Abstract:
INTRODUCTION:This descriptive, non-interventional study on HIV-1-infected patients treated with DRV/r in the usual clinical setting, with a single-arm prospective observational design, collected data on utilization of darunavir/ritonavir (DRV/r) under the conditions described in marketing authorization in usual clinical practice in Italy to evaluate efficacy and safety of DRV/r-based antiretroviral (ARV) treatment. This analysis focussed on the safety profile of DRV/r in HIV-1 infected patients. MATERIALS AND METHODS:Data were analyzed from four cohorts of HIV-1-infected patients treated with DRV/r in the real-world setting, including an ARV-naïve-DRV/r-naïve cohort (Cohort 1), an ARV-experienced-DRV/r-naïve cohort (Cohort 2) and two ARV-DRV/r-experienced cohorts (Cohorts 3 and 4), one of which (Cohort 3) was from the DRV/r Early Access Program. The objective of this analysis was to examine the safety data obtained in these four cohorts in patients enrolled from June 2009 to November 2011 and observed until December 2012 or DRV/r discontinuation. RESULTS:Safety data from 875 patients were analyzed. DRV/r-based treatment was well tolerated, with 36.2% of patients reporting ≥1 adverse event (AE) and very few discontinuations due to study drug-related AEs (3.0% overall). The most frequent AEs were diarrhoea (2.7%), reduced bone density (2.6%) and hypercholesterolaemia (2.1%) (Table 1). Regarding metabolic parameters, levels of liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST) remained stable from baseline to the last study visit (LSV) in DRV-experienced patients and decreased in DRV-naïve patients. Blood glucose concentrations remained stable in all cohorts. Serum triglyceride and cholesterol concentrations remained stable in DRV-experienced patients but increased in naïve patients, yet were still within normal range. CONCLUSIONS:In HIV-1-infected patients treated with DRV/r in these settings, the tolerability profile was favourable and similar to (or better than) that reported in controlled clinical trials. These data confirm DRV/r to be a safe treatment choice in DRV/r-experienced and naïve patients.
journal_name
J Int AIDS Socjournal_title
Journal of the International AIDS Societyauthors
Antinori A,Borderi M,Cauda R,Bini T,Chirianni A,Squillace N,Mancusi D,Termini Rdoi
10.7448/IAS.17.4.19573subject
Has Abstractpub_date
2014-11-02 00:00:00pages
19573issue
4 Suppl 3issn
1758-2652pii
19573journal_volume
17pub_type
杂志文章abstract:INTRODUCTION:Antiretroviral therapy (ART) substantially improves the health of people living with HIV and contributes to preventing new infections. While HIV incidence is decreasing in most regions, the epidemic in eastern Europe continues to rise, as new infections currently outnumber the rate of ART initiation. In th...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.1.18795
更新日期:2014-08-04 00:00:00
abstract:BACKGROUND:Traditional medication adherence measures do not account for the pharmacokinetic (PK) properties of the drugs, potentially misrepresenting true therapeutic exposure. METHODS:In a population of HIV-infected Kenyan children on antiretroviral therapy including nevirapine (NVP), we used a one-compartment model ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.20.1.21157
更新日期:2017-06-15 00:00:00
abstract:INTRODUCTION:Switching to a rilpivirine, tenofovir and emtricitabine (RTE) single-tablet regimen (STR) has been evaluated in a limited number of virologically suppressed patients. The aim of this study was to describe clinical outcomes in HIV-positive patients switched from a suppressive antiretroviral regimen to RTE S...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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abstract:INTRODUCTION:HIV testing is an essential prerequisite for accessing treatment with antiretroviral therapy or prevention using pre-exposure prophylaxis. Internet distribution of HIV self-tests is a novel approach, and data on the programmatic cost of this approach are limited. We analyse the costs and cost-effectiveness...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,随机对照试验
doi:10.1002/jia2.25445
更新日期:2020-01-01 00:00:00
abstract:INTRODUCTION:Consistent use of PrEP reduces HIV transmission from sexual practices amongst men who have sex with men (MSM) up to 92% [1]. Lisbon MSM cohort study estimates point that 59.3% of their participants at entrance (1593 HIV negative MSM enrolled between April 2011 and May 2013) were eligible for PrEP [2], acco...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19734
更新日期:2014-11-02 00:00:00
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.7448/IAS.18.7.20299
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abstract:INTRODUCTION:Transactional sex is a structural driver of HIV for women and girls in sub-Saharan Africa. In transactional relationships, sexual and economic obligations intertwine and may have positive and negative effects on women's financial standing and social status. We conducted a clinic-based survey with pregnant ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.20.1.21554
更新日期:2017-07-18 00:00:00
abstract:INTRODUCTION:The clinical value of monitoring CD4 counts in immune reconstituted, virologically suppressed HIV-infected patients is limited. We investigated if absolute lymphocyte counts (ALC) from an automated blood counting machine could accurately estimate CD4 counts. MATERIALS AND METHODS:CD4 counts, ALC and HIV v...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19680
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:Preventive therapy is essential for reducing tuberculosis (TB) burden among people living with HIV (PLWH) in high-burden settings. Short-course preventive therapy regimens, such as three-month weekly rifapentine and isoniazid (3HP) and one-month daily rifapentine and isoniazid (1HP), may help facilitate up...
journal_title:Journal of the International AIDS Society
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1186/1758-2652-14-40
更新日期:2011-08-10 00:00:00
abstract:BACKGROUND:Long-term regular clinic follow up is an important component of HIV care. We determined the frequency and characteristics of HIV-infected patients lost to follow up from a London HIV clinic, and factors associated with loss to all HIV follow up in the UK. METHODS:We identified 1859 HIV-infected adults who h...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1186/1758-2652-13-29
更新日期:2010-08-04 00:00:00
abstract:INTRODUCTION:The Good Participatory Practice (GPP): Guidelines for Biomedical HIV Prevention Trials, second edition (2011) were developed to provide clinical trial sponsors and implementers with a formal stakeholder engagement framework. As one of the largest African research institutes, Wits Reproductive Health and HI...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1002/jia2.25175
更新日期:2018-10-01 00:00:00
abstract:INTRODUCTION:HIV diagnoses among gay and bisexual men have increased over the past decade in Australia. HIV point-of-care testing (POCT) was introduced in Australia in 2011 as a strategy to increase HIV testing by making the testing process more convenient. We surveyed gay and bisexual men undergoing POCT to assess bar...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.18.1.20221
更新日期:2015-08-27 00:00:00
abstract:INTRODUCTION:The HIV Strategy in New South Wales (NSW) Australia aims to virtually eliminate HIV transmission by 2020. We estimated the 2016 HIV diagnosis and care cascade for the state of NSW, with a focus on introducing population-based data to improve data quality and assess progress towards the UNAIDS 90-90-90 targ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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更新日期:2018-04-01 00:00:00
abstract:INTRODUCTION:There are limited data characterizing the burden of HIV among men who have sex with men (MSM) in Malawi. Epidemiologic research and access to HIV prevention, treatment and care services have been traditionally limited in Malawi by criminalization and stigmatization of same-sex practices. To inform the deve...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.16.4.18742
更新日期:2013-12-02 00:00:00
abstract:INTRODUCTION:Several factors such as duration of infection, age, male gender, consumption of alcohol, HIV infection and low CD4 count have been associated with fibrosis progression rate. However, it is relatively scarce, the knowledge about the liver fibrosis progression rate in HIV-infected patients with undetectable ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19636
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:Changes in combination antiretroviral therapy (cART) throughout childhood challenge the continuity of paediatric HIV treatment. This study aimed to evaluate the prevalence of treatment interruption (TI), including lamivudine (3TC) monotherapy, and the relationship of TI to virologic and immunologic paramet...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.19.1.20936
更新日期:2016-10-27 00:00:00
abstract:INTRODUCTION:Low bone mineral density (BMD) and osteoporosis are prevalent in HIV-infected patients and were associated with HIV infection and tenofovir-containing ART. MATERIALS AND METHODS:The GUSTA study (GUided Simplification with Tropism Assay) is a two-arm, prospective, multicenter, 1:1 randomized controlled tri...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19816
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abstract:INTRODUCTION:Since 2003, US government funding to address the HIV and AIDS pandemic has been subject to an anti-prostitution clause. Simultaneously, the efficacy of some HIV prevention efforts for sex work in areas receiving US government funding has diminished. This article seeks to explain why. METHODS:This analysis...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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abstract:INTRODUCTION:Setting and monitoring progress towards targets for HIV control is critical in ensuring responsive programmes. Here, we explore how to apply targets for reduction in HIV incidence to local settings and which indicators give the strongest signal of a change in incidence in the population and are therefore m...
journal_title:Journal of the International AIDS Society
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journal_title:Journal of the International AIDS Society
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
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更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:Human immunodeficiency virus (HIV) infection is a primary cause of acquired heart disease, particularly of accelerated atherosclerosis, symptomatic heart failure, and pulmonary arterial hypertension. Cardiac complications often occur in late-stage HIV infections as prolonged viral infection is becoming mor...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.7448/IAS.16.1.18597
更新日期:2013-06-18 00:00:00
abstract:INTRODUCTION:It is estimated that over half of newly diagnosed HIV infections in Europe present late. An HIV positive individual presenting late to care represents a missed opportunity to benefit from treatment, increasing the risk of morbidity and mortality at an individual level, and onward disease transmission at po...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.17.4.19690
更新日期:2014-11-02 00:00:00
abstract:INTRODUCTION:For many women living with HIV (WLWH), the disclosure of positive status can lead to either an extension of former violence or new conflict specifically associated with HIV status disclosure. This study aims to explore the following about WLWH: 1. the women's experiences of intimate partner violence (IPV) ...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.7448/IAS.19.1.20766
更新日期:2016-03-31 00:00:00
abstract:BACKGROUND:Social constructions of masculinity have been shown to serve as an obstacle to men's access and adherence to antiretroviral therapies (ART). In the light of women's relative lack of power in many aspects of interpersonal relationships with men in many African settings, our objective is to explore how male de...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1186/1758-2652-14-29
更新日期:2011-06-09 00:00:00
abstract:INTRODUCTION:In 2016, the Global Health Sector Strategy (GHSS) on viral hepatitis called for elimination of viral hepatitis as a major public health threat by 2030 (i.e. 90% reduction in incidence and 65% in mortality). In 2017, WHO's first-ever Global Hepatitis Report presented the baseline values for each of the core...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,评审
doi:10.1002/jia2.25050
更新日期:2018-04-01 00:00:00
abstract:INTRODUCTION:Young women aged 15 to 24 years in sub-Saharan Africa continue to be disproportionately affected by HIV. A growing number of studies have suggested that the practice of transactional sex may in part explain women's heightened risk, but evidence on the association between transactional sex and HIV has not y...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章,meta分析,评审
doi:10.7448/IAS.19.1.20992
更新日期:2016-11-02 00:00:00
abstract:BACKGROUND:Injection drug use remains a major risk factor for HIV transmission in Georgia. The study aims to characterize the prevalence of HIV among injection drug users in Georgia. METHODS:A cross-sectional, anonymous bio-behavioural survey to assess knowledge and behaviour in injection drug users in combination wit...
journal_title:Journal of the International AIDS Society
pub_type: 杂志文章
doi:10.1186/1758-2652-14-9
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