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1. Maraviroc Pharmacokinetics in HIV-1–Infected Pregnant Women

Author

Colbers, Angela, Best, Brookie, Schalkwijk, Stein, Wang, Jiajia, Stek, Alice, Tenorio, Carmen Hidalgo, Hawkins, David, Taylor, Graham, Kreitchmann, Regis, Burchett, Sandra, Haberl, Annette, Kabeya, Kabamba, van Kasteren, Marjo, Smith, Elizabeth, Capparelli, Edmund, Burger, David, Mirochnick, Mark, Team, for the PANNA Network and the IMPAACT 1026 Study, van der Ende, ME, Erasmus, MC, van der Ven, AJAM, Nellen, J, Moltó, J, Nicastri, E, Giaquinto, C, Gingelmaier, A, Lyons, F, Lambert, J, Wyen, C, Faetkenheuer, G, Rockstroh, JK, Schwarze-Zander, C, Sadiq, S Tariq, Gilleece, Y, Wood, C, Buschur, Shelley, Jackson, Chivon, Paul, Mary, Florez, Claudia, Bryan, Patricia, Stone, Monica, Katz, Mindy, Auguste, Raphaelle, Wiznia, Andrew, Bruder, Karen L, Lewis, Gail, Casey, Denise, Losso, Marcelo H, Ivalo, Silvina A, Hakim, Alejandro, Deveikis, Audra, Batra, Jagmohan, Alvarez, Janielle Jackson, Knapp, Katherine M, Sublette, Nina, Wride, Thomas, Febo, Irma L, Santos, Ruth, and Tamayo, Vivian

Subjects
Medical Microbiology, Reproductive Medicine, Biomedical and Clinical Sciences, HIV/AIDS, Infectious Diseases, Clinical Research, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Reproductive health and childbirth, Infection, Adult, Anti-HIV Agents, Blood Chemical Analysis, Cyclohexanes, Europe, Female, HIV Infections, Humans, Maraviroc, Pregnancy, Pregnancy Complications, Infectious, Triazoles, United States, Young Adult, MTCT, pharmacokinetics, pregnancy, HIV, maraviroc, PANNA Network and the IMPAACT 1026 Study Team, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

ObjectiveTo describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)-infected women during pregnancy and post partum.MethodsHIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery. Cord blood samples and matching maternal blood samples were taken at delivery. The data were collected in 2 studies: P1026 (United States) and PANNA (Europe). Pharmacokinetic parameters were calculated.ResultsEighteen women were included in the analysis. Most women (12; 67%) received 150 mg of maraviroc twice daily with a protease inhibitor, 2 (11%) received 300 mg twice daily without a protease inhibitor, and 4 (22%) had an alternative regimen. The geometric mean ratios for third-trimester versus postpartum maraviroc were 0.72 (90% confidence interval, .60-.88) for the area under the curve over a dosing interval (AUCtau) and 0.70 (0.58-0.85) for the maximum maraviroc concentration. Only 1 patient showed a trough concentration (Ctrough) below the suggested target of 50 ng/mL, both during pregnancy and post partum. The median ratio of maraviroc cord blood to maternal blood was 0.33 (range, 0.03-0.56). The viral load close to delivery was

Published
2015

3. Incidence of dyslipidemia in people with HIV who are treated with integrase inhibitors versus other antiretroviral agents

Author

Byonanebye D. M., Polizzotto M. N., Begovac J., Grabmeier-Pfistershammer K., Abela I., Castagna A., de Wit S., Mussini C., Vehreschild J. J., d'Arminio Monforte A., Wit F. W. N. M., Pradier C., Chkhartishvili N., Sonnerborg A., Hoy J., Lundgren J., Neesgaard B., Bansi-Matharu L., Greenberg L., Llibre J. M., Vannappagari V., Gallant J., Necsoi C., Cichon P., Reiss P., Aho I., Tsertsvadze T., Mennozzi M., Rauch A., Muccini C., Law M., Mocroft A., Ryom L., Petoumenos K., Hillebregt M., Rose N., Zangerle R., Appoyer H., Delforge M., Wandeler G., Stephan C., Bucht M., Chokoshvili O., Rodano A., Tavelli A., Fanti I., Borghi V., Fontas E., Dollet K., Caissotti C., Casabona J., Miro J. M., Smith C., Lampe F., Johnson M., Burns F., Chaloner C., Lazzarin A., Poli A., Falconer K., Svedhem V., Gunthard H., Ledergerber B., Bucher H., Scherrer A., Wasmuth J. C., Rockstroh J., Fatkenheuer G., Stecher M., Schulze N., Franke B., Rooney J., Rogatto F., Garges H., Kowalska J., Raben D., Peters L., Anne A. V., Dedes N., Williams E. D., Bruguera A., Haubrich R., Svedhem-Johansson V., Bloch M., Braun D., Calmy A., Schuttfort G., Youle M., Zona S., Antinori A., Bolokadze N., Schwarze-Zander C., Duvivier C., Dragovic G., Radoi R., Oprea C., Vasylyev M., Matulionyte R., Mulabdic V., Marchetti G., Kuzovatova E., Coppola N., Martini S., Harxhi A., Waehre T., Pharris A., Vassilenko A., Bogner J., Maagaard A., Jablonowska E., Elbirt D., Marrone G., Leen C., Wyen C., Kundro M., Thorpe D., Volny-Anne A., Mendao L., Larsen J. F., Jakobsen M. L., Bruun T., Bojesen A., Hansen E. V., Elsing T. W., Kristensen D., Thomsen S., Weide T., Pelchen-Matthews A., Byonanebye, D. M., Polizzotto, M. N., Begovac, J., Grabmeier-Pfistershammer, K., Abela, I., Castagna, A., de Wit, S., Mussini, C., Vehreschild, J. J., d'Arminio Monforte, A., Wit, F. W. N. M., Pradier, C., Chkhartishvili, N., Sonnerborg, A., Hoy, J., Lundgren, J., Neesgaard, B., Bansi-Matharu, L., Greenberg, L., Llibre, J. M., Vannappagari, V., Gallant, J., Necsoi, C., Cichon, P., Reiss, P., Aho, I., Tsertsvadze, T., Mennozzi, M., Rauch, A., Muccini, C., Law, M., Mocroft, A., Ryom, L., Petoumenos, K., Hillebregt, M., Rose, N., Zangerle, R., Appoyer, H., Delforge, M., Wandeler, G., Stephan, C., Bucht, M., Chokoshvili, O., Rodano, A., Tavelli, A., Fanti, I., Borghi, V., Fontas, E., Dollet, K., Caissotti, C., Casabona, J., Miro, J. M., Smith, C., Lampe, F., Johnson, M., Burns, F., Chaloner, C., Lazzarin, A., Poli, A., Falconer, K., Svedhem, V., Gunthard, H., Ledergerber, B., Bucher, H., Scherrer, A., Wasmuth, J. C., Rockstroh, J., Fatkenheuer, G., Stecher, M., Schulze, N., Franke, B., Rooney, J., Rogatto, F., Garges, H., Kowalska, J., Raben, D., Peters, L., Anne, A. V., Dedes, N., Williams, E. D., Bruguera, A., Haubrich, R., Svedhem-Johansson, V., Bloch, M., Braun, D., Calmy, A., Schuttfort, G., Youle, M., Zona, S., Antinori, A., Bolokadze, N., Schwarze-Zander, C., Duvivier, C., Dragovic, G., Radoi, R., Oprea, C., Vasylyev, M., Matulionyte, R., Mulabdic, V., Marchetti, G., Kuzovatova, E., Coppola, N., Martini, S., Harxhi, A., Waehre, T., Pharris, A., Vassilenko, A., Bogner, J., Maagaard, A., Jablonowska, E., Elbirt, D., Marrone, G., Leen, C., Wyen, C., Kundro, M., Thorpe, D., Volny-Anne, A., Mendao, L., Larsen, J. F., Jakobsen, M. L., Bruun, T., Bojesen, A., Hansen, E. V., Elsing, T. W., Kristensen, D., Thomsen, S., Weide, T., and Pelchen-Matthews, A.

Subjects
0301 basic medicine, Anti-HIV Agents, Immunology, Integrase inhibitor, Blood lipids, HIV Infections, Tenofovir alafenamide, 03 medical and health sciences, 0302 clinical medicine, ANTIRETROVIRAL AGENTS, medicine, Humans, Immunology and Allergy, Protease inhibitor (pharmacology), Prospective Studies, HIV Integrase Inhibitors, 030212 general & internal medicine, Myocardial infarction, Dyslipidemias, business.industry, Incidence, Incidence (epidemiology), dyslipidemia, HIV, medicine.disease, Virology, antiretroviral agents, integrase inhibitors, 030104 developmental biology, Infectious Diseases, Anti-Retroviral Agents, Reverse Transcriptase Inhibitors, business, Dyslipidemia
Abstract

Objective: To compare the incidence of dyslipidemia in people with HIV receiving integrase inhibitors (INSTI) versus boosted protease inhibitors (PI/b) and nonnucleoside reverse transcriptase inhibitors (NNRTI) within RESPOND consortium of prospective cohorts. Methods: Participants were eligible if they were at least 18 years, without dyslipidemia and initiated or switched to a three-drug antiretroviral therapy (ART)-regimen consisting of either INSTI, NNRTI, or PI/b for the first time, between 1 January 2012 and 31 December 2018. Dyslipidemia was defined as random total cholesterol more than 240 mg/dl, HDL less than 35 mg/dl, triglyceride more than 200 mg/dl, or initiation of lipid-lowering therapy. Poisson regression was used to determine the adjusted incidence rate ratios. Follow-up was censored after 3 years or upon ART-regimen discontinuation or last lipid measurement or 31 December 2019, whichever occurred first. Results: Overall, 4577 people with HIV were eligible (INSTI = 66.9%, PI/b = 12.5%, and NNRTI = 20.6%), 1938 (42.3%) of whom were ART-naive. During 1.7 (interquartile range, 0.6 - 3.0) median years of follow-up, 1460 participants developed dyslipidemia [incidence rate: 191.6 per 1000 person-years, 95% confidence interval (CI) 182.0 - 201.7]. Participants taking INSTI had a lower incidence of dyslipidemia compared with those on PI/b (adjusted incidence rate ratio 0.71; CI 0.59 - 0.85), but higher rate compared with those on NNRTI (1.35; CI 1.15 - 1.58). Compared with dolutegravir, the incidence of dyslipidemia was higher with elvitegravir/cobicistat (1.20; CI 1.00 - 1.43) and raltegravir (1.24; CI 1.02 - 1.51), but lower with rilpivirine (0.77; CI 0.63 - 0.94). Conclusion: In this large consortium of heterogeneous cohorts, dyslipidemia was less common with INSTI than with PI/b. Compared with dolutegravir, dyslipidemia was more common with elvitegravir/cobicistat and raltegravir, but less common with rilpivirine.

Published
2021

4. Efficacy and Safety of Switching to Dolutegravir/Lamivudine (DTG/3TC) Versus Continuing a Tenofovir Alafenamide-Based 3- or 4-Drug Regimen for Maintenance of Virologic Suppression in Adults Living With HIV-1: Results Through Week 144 From the Phase 3, Non-inferiority TANGO Randomized Trial

Author

Osiyemi O, De Wit S, Ajana F, Bisshop F, Portilla J, Routy JP, Wyen C, Ait-Khaled M, Leone P, Pappa KA, Wang R, Wright J, George N, Wynne B, Aboud M, van Wyk J, and Smith KY

Subjects
dolutegravir/lamivudine, 2-drug regimen, integrase strand transfer inhibitor, treatment-experienced, durable
Abstract

BACKGROUND: Switching to dolutegravir/lamivudine (DTG/3TC) was non-inferior to continuing tenofovir alafenamide (TAF)-based regimens for maintaining virologic suppression at Week 48 of the TANGO study. Here we present Week 144 outcomes (efficacy, safety, weight, and biomarkers). METHODS: TANGO is a randomized (1:1, stratified by baseline third agent class), open-label, non-inferiority phase 3 study. Virologically suppressed (>6 months) adults with HIV-1 switched to once-daily DTG/3TC or continued TAF-based regimens. RESULTS: 741 participants received study treatment (DTG/3TC, n=369; TAF-based regimen, n=372). At Week 144, proportion of participants with HIV-1 RNA =50 copies/mL (primary endpoint, Snapshot, intention-to-treat-exposed population) after switching to DTG/3TC was 0.3% (1/369) vs 1.3% (5/372) of those continuing TAF-based regimens, demonstrating non-inferiority (adjusted treatment difference, -1.1; 95% CI, -2.4, 0.2), and favored DTG/3TC in the per-protocol analysis (adjusted treatment difference, -1.1; 95% CI, -2.3, -0.0; P=0.044). Few participants met confirmed virologic withdrawal criteria (DTG/3TC, n=0; TAF-based regimen, n=3), with no resistance observed. Drug-related adverse events were more frequent with DTG/3TC (15%; 4% led to discontinuation) than TAF-based regimens (5%; 1% led to discontinuation) through Week 144 and were comparable post-Week 48 (4%; 1% led to discontinuation in both groups). Change from baseline in lipids generally favored DTG/3TC; no clinical impact on renal function and comparable changes in inflammatory and bone biomarkers across groups were observed. CONCLUSIONS: Switching to DTG/3TC demonstrated non-inferior and durable efficacy vs continuing TAF-based regimens in treatment-experienced adults with HIV-1, with good safety and tolerability, and no resistance through 144 weeks.

Published
2022

12. Pharmacokinetics of total and unbound darunavir in HIV-1-infected pregnant women

Author

Colbers, Angela, Moltó, José, Ivanovic, Jelena, Kabeya, Kabamba, Hawkins, David, Gingelmaier, Andrea, Taylor, Graham, Weizsäcker, Katharina, Sadiq, S. Tariq, Van der Ende, Marchina, Giaquinto, Carlo, Burger, David, van der Ven, A. J. A. M., Warris, A., Nellen, J., Lyons, F., Lambert, J., Haberl, A., Faetkenheuer, G., Wyen, C., Rockstroh, J. K., Schwarze-Zander, C., Gilleece, Y., and Wood, C.

Published
2015
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13. Therapy and prophylaxis of opportunistic infections in HIV-infected patients: a guideline by the German and Austrian AIDS societies (DAIG/ÖAG) (AWMF 055/066)

Author

Thoden, J., Potthoff, A., Bogner, J. R., Brockmeyer, N. H., Esser, S., Grabmeier-Pfistershammer, K., Haas, B., Hahn, K., Härter, G., Hartmann, M., Herzmann, C., Hutterer, J., Jordan, A. R., Lange, C., Mauss, S., Meyer-Olson, D., Mosthaf, F., Oette, M., Reuter, S., Rieger, A., Rosenkranz, T., Ruhnke, M., Schaaf, B., Schwarze, S., Stellbrink, H. J., Stocker, H., Stoehr, A., Stoll, M., Träder, C., Vogel, M., Wagner, D., Wyen, C., and Hoffmann, C.

Published
2013
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15. AIDS-related progressive multifocal leukoencephalopathy in the era of HAART: report of two cases and review of the literature

Author

Wyen, C., Lehmann, C., Fatkenheuer, G., and Hoffmann, C.

Subjects
HIV (Viruses) -- Drug therapy, Highly active antiretroviral therapy -- Health aspects, Anti-HIV agents -- Dosage and administration, Antiviral agents -- Dosage and administration, Health
Abstract

Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease of the central nervous system. It is caused by the JC virus (JCV), a human polyomavirus replicating in human glial cells. PML is the result of the reactivation of latent JCV infection that usually occurs in the setting of cellular immunodeficiencies such as HIV-1 infection. Epidelniologic data suggest that the impact of highly active antiretroviral therapy (HAART) on the incidence of PML is less profound than seen with other opportunistic infections. Given the lack of an effective and specific therapy for PML, HAART remains the only therapeutic option in patients with PML. However, a significant number of cases appear unresponsive to antiretroviral therapy. Moreover, there is growing data on unexpected inflammatory cases of PML after initiation of HAART. Thus, PML will remain a relevant cause of morbidity and mortality in HIV-1-infected patients. Here we report two cases of PML, along with a concise review of the literature on this important disease.

Published
2005

18. Predictors of serofast state after treatment for early syphilis in HIV‐infected patients

Author

Paul, G, primary, Wesselmann, J, additional, Adzic, D, additional, Malin, JJ, additional, Suarez, I, additional, Priesner, V, additional, Kümmerle, T, additional, Wyen, C, additional, Jung, N, additional, Bremen, K, additional, Schlabe, S, additional, Wasmuth, J‐C, additional, Boesecke, C, additional, Fätkenheuer, G, additional, Rockstroh, J, additional, Schwarze‐Zander, C, additional, and Lehmann, C, additional

Published
2020
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19. Switching to DTG/3TC fixed-dose combination (FDC) Is non-inferior to continuing a TAF-based regimen in maintaining virologic suppression through 48 weeks (TANGO Study)

Author

Van Wyk, J., primary, Ajana, F., additional, Bisshop, F., additional, De Wit, S., additional, Osiyemi, Y., additional, Portilla, J., additional, Routy, J., additional, Wyen, C., additional, Ait-Khaled, M., additional, Nascimento, M., additional, Pappa, K., additional, Wang, R., additional, Wright, J., additional, Tenorio, A., additional, Wynne, B., additional, Aboud, M., additional, Gartland, M., additional, Smith, K., additional, and El-Bahy, Y., additional

Published
2020
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24. Parameter estimates for trends and patterns of excess mortality among persons on ART in high-income european settings

Author

TRICKEY, A., VAN SIGHEM, A., STOVER, J., ABGRALL, S., GRABAR, S., BONNET, Fabrice, BERENGUER, J., WYEN, C., CASABONA, J., D'ARMINIO MONFORTE, A., CAVASSINI, M., DEL AMO, J., ZANGERLE, R., GILL, M. J., OBEL, N., STERNE, J. A. C., MAY, M. T., AP-HP - Hôpital Antoine Béclère [Clamart], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre de recherche en épidémiologie et santé des populations (CESP), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay, Institut Pierre Louis d'Epidémiologie et de Santé Publique (iPLESP), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Bordeaux population health (BPH), and Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
AIDS, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, death, cause-specific, duration, HIV, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, cohort, United Nations Programme on HIV/AIDS
Abstract

International audience; INTRODUCTION: HIV cohort data from high-income European countries were compared to the UNAIDS Spectrum modelling parameters for these same countries to validate mortality rates and excess mortality estimates for people living with HIV (PLHIV) on antiretroviral therapy (ART). METHODS: Data from 2000-2015 were analysed from the Antiretroviral Therapy Cohort Collaboration (ART-CC) for Austria, Denmark, France, Italy, the Netherlands, Spain, and Switzerland. Flexible parametric models were used to compare All-cause mortality rates in the ART-CC and Spectrum. The percentage of AIDS-related deaths and excess mortality (both are the same within Spectrum) were compared, with excess mortality defined as that in excess of the general population mortality.RESULTS: Analyses included 94026 PLHIV with 585784 person-years of follow-up, from which there were 5515 deaths. All-cause annual mortality rates in Spectrum for 2000-2003 were 0.0121, reducing to 0.0078 in 2012-2015, whilst the ART-CC's corresponding annual mortality rates were 0.0151 (95% confidence interval [95%CI]: 0.0130-0.0171) reducing to 0.0049 (95%CI: 0.0039-0.0060). The percentage of AIDS-related deaths in Spectrum was 74.7% in 2000-2003, dropping to 43.6% in 2012-15. In the ART-CC, AIDS-related mortality comprised 45.3% (95%CI: 38.4%-52.9%) of mortality in 2000-2003 and 26.7% (95%CI: 19.0%, 46.0%) between 2012-2015. Excess mortality in the ART-CC was broadly similar to the Spectrum estimates, dropping from 75.3% (95%CI: 60.3%-95.2%) in 2000-2003 to 30.7% (95%CI: 25.5%-63.7%) in 2012-2015.CONCLUSIONS: All-cause mortality assumptions for PLHIV on ART in high-income European settings should be adjusted in Spectrum to be higher in 2000-2003 and decline more quickly to levels currently captured for recent years.

Published
2019

27. Acceptance and tolerability of an adjuvanted nH1N1 vaccine in HIV-infected patients in the cologne-bonn cohort

Author

Steffens B, Kümmerle T, Koch S, Birtel A, Schwarze-Zander C, Emmelkamp J, Kern WV, Hertenstein C, Wyen C, Lehmann C, Cornely OA, Rockstroh J, and Fätkenheuer G

Subjects
nH1N1, influenza, HIV, vaccine, tolerability, adverse events, safety, acceptance, Medicine
Abstract

Abstract Objective To evaluate the acceptance and tolerability of the nH1N1 2009 vaccine in HIV-positive individuals. Method 758 patients were included in this prospective study. Different study populations were formed: The Tolerability Study Group consists of HIV-infected patients who visited three outpatient clinics (Cologne, Bonn, Freiburg) during a predefined time period. Patients were offered nH1N1 vaccination. Those accepting were administered a standard dose AS03 adjuvant nH1N1 vaccine. Questionnaires to report side effects occurring within 7 days after immunization were handed out. In a substudy conducted during the same time period, acceptance towards immunization was recorded. This Acceptance Study Group consists of all HIV-infected patients visiting the Cologne clinic. They were offered vaccination. In case of refusal, motivation was recorded. Results In the Tolerability Study Group, a total of 475 patient diaries returned in the three study centres could be evaluated, 119 of those (25%) reported no side effects. Distribution of symptoms was as follows: Pain 285/475 patients (60%), swelling 96 (20%), redness 54 (11%), fever 48/475 (10%), muscle/joint ache 173 (36%), headache 127 (27%), and fatigue 210 (44%). Association of side effects with clinical data was calculated for patients in Cologne and Bonn. Incidence of side effects was significantly associated with CDC stages A, B compared to C, and with a detectable viral load (> 50 copies/mL). No correlation was noted for CD4 cell count, age, gender or ethnicity. In the Acceptance Study Group, 538 HIV-infected patients were offered vaccination, 402 (75%) accepted, while 136 (25%) rejected. Main reasons for rejection were: Negative media coverage (35%), indecisiveness with preference to wait until a later date (23%), influenza not seen as personal threat (19%) and scepticism towards immunization in general (10%). Conclusion A total of 622 HIV-infected patients were vaccinated against nH1N1-influenza in the three study centres. No severe adverse events were reported. The tolerability was in most parts comparable to general population. Acceptance rate towards influenza vaccination was high (75%). Those refusing the immunization mentioned negative media coverage as the major influence on their decision.

Published
2011
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28. Predictors of serofast state after treatment for early syphilis in HIV‐infected patients.

Author

Paul, G, Wesselmann, J, Adzic, D, Malin, JJ, Suarez, I, Priesner, V, Kümmerle, T, Wyen, C, Jung, N, Bremen, K, Schlabe, S, Wasmuth, J‐C, Boesecke, C, Fätkenheuer, G, Rockstroh, J, Schwarze‐Zander, C, and Lehmann, C

Subjects
ADRENOCORTICAL hormones, AGGLUTINATION tests, HIV-positive persons, MEDICAL records, SERODIAGNOSIS, SYPHILIS, TREATMENT effectiveness, DESCRIPTIVE statistics, ACQUISITION of data methodology
Abstract

Objectives: Non‐treponemal serological tests are used to monitor treatment response during syphilis infection. Syphilis‐ and HIV‐coinfected patients may experience incomplete resolution in non‐treponemal titres, which is referred to as the serofast state. The goal of this study was to evaluate risk factors for serofast state in HIV‐infected patients. Methods: From November 2015 to June 2018, 1530 HIV‐positive patients were tested for syphilis using a Treponema pallidum particle agglutination (TPPA) assay. Among TPPA‐positive patients, medical records were reviewed for early syphilis infection. Serofast state was defined as a less than four‐fold decrease in non‐treponemal antibody titres during a 6‐month follow‐up period in the absence of symptoms of syphilis. Baseline characteristics were tested as predictive factors of serological response. Results: In all, 515 patients (33.7%) tested positive in TPPA assays, and in 163 patients at least one previous syphilis infection was documented. A total of 61 out of 163 patients (37.4%) were in a serofast state. A history of previous syphilis infection (61 vs. 43%; P = 0.04) was more common in serofast patients than in patients with serological cure after 6 months. Non‐treponemal titres ≥ 1:32 before therapy (47 vs. 25%; P = 0.005) and adjunctive corticosteroids to prevent the Jarisch–Herxheimer reaction (35% vs 15%; P = 0.006) were associated with serological cure after 6 months, but corticosteroid therapy had no influence at 12 months. The intensity of syphilis treatment did not affect serological cure. Conclusion: Corticosteroids for prevention of the Jarisch–Herxheimer reaction were associated with earlier serological cure. Although serological response is the accredited surrogate method to monitor syphilis treatment, the biological significance of the serofast state remains unclear. [ABSTRACT FROM AUTHOR]

Published
2021
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31. To prescribe, or not to prescribe: decision making in HIV-1 post-exposure prophylaxis

Author

Scholten, M., Suarez, I., Platten, M., Kuemmerle, T., Jung, N., Wyen, C., Ernst, A., Horn, C., Burst, V., Suarez, V., Rybniker, J., Faetkenheuer, G., Lehmann, C., Scholten, M., Suarez, I., Platten, M., Kuemmerle, T., Jung, N., Wyen, C., Ernst, A., Horn, C., Burst, V., Suarez, V., Rybniker, J., Faetkenheuer, G., and Lehmann, C.

Abstract

ObjectivesWe investigated the trend in usage of post-exposure prophylaxis (PEP) after HIV-1 risk exposure and evaluated PEP prescription decision making of physicians according to guidelines. MethodsAll PEP consultations from January 2014 to December 2016 in patients presenting at the University Hospital of Cologne (Germany) were retrospectively analysed. HIV risk contacts included sexual and occupational exposure. The European AIDS Clinical Society (EACS) Guidelines for HIV PEP (version 9.0, 2017) were used for assessment. ResultsA total of 649 patients presented at the emergency department (ED) or the clinic for infectious diseases (IDC) for PEP consultations. A continuous increase in the number of PEP requests was recorded: 189 in 2014, 208 in 2015 and 252 in 2016. PEP consultations in men who have sex with men (MSM) showed a remarkable increase in 2016 (2014, n = 96; 2015, n = 101; 2016, n = 152). Decisions taken by physicians with a specialization in infectious diseases (n = 547) included 61 (11%) guideline-discordant prescriptions [2014: 14% (n = 22); 2015: 9% (n = 16); 2016: 11% (n = 23)]. Among these, sexual exposure accounted for 45 (74%) cases, including 15 cases of nonconsensual sex, while occupational exposure accounted for 14 (23%) cases and other exposure two cases (3%). The main reason for guideline-discordant PEP prescriptions was emotional stress of the patient (n = 37/61). ConclusionsPEP prescriptions are increasing and decision making is influenced by patients' emotional stress, but PEP prescriptions should be strictly administered according to risk assessment.

Published
2018

32. Longitudinal analysis of proviral HIV-DNA

Author

Heger, E., Peters, S., Onyuro, M., Kuemmerle, T., Voigt, E., Di Cristanziano, V., Sierra, S., Huesgen, L., Kulartz, H., Kaiser, R., Wyen, C., Knops, E., Heger, E., Peters, S., Onyuro, M., Kuemmerle, T., Voigt, E., Di Cristanziano, V., Sierra, S., Huesgen, L., Kulartz, H., Kaiser, R., Wyen, C., and Knops, E.

Published
2018

35. The pharmacokinetics, safety and efficacy of tenofovir and emtricitabine in HIV-1-infected pregnant women

Author

Colbers, Ap, Hawkins, Da, Gingelmaier, A, Kabeya, K, Rockstroh, Jk, Wyen, C, Weizsäcker, K, Sadiq, St, Ivanovic, J, Giaquinto, Carlo, Taylor, Gp, Moltó, J, Burger, Dm, and Panna, Network

Subjects
Adult, medicine.medical_specialty, Anti-HIV Agents, Pregnancy Trimester, Third, Immunology, Organophosphonates, HIV Infections, Emtricitabine, Deoxycytidine, Young Adult, Pharmacokinetics, Acquired immunodeficiency syndrome (AIDS), Pregnancy, medicine, Humans, Immunology and Allergy, Pregnancy Complications, Infectious, Tenofovir, Nucleoside analogue, business.industry, Obstetrics, Adenine, Poverty-related infectious diseases [N4i 3], Area under the curve, Gestational age, Viral Load, Fetal Blood, medicine.disease, Infectious Disease Transmission, Vertical, Confidence interval, Surgery, Europe, Infectious Diseases, HIV-1, Female, Poverty-related infectious diseases Infectious diseases and international health [N4i 3], business, Viral load, medicine.drug
Abstract

Contains fulltext : 117827.pdf (Publisher’s version ) (Closed access) OBJECTIVE:: To describe the pharmacokinetics of tenofovir and emtricitabine in the third trimester of pregnant HIV-infected women and at postpartum. DESIGN:: A nonrandomized, open-label, multicentre phase IV study in HIV-infected pregnant women recruited from HIV treatment centres in Europe. METHODS:: HIV-infected pregnant women treated with the nucleotide/nucleoside analogue reverse transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate (TDF 300 mg; equivalent to 245 mg tenofovir disoproxil) and/or emtricitabine (FTC 200 mg) were included in the study. Twenty-four-hour pharmacokinetic curves were recorded in the third trimester (preferably week 33) and postpartum (preferably week 4-6). Collection of a cord blood sample and maternal sample at delivery was optional. Pharmacokinetic parameters were calculated using WinNonlin software version 5.3. Statistical analysis was conducted using SPSS version 16.0. RESULTS:: Thirty-four women were included in the analysis. Geometric mean ratios of third trimester vs. postpartum [90% confidence interval (CI)] were 0.77 (0.71-0.83) for TDF area under the curve (AUC0-24 h); 0.81 (0.68-0.96) for TDF Cmax and 0.79 (0.70-0.90) for TDF C24 h and 0.75 (0.68-0.82) for FTC AUC0-24 h; and 0.87 (0.77-0.99) for FTC Cmax and 0.77 (0.52-1.12) for FTC C24 h. The viral load close to delivery was less than 200 copies/ml in all but one patient, the average gestational age at delivery was 38 weeks. All children were tested HIV-negative and no congenital abnormalities were reported. CONCLUSION:: Although pharmacokinetic exposure of the NRTIs TDF and FTC during pregnancy is approximately 25% lower, this was not associated with virological failure in this study and did not result in mother-to-child transmission.

Published
2013

36. Higher rates of neuropsychiatric adverse events leading to dolutegravir discontinuation in women and older patients

Author

Hoffmann, C., Welz, T., Sabranski, M., Kolb, M., Wolf, E., Stellbrink, H-J, Wyen, C., Hoffmann, C., Welz, T., Sabranski, M., Kolb, M., Wolf, E., Stellbrink, H-J, and Wyen, C.

Abstract

ObjectivesDolutegravir (DTG), a second-generation integrase strand transfer inhibitor (INSTI), is now among the most frequently used antiretroviral agents. However, recent reports have raised concerns about potential neurotoxicity. MethodsWe performed a retrospective analysis of a cohort of HIV-infected patients who had initiated an INSTI in two large German out-patient clinics between 2007 and 2016. We compared discontinuation rates because of adverse events (AEs) within 2 years of starting treatment with dolutegravir, raltegravir or elvitegravir/cobicistat. We also evaluated factors associated with dolutegravir discontinuation. ResultsA total of 1950 INSTI-based therapies were initiated in 1704 patients eligible for analysis within the observation period. The estimated rates of any AE and of neuropsychiatric AEs leading to discontinuation within 12 months were 7.6% and 5.6%, respectively, for dolutegravir (n = 985), 7.6% and 0.7%, respectively, for elvitegravir (n = 287), and 3.3% and 1.9%, respectively, for raltegravir (n = 678). Neuropsychiatric AEs leading to dolutegravir discontinuation were observed more frequently in women [hazard ratio (HR) 2.64; 95% confidence interval (CI) 1.23-5.65; P = 0.012], in patients older than 60 years (HR: 2.86; 95% CI: 1.42-5.77; P = 0.003) and in human leucocyte antigen (HLA)-B*5701-negative patients who initiated abacavir at the same time (HR: 2.42; 95% CI: 1.38-4.24; P = 0.002). ConclusionsIn this large cohort, the rate of discontinuation of dolutegravir because of neuropsychiatric adverse events was significantly higher than for other INSTIs, at almost 6% within 12 months. Despite the limitations of this retrospective study, the almost three-fold higher discontinuation rates observed amongst women and older patients underscore the need for further investigation, especially in patient populations usually underrepresented in clinical trials.

Published
2017

37. HIV-INFECTED PATIENTS WITH RELAPSED NON-HODGKIN LYMPHOMA (NHL) OR HODGKIN LYMPHOMA (HL): RESULTS FROM THE GERMAN HIV-RELATED LYMPHOMA COHORT STUDY

Author

Schommers, P., Hentrich, M., Gillor, D., Wyen, C., Wolf, T., Wasmuth, J-C., Bogner, J., Spinner, C., Esser, S., Jensen, B., Mueller, M., Schleicher, A., Faetkenheuer, G., Hoffmann, C., Schommers, P., Hentrich, M., Gillor, D., Wyen, C., Wolf, T., Wasmuth, J-C., Bogner, J., Spinner, C., Esser, S., Jensen, B., Mueller, M., Schleicher, A., Faetkenheuer, G., and Hoffmann, C.

Published
2017

38. Relapsed HIV-associated lymphoma: results from the German HIV-related lymphoma cohort study

Author

Hentrich, M., Schommers, P., Wyen, C., Gillor, D., Wolf, T., Wasmuth, J. -C., Mueller, M., Siehl, J., Bogner, J., Spinner, C., Esser, S., Jensen, B., Schleicher, A., Faetkenheuer, G., Hoffmann, C., Hentrich, M., Schommers, P., Wyen, C., Gillor, D., Wolf, T., Wasmuth, J. -C., Mueller, M., Siehl, J., Bogner, J., Spinner, C., Esser, S., Jensen, B., Schleicher, A., Faetkenheuer, G., and Hoffmann, C.

Published
2017

40. Atazanavir exposure is effective during pregnancy regardless of tenofovir use

Author

Colbers, A, Hawkins, D, Hidalgo-Tenorio, C, Ende, Marchina, Gingelmaier, A, Weizsacker, K, Kabeya, K, Taylor, G, Rockstroh, J, Lambert, J, Molto, J, Wyen, C, Sadiq, S T, Ivanovic, J, Giaquinto, C, Burger, D, Network, Panna, Internal Medicine, and Pediatrics

Subjects
Adult, Tenofovir, Adolescent, Pregnancy Trimester, Third, Atazanavir Sulfate, Human immunodeficiency virus (HIV), Gestational Age, HIV Infections, Pharmacology, medicine.disease_cause, Drug Administration Schedule, Pharmacokinetics, Drug Therapy, Pregnancy, medicine, Humans, Pharmacology (medical), Viral, Third, Ritonavir, business.industry, Medicine (all), virus diseases, HIV Protease Inhibitors, Viral Load, medicine.disease, Atazanavir, Area Under Curve, Drug Monitoring, Drug Therapy, Combination, Female, HIV-1, RNA, Viral, Reverse Transcriptase Inhibitors, Treatment Outcome, Infectious Diseases, lnfectious Diseases and Global Health Radboud Institute for Health Sciences [Radboudumc 4], Combination, RNA, Pregnancy Trimester, business, medicine.drug
Abstract

Background We studied the effect of pregnancy on atazanavir pharmacokinetics in the presence and absence of tenofovir. Methods This was a non-randomized, open-label, multicentre Phase IV study in HIV-infected pregnant women recruited from European HIV treatment centres. HIV-infected pregnant women treated with boosted atazanavir (300/100 mg or 400/100 mg atazanavir/ ritonavir) as part of their combination antiretroviral therapy (cART) were included in the study. 24 h pharmacokinetic curves were recorded in the third trimester and postpartum. Collection of a cord blood and maternal sample at delivery was optional. Results 31 patients were included in the analysis, 21/31 patients used tenofovir as part of cART. Median (range) gestational age at delivery was 39 weeks (36–42). Approaching delivery 81% (25 patients) had an HIV viral load 0-24h, 0.70 (0.61, 0.80) for Cmax and 0.59 (0.48, 0.72) for C24h. No statistical difference in pharmacokinetic parameters was found between patients using tenofovir versus no tenofovir. None of the patients showed atazanavir concentrations Conclusions Despite 34% lower atazanavir exposure during pregnancy, atazanavir/ritonavir 300/100 mg once daily generates effective concentrations for protease inhibitor (PI)-naive patients, even if co-administered with tenofovir. For treatment-experienced patients (with relevant PI resistance mutations) therapeutic drug monitoring of atazanavir should be considered to adapt the atazanavir/ritonavir dose on an individual basis. ClinicalTrials.gov number NCT00825929.

Published
2015

41. Maraviroc Pharmacokinetics in HIV-1-Infected Pregnant Women

Author

Colbers, A, Best, B, Schalkwijk, S, Wang, J, Stek, A, Hidalgo Tenorio, C, Hawkins, D, Taylor, G, Kreitchmann, R, Burchett, S, Haberl, A, Kabeya, K, Van Kasteren, M, Smith, E, Capparelli, E, Burger, D, Mirochnick, M, Van Der Ende, ME, Erasmus, M, Van Der Ven, AJAM, Nellen, J, Moltó, J, Nicastri, E, Giaquinto, C, Gingelmaier, A, Lyons, F, Lambert, J, Wyen, C, Faetkenheuer, G, Rockstroh, JK, Schwarze-Zander, C, Sadiq, ST, Gilleece, Y, Wood, C, Buschur, S, Jackson, C, Paul, M, Florez, C, Bryan, P, Stone, M, Katz, M, Auguste, R, Wiznia, A, Bruder, KL, Lewis, G, Casey, D, Losso, MH, Ivalo, SA, Hakim, A, Deveikis, A, Batra, J, Alvarez, JJ, Knapp, KM, Sublette, N, Wride, T, Febo, IL, Santos, R, and Tamayo, V

Abstract

© The Author 2015. Published by Oxford University Press on behalf of the Infectious. Objective.To describe the pharmacokinetics of maraviroc in human immunodeficiency virus (HIV)-infected women during pregnancy and post partum. Methods.HIV-infected pregnant women receiving maraviroc as part of clinical care had intensive steady-state 12-hour pharmacokinetic profiles performed during the third trimester and ≥2 weeks after delivery. Cord blood samples and matching maternal blood samples were taken at delivery. The data were collected in 2 studies: P1026 (United States) and PANNA (Europe). Pharmacokinetic parameters were calculated. Results.Eighteen women were included in the analysis. Most women (12; 67%) received 150 mg of maraviroc twice daily with a protease inhibitor, 2 (11%) received 300 mg twice daily without a protease inhibitor, and 4 (22%) had an alternative regimen. The geometric mean ratios for third-trimester versus postpartum maraviroc were 0.72 (90% confidence interval,. 60-.88) for the area under the curve over a dosing interval (AUCtau) and 0.70 (0.58-0.85) for the maximum maraviroc concentration. Only 1 patient showed a trough concentration (Ctrough) below the suggested target of 50 ng/mL, both during pregnancy and post partum. The median ratio of maraviroc cord blood to maternal blood was 0.33 (range, 0.03-0.56). The viral load close to delivery was

Published
2015

42. Etravirine pharmacokinetics in HIV-infected pregnant women

Author

Mulligan, N. (Nikki), Schalkwijk, S. (Stein), Best, B.M. (Brookie M.), Colbers, A. (Angela), Wang, J. (Jiajia), Capparelli, E.V. (Edmund V.), Moltó, J. (José), Stek, A.M. (Alice M.), Taylor, G. (Graham), Smith, E. (Elizabeth), Tenorio, C.H. (Carmen Hidalgo), Chakhtoura, N. (Nahida), Kasteren, M.E.E. (Marjo) van, Fletcher, C.V. (Courtney V.), Mirochnick, M. (Mark), Burger, D.M. (David), Antinori, A. (Andrea), Ende, I.E. (Ineke) van der, Faetkenheuer, G. (Gerd), Giaquinto, C. (Carlo), Gilleece, Y. (Yvonne), Gingelmaier, A. (Andrea), Haberl, A. (Annette), Hawkins, D. (David), Ivanovic, J. (Jelena), Kabeya, K. (Kabamba), Lambert, J. (Julien), Lyons, F. (Fyona), Nellen, J.F.J.B. (Jeannine), Nicastri, E. (Emanuelle), Rockstroh, J. (Jürgen), Schwarze-zander, C., Ruiter, A. (Annemiek de), Sadiq, T. (Tariq), Ven, A. (André van der), Weizsäcker, K. (Katharina), Wood, C. (Chris), Wyen, C. (Christoph), Mulligan, N. (Nikki), Schalkwijk, S. (Stein), Best, B.M. (Brookie M.), Colbers, A. (Angela), Wang, J. (Jiajia), Capparelli, E.V. (Edmund V.), Moltó, J. (José), Stek, A.M. (Alice M.), Taylor, G. (Graham), Smith, E. (Elizabeth), Tenorio, C.H. (Carmen Hidalgo), Chakhtoura, N. (Nahida), Kasteren, M.E.E. (Marjo) van, Fletcher, C.V. (Courtney V.), Mirochnick, M. (Mark), Burger, D.M. (David), Antinori, A. (Andrea), Ende, I.E. (Ineke) van der, Faetkenheuer, G. (Gerd), Giaquinto, C. (Carlo), Gilleece, Y. (Yvonne), Gingelmaier, A. (Andrea), Haberl, A. (Annette), Hawkins, D. (David), Ivanovic, J. (Jelena), Kabeya, K. (Kabamba), Lambert, J. (Julien), Lyons, F. (Fyona), Nellen, J.F.J.B. (Jeannine), Nicastri, E. (Emanuelle), Rockstroh, J. (Jürgen), Schwarze-zander, C., Ruiter, A. (Annemiek de), Sadiq, T. (Tariq), Ven, A. (André van der), Weizsäcker, K. (Katharina), Wood, C. (Chris), and Wyen, C. (Christoph)

Abstract

__Background__ The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women. __Methods__ IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women. Intensive steady-state 12-h pharmacokinetic profiles were performed from 2nd trimester through postpartum. Etravirine was measured at two labs using validated ultra performance liquid chromatography (detection limits: 0.020 and 0.026 mcg/mL). __Results__ Fifteen women took etravirine 200 mg twice-daily. Etravirine AUC0-12 was higher in the 3rd trimester compared to paired postpartum data by 34% (median 8.3 vs. 5.3 mcg*h/mL, p = 0.068). Etravirine apparent oral clearance was significantly lower in the 3rd trimester of pregnancy compared to paired postpartum data by 52% (median 24 vs. 38 L/h, p = 0.025). The median ratio of cord blood to maternal plasma concentration at delivery was 0.52 (range: 0.19-4.25) and no perinatal transmission occurred. __Conclusion__ Etravirine apparent oral clearance is reduced and exposure increased during the third trimester of pregnancy. Based on prior dose-ranging and safety data, no dose adjustment is necessary for maternal health but the effects of etravirine in utero are unknown. Maternal health and infant outcomes should be closely monitored until further infant safety data are available. __Clinical Trial registration:__ The IMPAACT protocol P1026s and PANNA study are registered at ClinicalTrials.gov under NCT00042289 and NCT00825929.

Published
2016
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43. Dose-intensive chemotherapy including rituximab is highly effective but toxic in human immunodeficiency virus-infected patients with Burkitt lymphoma/leukemia: parallel study of 81 patients

Author

Xicoy, B, Ribera, JM, Muller, M, Garcia, O, Hoffmann, C, Oriol, A, Hentrich, M, Grande, C, Wasmuth, JC, Esteve, J, van Lunzen, J, del Potro, E, Knechten, H, Brunet, S, Mayr, C, Escoda, L, Schommers, P, Alonso, N, Vall-Llovera, F, Perez, M, Morgades, M, Gonzalez, J, Fernandez, A, Thoden, J, Gokbuget, N, Hoelzer, D, Fatkenheuer, G, and Wyen, C

Subjects
Burkitt lymphoma or leukemia, prognostic factors, Specific chemotherapy, HIV infection
Abstract

The results of intensive immunochemotherapy were analyzed in human immunodeficiency virus (HIV)-related Burkitt lymphoma/leukemia (BLL) in two cohorts (Spain and Germany). Alternating cycles of chemotherapy were administered, with dose reductions for patients over 55 years. Eighty percent of patients achieved remission, 11% died during induction, 9% failed and 7% died in remission. Four-year overall survival (OS) and progression-free survival (PFS) probabilities were 72% (95% confidence interval [CI]: 62-82%) and 71% (95% CI: 61-81%). CD4 T-cell count < 200/mu L and bone marrow involvement were associated with poor OS (hazard ratio [HR] 3.2 [1.2-8.3] and HR 2.7 [1.1-6.6]) and PFS (HR 3.5 [1.3-9.1] and HR 2.4 [1-5.7]), bone marrow involvement with poor disease-free survival (DFS) (HR 14.4 [1.7-119.7] and Eastern Cooperative Oncology Group (ECOG) score > 2 (odds ratio [OR] 11.9 [1.4-99.9]) with induction death. In HIV-related BLL, intensive immunochemotherapy was feasible and effective, but toxic. Prognostic factors were performance status, CD4 T-cell count and bone marrow involvement.

Published
2014

45. Atazanavir exposure is effective during pregnancy regardless of tenofovir use

Author

Colbers, A., Hawkins, D., Hidalgo-Tenorio, C., Ende, M. van der, Gingelmaier, A., Weizsacker, K., Kabeya, K., Taylor, G., Rockstroh, J., Lambert, J., Molto, J., Wyen, C., Sadiq, S.T., Ivanovic, J., Giaquinto, C., Burger, D.M., Colbers, A., Hawkins, D., Hidalgo-Tenorio, C., Ende, M. van der, Gingelmaier, A., Weizsacker, K., Kabeya, K., Taylor, G., Rockstroh, J., Lambert, J., Molto, J., Wyen, C., Sadiq, S.T., Ivanovic, J., Giaquinto, C., and Burger, D.M.

Abstract

Item does not contain fulltext, BACKGROUND: We studied the effect of pregnancy on atazanavir pharmacokinetics in the presence and absence of tenofovir. METHODS: This was a non-randomized, open-label, multicentre Phase IV study in HIV-infected pregnant women recruited from European HIV treatment centres. HIV-infected pregnant women treated with boosted atazanavir (300/100 mg or 400/100 mg atazanavir/ritonavir) as part of their combination antiretroviral therapy (cART) were included in the study. 24 h pharmacokinetic curves were recorded in the third trimester and postpartum. Collection of a cord blood and maternal sample at delivery was optional. RESULTS: 31 patients were included in the analysis, 21/31 patients used tenofovir as part of cART. Median (range) gestational age at delivery was 39 weeks (36-42). Approaching delivery 81% (25 patients) had an HIV viral load <50 copies/ml, all <1,000 copies/ml. Least squares means ratios (90% CI) of atazanavir pharmacokinetic parameters third trimester/postpartum were: 0.66 (0.57, 0.75) for AUC0-24h, 0.70 (0.61, 0.80) for Cmax and 0.59 (0.48, 0.72) for C24h. No statistical difference in pharmacokinetic parameters was found between patients using tenofovir versus no tenofovir. None of the patients showed atazanavir concentrations <0.15 mg/l (target for treatment-naive patients). One baby had a congenital abnormality, which was not likely to be related to atazanavir/ritonavir use. None of the children were HIV-infected. CONCLUSIONS: Despite 34% lower atazanavir exposure during pregnancy, atazanavir/ritonavir 300/100 mg once daily generates effective concentrations for protease inhibitor (PI)-naive patients, even if co-administered with tenofovir. For treatment-experienced patients (with relevant PI resistance mutations) therapeutic drug monitoring of atazanavir should be considered to adapt the atazanavir/ritonavir dose on an individual basis.ClinicalTrials.gov number NCT00825929.

Published
2015

46. Hodgkin lymphoma is as common as non-Hodgkin lymphoma in HIV-positive patients with sustained viral suppression and limited immune deficiency: a prospective cohort study

Author

Hoffmann, C., Hentrich, M., Gillor, D., Behrens, G., Jensen, B., Stoehr, A., Esser, S., van Lunzen, J., Krznaric, I., Mueller, M., Oette, M., Hensel, M., Thoden, J., Faetkenheuer, G., Wyen, C., Hoffmann, C., Hentrich, M., Gillor, D., Behrens, G., Jensen, B., Stoehr, A., Esser, S., van Lunzen, J., Krznaric, I., Mueller, M., Oette, M., Hensel, M., Thoden, J., Faetkenheuer, G., and Wyen, C.

Abstract

ObjectivesThe incidence of HIV-related non-Hodgkin lymphoma (NHL) but not that of Hodgkin lymphoma (HL) has been declining. The aim of the study was to compare HIV-infected patients with NHL and HL with respect to antiretroviral therapy (ART) exposure at the time of lymphoma diagnosis. MethodsHIV-infected patients with NHL and HL included in a prospective multicentre cohort study since January 2005 were compared with respect to ART exposure and viral load at the time of lymphoma diagnosis. ResultsAs of 31 December 2012, data for 329 patients with NHL and 86 patients with HL from 31 participating centres were available. Patients with HL were more likely to be on ART (73.5% vs. 39.1%, respectively; P<0.001) and more frequently had a viral load below the detection limit (57.3% vs. 27.9%, respectively; P<0.001) than patients with NHL. The proportion of patients with HL was 8.0% in ART-naive patients, 34.8% in patients with current HIV RNA <50 HIV-1 RNA copies/mL, and 50.0% in patients with both HIV RNA <50 copies/mL for >12 months and a CD4 cell count of >200 cells/L. Of note, 45.8% of all patients with NHL were not currently on ART and had a CD4 count of <350 cells/L. ConclusionsThis prospective cohort study shows that HL was as common as NHL in patients with sustained viral suppression and limited immune deficiency. In contrast to NHL, the majority of patients with HL were on effective ART, suggesting that ART provides insufficient protection from developing HL. The high proportion of untreated patients with NHL suggests missed opportunities for earlier initiation of ART.

Published
2015

47. Lymphoma-associated mortality in the German HIV-lymphoma cohort study

Author

Hentrich, M., Schommers, P., Gillor, D., Mueller, M., Stoehr, A., Schultze, A., Jensen, B., Wasmuth, J. -C., Wolf, T., Siehl, J., Oette, M., Taylor, N., Zinngrebe, B., Hensel, M., Horst, H. -A., Faetkenheuer, G., Wyen, C., Hoffmann, C., Hentrich, M., Schommers, P., Gillor, D., Mueller, M., Stoehr, A., Schultze, A., Jensen, B., Wasmuth, J. -C., Wolf, T., Siehl, J., Oette, M., Taylor, N., Zinngrebe, B., Hensel, M., Horst, H. -A., Faetkenheuer, G., Wyen, C., and Hoffmann, C.

Published
2015

48. Cytochrome P450 2B6 (CYP2B6) and constitutive androstane receptor (CAR) polymorphisms are associated with early discontinuation of efavirenz-containing regimens

Author

Wyen, C, Hendra, H, Siccardi, M, Platten, M, Jaeger, H, Harrer, T, Esser, S, Bogner, J R, Brockmeyer, N H, Bieniek, B, Rockstroh, J, Hoffmann, C, Stoehr, A, Michalik, C, Dlugay, V, Jetter, A, Knechten, H, Klinker, H, Skaletz-Rorowski, A, Fätkenheuer, G, Egan, D, Back, D J, Owen, A, University of Zurich, and Owen, A

Subjects
3004 Pharmacology, 10199 Clinic for Clinical Pharmacology and Toxicology, 2736 Pharmacology (medical), 610 Medicine & health, 2725 Infectious Diseases, 2726 Microbiology (medical)
Published
2011

50. Verträglichkeit des adjuvantierten nH1N1-Impfstoffes Pandemrix und Akzeptanz des Impfangebots bei einer Kohorte HIV-infizierter Patienten der Universitätskliniken Köln und Bonn

Author

Kuemmerle, T, Steffens, B, Koch, S, Birtel, A, Schwarze-Zander, C, Emmelkamp, J, Hertenstein, C, Wyen, C, Lehmann, C, Cornely, OA, Rockstroh, J, and Fätkenheuer, G

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Zielsetzung: Die Impfung gegen die nH1N1-Influenza ist für alle HIV-positiven Patienten empfohlen. Mit dieser Untersuchung wurde die Kurzzeit-Verträglichkeit der Impfung mit Pandemrix bei HIV-Patienten an den Unikliniken Köln und Bonn erfasst. Zudem wurden Daten zur Akzeptanz der Impfung[for full text, please go to the a.m. URL], 10. Kongress für Infektionskrankheiten und Tropenmedizin (KIT 2010)

Published
2010
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