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Amedeo F Capetti, Gaetana Sterrantino, Maria Vittoria Cossu, GianCarlo Orofino, Giorgio Barbarini, Giuseppe V De Socio, Simona Di Giambenedetto, Antonio Di Biagio, Benedetto M Celesia, Barbara Argenteri, Giuliano Rizzardini
INTRODUCTION: Little information is available on the efficacy and safety of the dual combination of ripivirine plus dolutegravir. This work aims at beginning to fill this gap. METHODS: All HIV-1 infected subjects treated with ripivirine plus dolutegravir between October 2014 and September 2015 in eight Italian centres were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48. RESULTS: One hundred and thirty-two subjects were followed for a median of 24 months, mean 33 months...
2016: PloS One
Eva Heger, Alexandra Theis, Klaus Remmel, Hauke Walter, Alejandro Pironti, Elena Knops, Veronica Di Cristanziano, Björn Jensen, Stefan Esser, Rolf Kaiser, Nadine Lübke
Phenotypic resistance analysis is an indispensable method for determination of HIV-1 resistance and cross-resistance to novel drug compounds. Since integrase inhibitors are essential components of recent antiretroviral combination therapies, phenotypic resistance data, in conjunction with the corresponding genotypes, are needed for improving rules-based and data-driven tools for resistance prediction, such as HIV-Grade and geno2pheno[integrase]. For generation of phenotypic resistance data to recent integrase inhibitors, a recombinant phenotypic integrase susceptibility assay was established...
October 10, 2016: Journal of Virological Methods
Aastha Gupta, Sandeep Juneja, Marco Vitoria, Vincent Habiyambere, Boniface Dongmo Nguimfack, Meg Doherty, Daniel Low-Beer
With anti-retroviral treatment (ART) scale-up set to continue over the next few years it is of key importance that manufacturers and planners in low- and middle-income countries (LMICs) hardest hit by the HIV/AIDS pandemic are able to anticipate and respond to future changes to treatment regimens, generics pipeline and demand, in order to secure continued access to all ARV medicines required. We did a forecast analysis, using secondary WHO and UNAIDS data sources, to estimate the number of people living with HIV (PLHIV) and the market share and demand for a range of new and existing ARV drugs in LMICs up to 2025...
2016: PloS One
George W Rutherford, Hacsi Horvath
BACKGROUND: Dolutegravir (DTG) is a once-daily unboosted second-generation integrase-inhibitor that along with two nucleoside reverse transcriptase inhibitors is one of several regimens recommended by the United States, United Kingdom and European Union for first-line antiretroviral treatment of people with HIV infection. Our objective was to review the evidence for the efficacy and safety of DTG-based first-line regimens compared to efavirenz (EFV)-based regimens. METHODS: We conducted a systematic review...
2016: PloS One
F Raffi, S Esser, G Nunnari, I Pérez-Valero, L Waters
In an era when most individuals with treated HIV infection can expect to live into old age, clinicians should proactively review their patients' current and future treatment needs and challenges. Clinical guidelines acknowledge that, in the setting of virological suppression, treatment switch may yield benefits in terms of tolerability, regimen simplification, adherence, convenience and long-term health considerations, particularly in the context of ageing. In this paper, we review evidence from six key clinical studies on switching virologically suppressed patients to regimens based on integrase strand transfer inhibitors (INSTIs), the antiretroviral class increasingly preferred as initial therapy in clinical guidelines...
October 2016: HIV Medicine
Matt S Anderson, Sauzanne Khalilieh, Ka Lai Yee, Rachael Liu, Li Fan, Matthew L Rizk, Vedangi Shah, Azra Hussaini, Ivy Song, Lisa L Ross, Joan R Butterton
INTRODUCTION: Doravirine, a non-nucleoside reverse-transcriptase inhibitor in development for the treatment of patients with human immunodeficiency virus-1 infection, has potential to be used concomitantly in antiretroviral therapy with dolutegravir, an integrase strand transfer inhibitor. The pharmacokinetic interactions between these drugs were therefore assessed. METHODS: Oral formulations of doravirine and dolutegravir were dosed both individually and concomitantly once daily in healthy adults...
October 4, 2016: Clinical Pharmacokinetics
Janani Varadarajan, Mary Jane McWilliams, Bryan T Mott, Craig J Thomas, Steven J Smith, Stephen H Hughes
BACKGROUND: HIV-1 integrase is the target for three FDA-approved drugs, raltegravir, elvitegravir, and dolutegravir. All three drugs bind at the active site of integrase and block the strand transfer step of integration. We previously showed that sub-optimal doses of the anti-HIV drug raltegravir can cause aberrant HIV integrations that are accompanied by a variety of deletions, duplications, insertions and inversions of the adjacent host sequences. RESULTS: We show here that a second drug, elvitegravir, also causes similar aberrant integrations...
September 29, 2016: Retrovirology
Mark de Boer, Guido van den Berk, Natasja van Holten, Josephine Oryszczyn, Willemien Dorama, Daoud Ait Moha, Kees Brinkman
OBJECTIVE: Dolutegravir (DGV) is one of the preferred antiretroviral agents in first line cART. Though considered a well-tolerated drug, we aimed to determine the actual rate, timing, and detailed motivation of stopping DGV in a real life clinical setting. DESIGN: a cohort study including all patients that started DGV in two HIV treatment centers in the Netherlands. METHODS: All cART-naïve and cART-experienced patients who had started DGV were identified from the institutional HIV-databases...
September 24, 2016: AIDS
Amedeo F Capetti, Giancarlo Orofino, Gaetana Sterrantino, Maria V Cossu, Giovanni Cenderello, Anna M Cattelan, Giuseppe V De Socio, Stefano Rusconi, Niccolò Riccardi, Gian M Baldin, Serena Cima, Fosca P Niero, Giuliano Rizzardini, Lolita Sasset
BACKGROUND: Dolutegravir plus darunavir provide high genetic barrier to HIV-1 resistance and fit for simple salvage regimens. METHODS: All HIV-1 infected subjects treated with dolutegravir plus boosted darunavir dual therapy between March 2011 and September 2015 were included in an observational cohort. Data were collected at baseline and at weeks 4, 12, 24 and 48. RESULTS: We enrolled 113 subjects. After week 24 one was lost at follow-up, one dropped out for grade 2 elevation of liver enzimes, one died from illicit drug abuse and one from cancer-related sepsis...
September 23, 2016: Antiviral Therapy
Steve Kanters, Marco Vitoria, Meg Doherty, Maria Eugenia Socias, Nathan Ford, Jamie I Forrest, Evan Popoff, Nick Bansback, Sabin Nsanzimana, Kristian Thorlund, Edward J Mills
BACKGROUND: New antiretroviral therapy (ART) regimens for HIV could improve clinical outcomes for patients. To inform global guidelines, we aimed to assess the comparative effectiveness of recommended ART regimens for HIV in ART-naive patients. METHODS: For this systematic review and network meta-analysis, we searched for randomised clinical trials published up to July 5, 2015, comparing recommended antiretroviral regimens in treatment-naive adults and adolescents (aged 12 years or older) with HIV...
September 6, 2016: Lancet HIV
Manuel Tsiang, Gregg S Jones, Joshua Goldsmith, Andrew Mulato, Derek Hansen, Elaine Kan, Luong Tsai, Rujuta A Bam, George Stepan, Kirsten M Stray, Anita Niedziela-Majka, Stephen R Yant, Helen Yu, George Kukolj, Tomas Cihlar, Scott Lazerwith, Kirsten L White, Haolun Jin
Bictegravir (BIC; GS-9883), a novel potent, once-daily, unboosted inhibitor of HIV-1 integrase (IN) specifically targets IN strand transfer activity (IC50 = 7.5 ± 0.3 nM) and HIV-1 integration in cells. BIC exhibits potent and selective in vitro antiretroviral activity in both T-cell lines and primary human T-lymphocytes with EC50 values ranging from 1.5 to 2.4 nM and selectivity indices up to 8800 relative to cytotoxicity. BIC exhibits synergistic in vitro antiviral effects in pairwise combinations with tenofovir alafenamide, emtricitabine or darunavir and maintains potent antiviral activity against HIV-1 variants resistant to other classes of antiretrovirals...
September 19, 2016: Antimicrobial Agents and Chemotherapy
Zhang Dawei, He Hongqiu, Liu Mengmeng, Meng Zhixia, Guo Shunxing
HIV-1 integrase (IN) plays an essential role in viral replication and thus serves as an important target for chemotherapeutic intervention against HIV-1 infection. However, the current three clinical IN inhibitors, raltegravir, elvitegravir and dolutegravir share the same inhibitory mechanism, resulting in a common clinical resistance profile which have emerged in infected patients receiving treatment. Therefore, it is important to develop small molecule inhibitors that impair IN function with distinct mechanisms of action...
2016: Scientific Reports
J Ambrosioni, D Nicolás, C Manzardo, F Agüero, J L Blanco, M M Mosquera, J Peñafiel, J M Gatell, M A Marcos, J M Miró
OBJECTIVES: The most recent guidelines suggest using integrase strand-transfer inhibitors (InSTIs) as the preferred antiretroviral regimens for naive HIV-infected individuals. However, resistance to InSTIs is not monitored in many centres at baseline. This study aimed to evaluate the prevalence of InSTI resistance substitutions in newly diagnosed patients with acute/recent HIV infection. METHODS: Genotypic drug resistance tests were performed in all consecutive patients prospectively enrolled with a documented infection of <6 months, from 12 May 2015 to 12 May 2016...
September 13, 2016: Journal of Antimicrobial Chemotherapy
Junjun Jiang, Xi Xu, Wenqin Guo, Jinming Su, Jiegang Huang, Bingyu Liang, Hui Chen, Ning Zang, Yanyan Liao, Li Ye, Hao Liang
BACKGROUND: The first-generation integrase inhibitors (INIs) raltegravir (RAL) and elvitegravir (EVG) have shown efficacy against HIV infection, but they have the limitations of once-more daily dosing and extensive cross-resistance. Dolutegravir (DTG, S/GSK1349572), a second-generation drug that overcomes such shortcomings, is under spotlight. The purpose of this study is to review the evidence for DTG use in clinical settings, including its efficacy and safety. METHODS: PubMed, EMbase, Ovid, Web of Science, Science Direct, and related websites were screened from establishment until July 2013, and scientific meeting proceedings were manually searched...
2016: AIDS Research and Therapy
Laura Comi, Franco Maggiolo
INTRODUCTION: Since the last revision of both European and American guidelines (EACS and DHHS), new data from clinical trials and cohort studies, as well as experience in clinical practice, have prompted significant changes to the list of recommended/preferred options for the treatment of HIV infected patients, highlighted the role of INSTI-based regimens. Dolutegravir (DTG) in combination with abacavir/lamivudine (ABC/3TC) is one of these preferred regimens in multiple clinical scenarios, including treatment-naive and treatment-experienced patients...
October 2016: Expert Opinion on Pharmacotherapy
Celia Oldenbuettel, Eva Wolf, Ayla Ritter, Sebastian Noe, Silke Heldwein, Rita Pascucci, Carmen Wiese, Ariane Von Krosigk, Eva Jaegel-Guedes, Hans Jaeger, Annamaria Balogh, Christine Koegl, Christoph D Spinner
BACKGROUND: The potential toxicity of long-term antiretroviral treatment (ART) requires ongoing investigation of novel strategies for treatment of HIV-infected patients. Monotherapy with the integrase inhibitor (INSTI) dolutegravir (DTG) may offer a favorable safety profile. Additionally, DTG has a high barrier of resistance, crucial for successful maintenance of virologic control. However, published data is sparse. METHODS: Retrospective, single-center cohort study...
September 2, 2016: Antiviral Therapy
Arkaitz Imaz, Javier Martinez-Picado, Jordi Niubó, Angela D M Kashuba, Elena Ferrer, Dan Ouchi, Craig Sykes, Nerea Rozas, Laura Acerete, Jordi Curto, Antonia Vila, Daniel Podzamczer
OBJECTIVE:  To quantify HIV-1 RNA decay and dolutegravir (DTG) concentrations in semen of HIV-infected patients on DTG-based first-line therapy. METHODS:  Prospective, single-arm, open-label study including 15 HIV-1 infected, ART-naïve men initiating DTG (50 mg)+abacavir/lamivudine (600/300 mg) once daily. HIV-1 RNA was measured in seminal (SP) and blood plasma (BP) at baseline, days 3, 7, 14, weeks 4, 12 and 24. HIV-1 RNA decay rate was assessed using nonlinear mixed-effects models...
August 30, 2016: Journal of Infectious Diseases
Matteo Vassallo, Anne De Monte, Jacques Durant, Brigitte Dunais, Jacqueline Cottalorda
No abstract text is available yet for this article.
September 10, 2016: AIDS
Jiangzhou You, Hongren Wang, Xiaojun Huang, Zhen Qin, Zhaomin Deng, Jun Luo, Baoning Wang, Mingyuan Li
BACKGROUND: Integrase strand transfer inhibitors (INSTIs) are a novel class of anti-HIV agents that show high activity in inhibiting HIV-1 replication. Currently, licensed INSTIs include raltegravir (RAL), elvitegravir (EVG) and dolutegravir (DTG); these drugs have played a critical role in AIDS therapy, serving as additional weapons in the arsenal for treating patients infected with HIV-1. To date, long-term data regarding clinical experience with INSTI use and the emergence of resistance remain scarce...
2016: PloS One
Sej Todd, C R Emerson
We report this case to highlight the possibility of a severe hypersensitivity reaction as an important potential consequence of couples, living with HIV, sharing anti-retroviral treatment. An HIV-1 positive and carrier of HLA-B*57:01 allele, treatment experienced man was commenced one pill Regimen Stribild (tenofovir, emtricitabine, elvitegravir and cobicistat) in July 2015. On running short of medication, he admitted to sharing his partner's treatment (Triumeq; abacavir, lamivudine and dolutegravir). On the second occasion, re-introduction resulted in whole body rash 4 h post dose and was associated with fever, respiratory symptoms, headache and vomiting...
August 16, 2016: International Journal of STD & AIDS
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