FROM AUTHOR]

Introduction: Successful population-level antiretroviral therapy (ART) adherence will be necessary to realize both the clinical and prevention benefits of antiretroviral scale-up and, ultimately, the end of AIDS. Although many people living with HIV are adhering well, others struggle and most are likely to experience challenges in adherence that may threaten virologic suppression at some point during lifelong therapy. Despite the importance of ART adherence, supportive interventions have generally not been implemented at scale. The objective of this review is to summarize the recommendations of clinical, research, and public health experts for scalable ART adherence interventions in resource-limited settings. Methods: In July 2015, the Bill and Melinda Gates Foundation convened a meeting to discuss the most promising ART adherence interventions for use at scale in resource-limited settings. This article summarizes that discussion with recent updates. It is not a systematic review, but rather provides practical considerations for programme implementation based on evidence from individual studies, systematic reviews, meta-analyses, and the World Health Organization Consolidated Guidelines for HIV, which include evidence from randomized controlled trials in low- and middle-income countries. Interventions are categorized broadly as education and counselling; information and communication technology-enhanced solutions; healthcare delivery restructuring; and economic incentives and social protection interventions. Each category is discussed, including descriptions of interventions, current evidence for effectiveness, and what appears promising for the near future. Approaches to intervention implementation and impact assessment are then described. Results and discussion: The evidence base is promising for currently available, effective, and scalable ART adherence interventions for resource-limited settings. Numerous interventions build on existing health care infrastructure and leverage available resources. Those most widely studied and implemented to date involve peer counselling, adherence clubs, and short message service (SMS). Many additional interventions could have an important impact on ART adherence with further development, including standardized counselling through multi-media technology, electronic dose monitoring, decentralized and differentiated models of care, and livelihood interventions. Optimal targeting and tailoring of interventions will require improved adherence measurement. Conclusions: The opportunity exists today to address and resolve many of the challenges to effective ART adherence, so that they do not limit the potential of ART to help bring about the end of AIDS. [ABSTRACT FROM AUTHOR]

Introduction: Specific environmental factors may play a role in the development of Pneumocystis pneumonia (PCP) in HIVpositive patients. The aim of this study was to estimate the PCP incidence and mortality in hospitalized HIV-positive patients in Spain during the combination antiretroviral therapy (cART) era (1997 to 2011), as well as to analyze the climatological factors and air pollution levels in relation to hospital admissions and deaths. Methods: We carried out a retrospective study. Data were collected from the National Hospital Discharge Database and the State Meteorological Agency of Spain. A case-crossover analysis was applied to identify environmental risk factors related to hospitalizations and deaths. For each patient, climatic factors and pollution levels were assigned based on readings from the nearest meteorological station to his or her postal code. Results: There were 13,139 new PCP diagnoses and 1754 deaths in hospitalized HIV-positive patients from 1997 to 2011. The PCP incidence (events per 1000 person-years) dropped from 11.6 in 1997 to 2000, to 5.4 in 2004 to 2011 (p<0.001). The mortality (events per 10,000 person-years) also decreased from 14.3 in 1997 to 2000, to 7.5 in 2004 to 2011 (p<0.001). Most hospital admissions and deaths occurred in the winter season and the fewest occurred in the summer, overlapping respectively with the lowest and highest temperatures of the year in Spain. Moreover, lower temperatures prior to PCP admission, as well as higher concentrations of NO2 and particulate matter up to 10 m in size (PM10) at the time of admission were associated with higher likelihoods of hospital admission due to PCP when two weeks, one month, 1.5 months or two months were used as controls (p<0.01). Furthermore, higher concentrations of ozone at one month (p=0.007), 1.5 months (p<0.001) and two months (p=0.006) prior to admission were associated with higher likelihoods of hospital admission with PCP. For PCP-related deaths, lower temperatures prior to admission and higher concentrations of atmospheric PM10 at the time of admission were related to higher likelihood of death when two weeks, one month and 1.5 months were used as controls (p<0.05). Conclusions: PCP was a significant health problem in the cART era (1997 to 2011), and PCP epidemiology was adversely influenced by colder climatological factors and higher ambient air pollution levels. [ABSTRACT FROM AUTHOR]