Patient Experience and Views on Antiretroviral Treatment—Findings from the Positive Perspectives Survey

PubMed Central

Young, Benjamin; Spire, Bruno; Morcillo, Diego Garcia; Muchenje, 
Marvelous; Parkinson, Kneeshe; Krehl, Moritz; Marcotullio, Simone; Allan, Brent; Punekar, Yogesh; Namiba, Angelina; deRuiter, Annemiek; Barthel, Sophie; Koteff, Justin; Garris, Cindy; Nguyen, Christopher; Ustianowski, Andrew; Ferrer, Pedro Eitz; Murungi, Andrew

2017-01-01

overall global results. Conclusion In this international survey, the majority of PLHIV were satisfied with their current regimen, with reducing long-term adverse effects of ARVs and a longer lasting treatment identified as the most important potential improvements. Disclosures B. Young, ViiV Healthcare: Consultant and Scientific Advisor, Consulting fee and Research support; Gilead: Consultant and Scientific Advisor, Consulting fee and Research support; Merck: Consultant, Scientific Advisor and Speaker’s Bureau, Consulting fee and Research support; B. Spire, Gilead: Scientific Advisor, Consulting fee; MSD: Scientific Advisor, Consulting fee; D. Garcia Morcillo, ViiV Healthcare: Consultant, Consulting fee; K. Parkinson, ViiV Healthcare: Consultant, Consulting fee; M. Krehl, ViiV Healthcare: Consultant, Consulting fee; S. Marcotullio, Abbvie, Gilead sciences, Janssen-Cilag: Scientific Advisor, Consulting fee and Research grant; B. Allan, ViiV Healthcare: Consultant, Consulting fee; Y. Punekar, ViiV Healthcare: Employee and Shareholder, Salary; A. deRuiter, ViiV Healthcare: Employee and Shareholder, Salary; S. Barthel, GlaxoSmithKline: Employee and Shareholder, Salary; J. Koteff, ViiV Healthcare: Employee and Shareholder, Salary; C. Garris, ViiV Healthcare: Employee and Shareholder, Salary; C. Nguyen, ViiV Healthcare: Employee and Shareholder, Salary; A. Ustianowski, ViiV: Speaker’s Bureau, Conference sponsorship; Gilead: Grant Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Grant recipient and Speaker honorarium; MSD: Scientific Advisor and Speaker’s Bureau, Consulting fee and Speaker honorarium; Janssen: Scientific Advisor, Consulting fee; Abbvie: Grant Investigator, Grant recipient; P. Eitz Ferrer, ViiV Healthcare: Employee and Shareholder, Salary; A. Murungi, ViiV Healthcare: Employee, Salary

Partnerships in Pharma--An Economist Intelligence Unit Seminar--Building Innovation into Alliances and Business Models. 1 October 2010, London, UK.

PubMed

Kibble, Alexandra

2010-12-01

The Partnerships in Pharma seminar, held in London, included topics related to building innovation into alliances and business models within the pharmaceutical industry. This conference report highlights selected presentations on strategies for successful partnering, partnering alongside an evolving CRO industry, considering the pharma value chain, and partnerships between industry and academia. Approaches used by Ipsen, Merck Serono, Pfizer and ViiV Healthcare are also described.

Sisian, Zorats Karer, Tsits Karer, Karahunge ...

NASA Astrophysics Data System (ADS)

Martirosyan, Hamlet

2015-07-01

The Sisian or Zorats Karer megalithic monument is located in the RA Syunik region, 3 km away from the town of Sisian. There are holes between 4-5 cm in diamater in 85 out of 223 stones that are currently upright, each between 0.5-3 m in height. This pre-historic monument was a worship center, as well as an observatory where the Sun, planets and stars rising and setting were observed between VI-IV millennia B.C. The literal meaning of the construction's original name Sisian means "rising (stones)", and the name Zorats Karer means "stones of the stars" or "stones of the gods". The data from Mesopotamian cuneiform sources and Armenian medieval manuscripts show that the stars (constellations) were considered as personifications of certain gods. In the Zorats Karer worship center, via observations of the rising of a given star, the moment of the respective god's rising from the underground and his influence spreading over the Earth was defined.

Selected CNS Outcomes Among INSTI Antiretrovirals

PubMed Central

Wohl, David; Mills, Anthony; Mera, Robertino; Piontkowsky, David

2017-01-01

with different INSTIs. Disclosures D. Wohl, Gilead Sciences: Consultant and Investigator, Consulting fee and Research grant; Viiv: Consultant and Investigator, Consulting fee and Research grant; Janssen: Consultant, Consulting fee; Bristol-Myers Squibb: Consultant, Consulting fee; A. Mills, Gilead Sciences: Consultant, Investigator and Speaker’s Bureau, Consulting fee, Research grant and Speaker honorarium; Viiv: Consultant and Investigator, Consulting fee and Research grant; Merck: Consultant, Investigator and Speaker’s Bureau, Consulting fee, Research grant and Speaker honorarium; Janssen: Investigator, Research grant; Bristol-Myers Squibb: Investigator, Research grant; Sangamo Bio Sciences: Investigator, Research grant; R. Mera, Gilead Sciences: Employee and Shareholder, Salary; D. Piontkowsky, Gilead Sciences: Employee and Shareholder, Salary

HIV Salvage Therapy Does Not Require Nucleoside Reverse Transcriptase Inhibitors: A Randomized, Controlled Trial.

PubMed

Tashima, Karen T; Smeaton, Laura M; Fichtenbaum, Carl J; Andrade, Adriana; Eron, Joseph J; Gandhi, Rajesh T; Johnson, Victoria A; Klingman, Karin L; Ritz, Justin; Hodder, Sally; Santana, Jorge L; Wilkin, Timothy; Haubrich, Richard H

2015-12-15

Nucleoside reverse transcriptase inhibitors (NRTIs) are often included in antiretroviral regimens in treatment-experienced patients in the absence of data from randomized trials. To compare treatment success between participants who omit versus those who add NRTIs to an optimized antiretroviral regimen of 3 or more agents. Multicenter, randomized, controlled trial. (ClinicalTrials.gov: NCT00537394). Outpatient HIV clinics. Treatment-experienced patients with HIV infection and viral resistance. Open-label optimized regimens (not including NRTIs) were selected on the basis of treatment history and susceptibility testing. Participants were randomly assigned to omit or add NRTIs. The primary efficacy outcome was regimen failure through 48 weeks using a noninferiority margin of 15%. The primary safety outcome was time to initial episode of a severe sign, symptom, or laboratory abnormality before discontinuation of NRTI assignment. 360 participants were randomly assigned, and 93% completed a 48-week visit. The cumulative probability of regimen failure was 29.8% in the omit-NRTIs group versus 25.9% in the add-NRTIs group (difference, 3.2 percentage points [95% CI, -6.1 to 12.5 percentage points]). No significant between-group differences were found in the primary safety end points or the proportion of participants with HIV RNA level less than 50 copies/mL. No deaths occurred in the omit-NRTIs group compared with 7 deaths in the add-NRTIs group. Unblinded study design, and the study may not be applicable to resource-poor settings. Treatment-experienced patients with HIV infection starting a new optimized regimen can safely omit NRTIs without compromising virologic efficacy. Omitting NRTIs will reduce pill burden, cost, and toxicity in this patient population. National Institute of Allergy and Infectious Diseases, Boehringer Ingelheim, Janssen, Merck, ViiV Healthcare, Roche, and Monogram Biosciences (LabCorp).

Safety and Efficacy of Ziagen (Abacavir Sulfate) in HIV-Infected Korean Patients.

PubMed

Ann, Heawon; Kim, Ki Hyon; Choi, Hyun Young; Chang, Hyun Ha; Han, Sang Hoon; Kim, Kye Hyung; Lee, Jin Soo; Kim, Yeon Sook; Park, Kyung Hwa; Kim, Young Keun; Sohn, Jang Wook; Yun, Na Ra; Lee, Chang Seop; Choi, Young Wha; Lee, Yil Seob; Kim, Shin Woo

2017-09-01

Abacavir is a widely-used nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) infection. Mandatory postmarketing surveillance was conducted in Korea to monitor the safety and evaluate the effectiveness of Ziagen® (abacavir sulfate 300 mg; ViiV Healthcare, Middlesex, UK). An open-label, multi-center, non-interventional postmarketing surveillance study was conducted from June 2010 to June 2016 to monitor the safety and effectiveness of Ziagen across 12 hospitals in Korea. Subjects older than 18 years taking Ziagen according to prescribing information were enrolled. The primary outcome was defined as the occurrence of any adverse events after Ziagen administration. Secondary outcomes included the occurrence of adverse drug reactions, occurrence of serious adverse events, and effectiveness of Ziagen administration. A total of 669 patients were enrolled in this study, with a total observation period of 1047.8 person-years. Of these, 90.7% of patients were male. The mean age of patients was 45.8±11.9 years. One-hundred ninety-six (29.3%) patients reported 315 adverse events, and four patients reported seven serious adverse events, without any fatal events. There was one potential case of an abacavir hypersensitivity reaction. Among the 97 adverse drug reactions that were reported from 75 patients, the most frequent adverse drug reactions included diarrhea (12 events), dyspepsia (10 events), and rash (9 events). No ischemic heart disease was observed. In the effectiveness analysis, 91% of patients achieved HIV-1 RNA under 50 copies/mL after 24 months of observation with abacavir administration. Our data showed the safety and effectiveness of Ziagen in a real-world setting. During the study period, Ziagen was well-tolerated, with one incident of a clinically suspected abacavir hypersensitivity reaction. The postmarketing surveillance of Ziagen did not highlight any new safety information. These data may be helpful in

Clinically significant depressive symptoms and sexual behaviour among men who have sex with men

PubMed Central

Rodger, Alison J.; Sewell, Janey; Speakman, Andrew; Phillips, Andrew N.; Sherr, Lorraine; Gilson, Richard J.; Asboe, David; Nwokolo, Nneka C.; Clarke, Amanda; Gompels, Mark M.; Allan, Sris; Collins, Simon; Lampe, Fiona C.

2017-01-01

Background The relationship between depression and sexual behaviour among men who have sex with men (MSM) is poorly understood. Aims To investigate prevalence and correlates of depressive symptoms (Patient Health Questionnaire-9 score ≥10) and the relationship between depressive symptoms and sexual behaviour among MSM reporting recent sex. Method The Attitudes to and Understanding of Risk of Acquisition of HIV (AURAH) is a cross-sectional study of UK genitourinary medicine clinic attendees without diagnosed HIV (2013–2014). Results Among 1340 MSM, depressive symptoms (12.4%) were strongly associated with socioeconomic disadvantage and lower supportive network. Adjusted for key sociodemographic factors, depressive symptoms were associated with measures of condomless sex partners in the past 3 months (≥2 (prevalence ratio (PR) 1.42, 95% CI 1.17–1.74; P=0.001), unknown or HIV-positive status (PR 1.43, 95% CI 1.20–1.71; P<0.001)), sexually transmitted infection (STI) diagnosis (PR 1.46, 95% CI 1.19–1.79; P<0.001) and post-exposure prophylaxis use in the past year (PR 1.83, 95% CI 1.33–2.50; P<0.001). Conclusions Management of mental health may play a role in HIV and STI prevention. Declaration of interest A.N.P. has received payments for presentations made at meetings sponsored by Gilead in spring 2015. N.C.N. has received support for attendance at conferences, speaker fees and payments for attendance at advisory boards from Gilead Sciences, Viiv Healthcare, Janssen Pharmaceuticals and Bristol-Myers Squibb and a research grant from Gilead Sciences. D.A. served on the advisory board for Gilead in January 2016. M.M.G. has had sponsorship to attend conferences by Bristol-Myers Squibb, been on the BioCryst advisory board and run trials for Merck, Gilead, SSAT, BioCryst and Novartis. Copyright and usage © The Royal College of Psychiatrists 2017. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives

Strength in Amalgamation: Newer Combination Agents for HIV and Implications for Practice.

PubMed

McCoy, Christopher; Badowski, Melissa; Sherman, Elizabeth; Crutchley, Rustin; Smith, Ethan; Chastain, Daniel B

2018-01-01

Antiretroviral (ART) therapy for the treatment of human immunodeficiency virus (HIV) infection has undergone significant changes over the past 30 years. Many single-tablet regimens (STRs), including newer fixed-dose combination (FDC) tablets, are available, offering patients several options for choosing a treatment regimen that works best for them. Given these changes, patients are more likely to adhere to treatment, achieve better clinical outcomes, and experience both fewer side effects and drug-drug interactions. Newer STRs include dolutegravir (DTG)/lamivudine (3TC)/abacavir (ABC) (Triumeq; Viiv Healthcare, Research Triangle Park, NC), rilpivirine (RPV)/emtricitabine (FTC)/tenofovir alafenamide (TAF) (Odefsey; Gilead, Foster City, CA), RPV/FTC/tenofovir disoproxil fumarate (TDF) (Complera; Gilead), elvitegravir (EVG)/cobicistat (COBI)/FTC/TDF (Stribild; Gilead), and EVG/COBI/FTC/TAF (Genvoya; Gilead). Recently approved FDCs, such as atazanavir (ATV)/COBI (Evotaz; Bristol-Myers Squibb, Princeton, NJ), darunavir (DRV)/COBI (Prezcobix; Janssen Products, Titusville NJ), and FTC/TAF (Descovy; Gilead), are also now available. The Department of Health and Human Services treatment guidelines for HIV recommend many of these integrase strand transfer inhibitor (INSTI) STRs as a preferred choice for initiation of treatment in both ART-naive and -experienced patients because they offer comparably faster rates of virologic suppression, reduced rates of resistance development (especially with DTG), and overall better adherence than protease inhibitors or NNRTIs. Numerous phase 3 clinical trials support these recommendations including several switch or simplification clinical trials. Notably, the novel pharmacokinetic booster COBI, with its water soluble properties, has enabled the development and coformulation of a few of these STRs and FDCs. Also, a newer tenofovir salt formulation, TAF, has an advantageous pharmacokinetic profile, contributing to better overall renal and

Lack of effect of oral cabotegravir on the pharmacokinetics of a levonorgestrel/ethinyl oestradiol-containing oral contraceptive in healthy adult women.

PubMed

Trezza, Christine; Ford, Susan L; Gould, Elizabeth; Lou, Yu; Huang, Chuyun; Ritter, James M; Buchanan, Ann M; Spreen, William; Patel, Parul

2017-07-01

This study aimed to investigate whether cabotegravir (CAB), an integrase inhibitor in development for treatment and prevention of human immunodeficiency virus-1, influences the pharmacokinetics (PK) of a levonorgestrel (LNG) and ethinyl oestradiol (EO)-containing oral contraceptive (OC) in healthy women. In this open-label, fixed-sequence crossover study, healthy female subjects received LNG 0.15 mg/EO 0.03 mg tablet once daily Days 1-10 alone and with oral CAB 30 mg once daily Days 11-21. At the end of each treatment period, subjects underwent predose sampling for concentrations of follicle-stimulating hormone, luteinizing hormone, and progesterone and serial PK sampling for plasma LNG, EO, and CAB concentrations. Twenty women were enrolled, and 19 completed the study. One subject was withdrawn due to an adverse event unrelated to study medications. Geometric least squares mean ratios (90% confidence interval) of LNG + CAB vs. LNG alone for LNG area under the plasma concentration-time curve over the dosing interval of duration τ and maximum observed plasma concentration were 1.12 (1.07-1.18) and 1.05 (0.96-1.15), respectively. Geometric least squares mean ratio (90% confidence interval) of EO + CAB vs. EO alone for EO area under the plasma concentration-time curve over the dosing interval of duration τ and maximum observed plasma concentration were 1.02 (0.97-1.08) and 0.92 (0.83-1.03), respectively. Steady-state CAB PK parameters were comparable to historical values. There was no apparent difference in mean luteinizing hormone, follicle-stimulating hormone, and progesterone concentrations between periods. No clinically significant trends in laboratory values, vital signs, or electrocardiography values were observed. Repeat doses of oral CAB had no significant effect on LNG/EO PK or pharmacodynamics, which supports CAB coadministration with LNG/EO OCs in clinical practice. © 2017 ViiV Healthcare. British Journal of Clinical Pharmacology published by John

Dolutegravir plus abacavir-lamivudine for the treatment of HIV-1 infection.

PubMed

Walmsley, Sharon L; Antela, Antonio; Clumeck, Nathan; Duiculescu, Dan; Eberhard, Andrea; Gutiérrez, Felix; Hocqueloux, Laurent; Maggiolo, Franco; Sandkovsky, Uriel; Granier, Catherine; Pappa, Keith; Wynne, Brian; Min, Sherene; Nichols, Garrett

2013-11-07

participants in the DTG-ABC-3TC group had detectable antiviral resistance; one tenofovir DF-associated mutation and four efavirenz-associated mutations were detected in participants with virologic failure in the EFV-TDF-FTC group. Dolutegravir plus abacavir-lamivudine had a better safety profile and was more effective through 48 weeks than the regimen with efavirenz-tenofovir DF-emtricitabine. (Funded by ViiV Healthcare; SINGLE ClinicalTrials.gov number, NCT01263015 .).

Once-daily dolutegravir versus darunavir plus ritonavir in antiretroviral-naive adults with HIV-1 infection (FLAMINGO): 48 week results from the randomised open-label phase 3b study.

PubMed

Clotet, Bonaventura; Feinberg, Judith; van Lunzen, Jan; Khuong-Josses, Marie-Aude; Antinori, Andrea; Dumitru, Irina; Pokrovskiy, Vadim; Fehr, Jan; Ortiz, Roberto; Saag, Michael; Harris, Julia; Brennan, Clare; Fujiwara, Tamio; Min, Sherene

2014-06-28

reported (≥10%) adverse events were diarrhoea (dolutegravir 41 [17%] patients vs darunavir plus ritonavir 70 [29%] patients), nausea (39 [16%] vs 43 [18%]), and headache (37 [15%] vs 24 [10%]). Patients receiving dolutegravir had significantly fewer low-density lipoprotein values of grade 2 or higher (11 [2%] vs 36 [7%]; p=0·0001). Once-daily dolutegravir was superior to once-daily darunavir plus ritonavir. Once-daily dolutegravir in combination with fixed-dose NRTIs represents an effective new treatment option for HIV-1-infected, treatment-naive patients. ViiV Healthcare and Shionogi & Co. Copyright © 2014 Elsevier Ltd. All rights reserved.

Lopinavir plus nucleoside reverse-transcriptase inhibitors, lopinavir plus raltegravir, or lopinavir monotherapy for second-line treatment of HIV (EARNEST): 144-week follow-up results from a randomised controlled trial.

PubMed

Hakim, James G; Thompson, Jennifer; Kityo, Cissy; Hoppe, Anne; Kambugu, Andrew; van Oosterhout, Joep J; Lugemwa, Abbas; Siika, Abraham; Mwebaze, Raymond; Mweemba, Aggrey; Abongomera, George; Thomason, Margaret J; Easterbrook, Philippa; Mugyenyi, Peter; Walker, A Sarah; Paton, Nicholas I

2018-01-01

plus NRTI group had viral loads of less than 400 copies per mL compared with 312 (81%) of 383 in the protease inhibitor plus raltegravir group (p=0·07; lower 95% confidence limit for difference 10·2% vs specified non-inferiority margin 10%). In the protease inhibitor monotherapy group, 292 (78%) of 375 had viral loads of less than 400 copies per mL; p=0·003 versus the protease inhibitor plus NRTI group at 144 weeks. There was no difference between groups in serious adverse events, grade 3 or 4 adverse events (total or ART-related), or events that resulted in treatment modification. Protease inhibitor plus raltegravir offered no advantage over protease inhibitor plus NRTI in virological efficacy or safety. In the primary analysis, protease inhibitor plus raltegravir did not meet non-inferiority criteria. A regimen of protease inhibitor with NRTIs remains the best standardised second-line regimen for use in programmes in resource-limited settings. European and Developing Countries Clinical Trials Partnership (EDCTP), UK Medical Research Council, Instituto de Salud Carlos III, Irish Aid, Swedish International Development Cooperation Agency, Instituto Superiore di Sanita, Merck, ViiV Healthcare, WHO. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Trends in underlying causes of death in people with HIV from 1999 to 2011 (D:A:D): a multicohort collaboration.

PubMed

Smith, Colette J; Ryom, Lene; Weber, Rainer; Morlat, Philippe; Pradier, Christian; Reiss, Peter; Kowalska, Justyna D; de Wit, Stephane; Law, Matthew; el Sadr, Wafaa; Kirk, Ole; Friis-Moller, Nina; Monforte, Antonella d'Arminio; Phillips, Andrew N; Sabin, Caroline A; Lundgren, Jens D

2014-07-19

disease (0.33 [0.20-0.53) death rates still decreased over time. The percentage of all deaths that were AIDS-related (87/256 [34%] in 1999-2000 and 141/627 [22%] in 2009-11) and liver-related (40/256 [16%] in 1999-2000 and 64/627 [10%] in 2009-11) decreased over time, whereas non-AIDS cancers increased (24/256 [9%] in 1999-2000 to 142/627 [23%] in 2009-11). Recent reductions in rates of AIDS-related deaths are linked with continued improvement in CD4 cell count. We hypothesise that the substantially reduced rates of liver disease and cardiovascular disease deaths over time could be explained by improved use of non-HIV-specific preventive interventions. Non-AIDS cancer is now the leading non-AIDS cause and without any evidence of improvement. Oversight Committee for the Evaluation of Metabolic Complications of HAART, with representatives from academia, patient community, US Food and Drug Administration, European Medicines Agency and consortium of AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, ViiV Healthcare, Merck, Pfizer, F Hoffmann-La Roche, and Janssen Pharmaceuticals. Copyright © 2014 Elsevier Ltd. All rights reserved.