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Linda Aurpibul, Sirinya Teerananchai, Wasana Prasitsuebsai, Tavitiya Sudjaritruk, Pope Kosalaraksa, Nia Kurniati, Khanh Huu Truong, Viet Chau Do, Lam Van Nguyen, Kulkanya Chokephaibulkit, Thida Singtoroj, Stephen J Kerr
BACKGROUND: Failure rates of second-line boosted protease inhibitor antiretroviral therapy regimens in children rise over time. Therapeutic drug monitoring (TDM) can contribute to assessments of adherence. The authors assessed the performance characteristics of the US DHHS-recommended lopinavir (LPV) concentration of 1.0 mg/L for predicting virologic failure (VF) and intermediate-to-high level LPV resistance in Asian children. MATERIALS AND METHODS: LPV concentration, HIV RNA level, and adherence data from study participants in Indonesia, Thailand, and Vietnam receiving second-line LPV-based ART and followed for ≥24 weeks were analyzed...
August 1, 2016: Therapeutic Drug Monitoring
Mitch M Matoga, Mina C Hosseinipour, Evgenia Aga, Heather J Ribaudo, Nagalingeswaran Kumarasamy, John Bartlett, Michael D Hughes
BACKGROUND: Cardiovascular disease (CVD) is an emerging concern for HIV-infected patients. Hyperlipidemia is a risk factor for CVD and a complication of protease-inhibitor-based antiretroviral therapy, but little is known about its incidence and risk factors in treated patients in resource-limited settings (RLS). METHODS: We conducted a secondary analysis of ACTG A5230 trial in which HIV-infected adults from India, Malawi, Tanzania, Thailand and South Africa, with virologic relapse on first line therapy were initiated on lopinavir/ritonavir (LPV/r) monotherapy...
October 14, 2016: Antiviral Therapy
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
Paul Randell, Akil Jackson, Ana Milinkovic, Marta Boffito, Graeme Moyle
BACKGROUND: We aimed to measure the effect of raltegravir (RAL) on insulin sensitivity and surrogates of CV risk in healthy HIV-seronegative volunteers compared to that of lopinavir/r (LPV/r), a positive control. METHODS: An open label, two phase crossover study in HIV-negative male subjects randomized 1:1 to receive either 2 weeks of LPV/r followed by a two week washout period and two weeks of RAL, or RAL initially followed by LPV/r. A hyperinsulinaemic euglycaemic clamp was performed prior to and following each 2-week dosing phase...
October 6, 2016: Antiviral Therapy
Amandine Cournil, Arsène Hema, Sabrina Eymard-Duvernay, Laura Ciaffi, Stéphanie Badiou, Firmin N Kabore, Assane Diouf, Liliane Ayangma, Vincent Le Moing, Jacques Reynes, Sinata Koulla-Shiro, Eric Delaporte
BACKGROUND: To investigate change in renal function in African patients initiating second line ART including ritonavir-boosted protease inhibitor (PI/r) with or without tenofovir disoproxil fumarate (TDF). METHODS: HIV-1 positive adults, failing standard first line ART were randomized to either TDF/FTC+LPV/r; ABC+ddI+LPV/r or TDF/FTC+DRV/r and followed until 18 months. Patients with an estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1,73m(2) at baseline were included in this analysis...
October 5, 2016: Antiviral Therapy
Saran Vardhanabhuti, David Katzenstein, John Bartlett, Nagalingeswaran Kumarasamy, Carole L Wallis
Background.  The mechanism of virologic failure (VF) of lopinavir/ritonavir (LPV/r) monotherapy is not well understood. We assessed sequence changes in human immunodeficiency virus-1 reverse-transcriptase (RT) and protease (PR) regions. Methods.  Human immunodeficiency virus-1 pol sequences from 34 participants who failed second-line LPV/r monotherapy were obtained at study entry (SE) and VF. Sequence changes were evaluated using phylogenetic analysis and hamming distance. Results.  Human immunodeficiency virus-1 sequence change was higher over drug resistance mutation (DRM) sites (median genetic distance, 2...
September 2016: Open Forum Infectious Diseases
Grishma M Patel, Pragna K Shelat, Anita N Lalwani
Aim of present work was to apply Quality by Design (QbD) principles for the development of proliposome of poorly soluble lopinavir (LPV). The patient-centric quality target product profile (QTPP) was defined and critical quality attributes (CQAs) earmarked. Risk assessment studies were carried out to identify the probable risks affecting the CQAs of the product. On the basis of preliminary study, lipid: drug ratio and amount of carrier were selected as critical material attributes (CMAs) and were optimized by face centered central composite design...
August 29, 2016: European Journal of Pharmaceutical Sciences
Setha Limsreng, Olivier Marcy, Sowath Ly, Vara Ouk, Hak Chanroeurn, Saem Thavary, Ban Boroath, Ana Canestri, Gérald Viretto, Jean-François Delfraissy, Olivier Ségéral
BACKGROUND: Lopinavir/ritonavir (LPV/r) is widely used in Cambodia with high efficacy but scarce data exist on long-term metabolic toxicity. METHODS: We carried out a cross-sectional and retrospective study evaluating metabolic disorders and cardiovascular risk in Cambodian patients on LPV/r-based antiretroviral therapy (ART) for > 1 year followed in Calmette Hospital, Phnom Penh. Data collected included cardiovascular risk factors, fasting blood lipids and glucose, and retrospective collection of bioclinical data...
2016: PloS One
Nicola Gianotti, Laura Galli, Renato Maserati, Laura Sighinolfi, Diego Ripamonti, Loredana Palvarini, Sergio Lo Caputo, Emanuele Focà, Benedetto Maurizio Celesia, Franco Baldelli, Gaetana Sterrantino, Adriano Lazzarin
In a multicentre, open-label, clinical trial, 43 patients virologically suppressed while receiving a standard triple antiretroviral therapy were randomized (1:1:1) to switch to monotherapy with darunavir/ritonavir (DRV/r-MT arm), monotherapy with lopinavir/ritonavir (LPV/r-MT arm) or to continue on the ongoing regimen (cART arm). The proportion (95% CI) of patients with virological success (Snapshot analysis) at week 48 was 73% (48%-90%) in the DRV/r-MT arm, 69% (42%-88%) in the LPV/r-MT arm and 87% (61%-98%) in the cART arm...
August 23, 2016: New Microbiologica
Megan L Falsetta, David C Foster, Collynn F Woeller, Stephen J Pollock, Adrienne D Bonham, Constantine G Haidaris, Richard P Phipps
: Chronic vulvar pain is alarmingly common in women of reproductive age and is often accompanied by psychological distress, sexual dysfunction, and a significant reduction in quality of life. Localized provoked vulvodynia (LPV) is associated with intense vulvar pain concentrated in the vulvar vestibule (area surrounding vaginal opening). To date, the origins of vulvodynia are poorly understood, and treatment for LPV manages pain symptoms, but does not resolve the root causes of disease...
August 17, 2016: Journal of Pain: Official Journal of the American Pain Society
Abhirup Mandal, Dhananjay Pal, Ashim K Mitra
PURPOSE: This study was aimed to develop a novel Histidine-Leucine-Lopinavir (His-Leu-LPV) dipeptide prodrug and evaluate its potential for circumvention of P-gp and MRP2-mediated efflux of lopinavir (LPV) indicated for HIV-1 infection. METHODS: His-Leu-LPV was synthesized following esterification of hydroxyl group of LPV and was identified by (1)H NMR and LCMS/MS techniques. Aqueous solubility, stability and cell cytotoxicity of prodrug was determined. Uptake and permeability studies were carried out using P-gp (MDCK-MDR1) and MRP2 (MDCK-MRP2) transfected cell lines...
October 15, 2016: International Journal of Pharmaceutics
Peiqi Zhou, Zhikai Gan, Xu Huang, Chunlian Mei, Meizhen Huang, Yuxing Xia, Hui Wang
Owing to the innate stabilization of built-in potential in p-n junction or metal-oxide-semiconductor structure, the sensitivity and linearity of most lateral photovoltaic effect (LPE) devices is always fixed after fabrication. Here we report a nonvolatile and tunable switching effect of lateral photo-voltage (LPV) in Cu dusted ultrathin metal-oxide-semiconductor structure. With the stimulation of electric pulse and local illumination, the sensitivity and linearity of LPV can be adjusted up and down in a nonvolatile manner...
2016: Scientific Reports
Alessandra Latini, Massimiliano Fabbiani, Vanni Borghi, Gaetana Sterrantino, Alberto Giannetti, Patrizia Lorenzini, Laura Loiacono, Adriana Ammassari, Rita Bellagamba, Manuela Colafigli, Gabriella D'Ettorre, Simona Di Giambenedetto, Andrea Antinori, Mauro Zaccarelli
BACKGROUND: Aim of the study was to assess predictors of discontinuation/toxicity of boosted PI-based (PI/r) dual therapy (DT). METHODS: Observational, retrospective switch study in patients successfully treated with triple drugs regimen. Patients switched to PI/r based DT [darunavir (DRV/r), lopinavir (LPV/r) or atazanavir (ATV/r)] plus a second drug: [raltegravir (RAL), maraviroc (MVC) etravirine (ETR), lamivudine (3TC) or tenofovir (TDF)] between 2009 and 2014 were included...
2016: BMC Infectious Diseases
Antonio Rivero, José Antonio Pérez-Molina, Antonio Javier Blasco, José Ramón Arribas, Manuel Crespo, Pere Domingo, Vicente Estrada, José Antonio Iribarren, Hernando Knobel, Pablo Lázaro, José López-Aldeguer, Fernando Lozano, Santiago Moreno, Rosario Palacios, Juan Antonio Pineda, Federico Pulido, Rafael Rubio, Javier de la Torre, Montserrat Tuset, Josep M Gatell
INTRODUCTION: GESIDA and the AIDS National Plan panel of experts suggest preferred (PR), alternative (AR), and other regimens (OR) for antiretroviral treatment (ART) as initial therapy in HIV-infected patients for the year 2016. The objective of this study is to evaluate the costs and the efficacy of initiating treatment with these regimens. METHODS: Economic assessment of costs and efficiency (cost/efficacy) based on decision tree analyses. Efficacy was defined as the probability of reporting a viral load <50copies/mL at week 48 in an intention-to-treat analysis...
July 23, 2016: Enfermedades Infecciosas y Microbiología Clínica
Linda Barlow-Mosha, Konstantia Angelidou, Jane Lindsey, Moherndran Archary, Mark Cotton, Sylvia Dittmer, Lee Fairlie, Enid Kabugho, Portia Kamthunzi, Arti Kinikar, Tapiwa Mbengeranwa, Levina Msuya, Pauline Sambo, Kunjal Patel, Emily Barr, Patrick Jean-Phillipe, Avy Violari, Lynne Mofenson, Paul Palumbo, Benjamin H Chi
BACKGROUND: The International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) P1060 study demonstrated short-term superiority of lopinavir/ritonavir (LPV/r) over nevirapine (NVP) in antiretroviral therapy (ART), regardless of prior NVP exposure. However, NVP-based ART had a marginal benefit in CD4 percentage (CD4%) and growth. We compared 5-year outcomes from this clinical trial. METHODS: Human immunodeficiency virus (HIV)-infected, ART-eligible children were enrolled into 2 cohorts based on prior NVP exposure and randomized to NVP- or LPV/r-based ART...
October 15, 2016: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
Stephen M Arpadi, Stephanie Shiau, Renate Strehlau, Faeezah Patel, Ndileka Mbete, Donald J McMahon, Jonathan J Kaufman, Ashraf Coovadia, Louise Kuhn, Michael T Yin
BACKGROUND: We investigate if switching from a ritonavir-boosted lopinavir (LPV/r)-based to an efavirenz-based antiretroviral therapy (ART) regimen is associated with beneficial bone development. METHODS: The CHANGES Bone Study follows HIV-infected children who participated in a non-inferiority randomized trial in Johannesburg, South Africa evaluating the safety and efficacy of pre-emptive switching to efavirenz (N[REPLACEMENT CHARACTER]=[REPLACEMENT CHARACTER]106) compared to remaining on LPV/r (N[REPLACEMENT CHARACTER]=[REPLACEMENT CHARACTER]113)...
July 16, 2016: AIDS
Xu-Ying Luo, Ying-Hong Hu, Xiang-Yuan Cao, Yan Kang, Li-Ping Liu, Shou-Hong Wang, Rong-Guo Yu, Xiang-You Yu, Xia Zhang, Bao-Shan Li, Zeng-Xiang Ma, Yi-Bing Weng, Heng Zhang, De-Chang Chen, Wei Chen, Wen-Jin Chen, Xiu-Mei Chen, Bin Du, Mei-Li Duan, Jin Hu, Yun-Feng Huang, Gui-Jun Jia, Li-Hong Li, Yu-Min Liang, Bing-Yu Qin, Xian-Dong Wang, Jian Xiong, Li-Mei Yan, Zheng-Ping Yang, Chen-Ming Dong, Dong-Xin Wang, Qing-Yuan Zhan, Shuang-Lin Fu, Lin Zhao, Qi-Bing Huang, Ying-Guang Xie, Xiao-Bo Huang, Guo-Bin Zhang, Wang-Bin Xu, Yuan Xu, Ya-Ling Liu, He-Ling Zhao, Rong-Qing Sun, Ming Sun, Qing-Hong Cheng, Xin Qu, Xiao-Feng Yang, Ming Xu, Zhong-Hua Shi, Han Chen, Xuan He, Yan-Lin Yang, Guang-Qiang Chen, Xiu-Mei Sun, Jian-Xin Zhou
BACKGROUND: Over the years, the mechanical ventilation (MV) strategy has changed worldwide. The aim of the present study was to describe the ventilation practices, particularly lung-protective ventilation (LPV), among brain-injured patients in China. METHODS: This study was a multicenter, 1-day, cross-sectional study in 47 Intensive Care Units (ICUs) across China. Mechanically ventilated patients (18 years and older) with brain injury in a participating ICU during the time of the study, including traumatic brain injury, stroke, postoperation with intracranial tumor, hypoxic-ischemic encephalopathy, intracranial infection, and idiopathic epilepsy, were enrolled...
July 20, 2016: Chinese Medical Journal
Yongyou Wu, Guangqiang Chen, Pengfei Wu, Jianbin Zhu, Wei Peng, Chungen Xing
BACKGROUND: Precise determination and classification of left gastric vein (LGV) anatomy are helpful in planning for gastric surgery, in particular, for resection of gastric cancer. However, the anatomy of LGV is highly variable. A systematic classification of its variations is still to be proposed. We aimed to investigate the anatomical variations in LGV using CT imaging and develop a new nomenclature system. METHOD: We reviewed CT images and tracked the course of LGV in 825 adults...
July 8, 2016: Surgical and Radiologic Anatomy: SRA
Wasana Prasitsuebsai, Sirinya Teeraananchai, Thida Singtoroj, Khanh Huu Truong, Jintanat Ananworanich, Viet Chau Do, Lam Van Nguyen, Pope Kosalaraksa, Nia Kurniati, Tavitiya Sudjaritruk, Kulkanya Chokephaibulkit, Stephen J Kerr, Annette H Sohn
BACKGROUND: Data on pediatric treatment outcomes and drug resistance while on second-line antiretroviral therapy (ART) are needed to guide HIV care in resource-limited countries. METHODS: HIV-infected children <18 years who were switched or switching to second-line ART after first-line failure were enrolled from 8 sites in Indonesia, Thailand, and Vietnam. Genotyping was performed at virologic failure (VF; HIV-RNA >1000 copies/mL). Cox proportional hazards regression was used to evaluate factors predicting VF...
August 1, 2016: Journal of Acquired Immune Deficiency Syndromes: JAIDS
Antonella d'Arminio Monforte, Alessandro Cozzi-Lepri, Franco Maggiolo, Giuliano Rizzardini, Paolo Emilio Manconi, Nicola Gianotti, Tiziana Quirino, Carmela Pinnetti, Stefano Rusconi, Andrea De Luca, Andrea Antinori
BACKGROUND: There are no data comparing the response to PI/r-based regimens in people presenting for care with low CD4 counts or AIDS (LC). AIM: To compare the response to LPV/r-, DRV/r- or ATV/r-based cART regimens in LC initiating cART from ART-naive. METHODS: We included people enrolled in Icona with either CD4 counts ≤350 cells/mm3 (low CD4-LC) or CD4 counts ≤200 cells/mm3 (very low CD4-VLC) and/or AIDS, starting their first PI/r-based regimen after 2008...
2016: PloS One
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