Kooperativer Bibliotheksverbund

In: The Journal of Infectious Diseases, Oxford University Press (OUP), Vol. 220, No. 10 ( 2019-10-08), p. 1635-1644

Kurzfassung: Despite high hepatitis C virus (HCV) treatment rates, HCV incidence among human immunodeficiency virus (HIV)–infected men who have sex with men (HIV-infected MSM) in Germany rose before HCV direct-acting antivirals (DAAs). We model what intervention can achieve the World Health Organization (WHO) elimination target of an 80% reduction in HCV incidence by 2030 among HIV-infected MSM in Berlin. Methods An HCV transmission model among HIV-diagnosed MSM was calibrated to Berlin (rising HCV incidence and high rates of HCV testing and treatment). We modeled the HCV incidence among HIV-diagnosed MSM in Berlin until 2030 (relative to 2015 WHO baseline) under scenarios of DAA scale-up with or without behavior change (among HIV-diagnosed MSM and/or all MSM). Results Continuing current treatment rates will marginally reduce the HCV incidence among HIV-diagnosed MSM in Berlin by 2030. Scaling up DAA treatment rates, beginning in 2018, to 100% of newly diagnosed HCV infections within 3 months of diagnosis and 25% each year of previously diagnosed and untreated HCV infections could reduce the HCV incidence by 61% (95% confidence interval, 55.4%–66.7%) by 2030. The WHO target would likely be achieved by combining DAA scale-up with a 40% reduction in HCV transmission among HIV-diagnosed MSM and a 20% reduction among HIV-undiagnosed or HIV-uninfected MSM. Discussion HCV elimination among HIV-infected MSM in Berlin likely requires combining DAA scale-up with moderately effective behavioral interventions to reduce risk among all MSM.

Materialart: Online-Ressource

ISSN: 0022-1899 , 1537-6613

URL: Article

DOI: 10.1093/infdis/jiz367

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2019

ZDB Id: 1473843-0

In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 49, No. 2 ( 2009-07-15), p. 317-319

Materialart: Online-Ressource

ISSN: 1058-4838 , 1537-6591

URL: Issue

URL: Article

DOI: 10.1086/599186

DOI: 10.1086/600058

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2009

ZDB Id: 2002229-3

In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 63, No. 10 ( 2016-11-15), p. 1320-1324

Materialart: Online-Ressource

ISSN: 1058-4838 , 1537-6591

URL: Article

DOI: 10.1093/cid/ciw567

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2016

ZDB Id: 2002229-3

In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 4, No. 3 ( 2017-07-01)

Kurzfassung: Current hepatitis C virus (HCV) treatment guidelines recommend treating HCV/human immunodeficiency virus (HIV)-coinfected individuals similar to HCV-monoinfected individuals. Recently inferior response rates to direct acting antiviral (DAA) therapy in HCV/HIV coinfection have been reported. Our German hepatitis C cohort (GECCO) cohort data show that coinfected patients with liver cirrhosis are less likely to achieve viral eradication.

Materialart: Online-Ressource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofx158

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2017

ZDB Id: 2757767-3

In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 8, No. Supplement_1 ( 2021-12-04), p. S46-S46

Kurzfassung: Metabolic comorbidities including diabetes (DM) and dyslipidemia pose challenges to the long-term care of people with HIV (PWH). Incidence of cardiovascular disease and DM are reported at higher rates in PWH than the general population. Obesity is broadly prevalent in both the general population and PWH, and higher body mass index (BMI) can contribute to metabolic complications. Here we present longer-term follow up on incidence of DM, hypertension (HTN), BMI categorical shifts, and lipid changes over 144 weeks of blinded treatment from two trials of PWH initiating antiretroviral therapy. Methods We assessed incidence of metabolic complications in adult PWH in Study 1489: bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) vs dolutegravir/abacavir/ lamivudine (DTG/ABC/3TC) and Study 1490: B/F/TAF vs DTG+F/TAF. Treatment-emergent (TE) metabolic comorbidities were defined by standard MedDRA search lists. CDC-defined BMI categories were compared from baseline (BL) to Week 144. Analyses by sex at birth and race were performed, as well as for lipid changes. Results Among 1,274 total participants, median (range) age was 33 years (18-77), 90% men, 33% black. In study 1489, BL prevalence of DM and HTN was 4.5 and 12.1% with TE DM and HTN in B/F/TAF being 0.7% and 10%, and for DTG/ABC/3TC 1.3% and 6.9%, respectively. In study 1490, BL prevalence of DM and HTN was 6.8 and 18.8% with TE DM and HTN in B/F/TAF being 2.1 and 5.8%, and for DTG+F/TAF 2.3 and 6.5%, respectively. BMI shift from Normal to Obese: B/F/TAF 0%, DTG/ABC/3TC 3.2%, p=0.12 (1489) (Table 1); B/F/TAF 2.5%, DTG+F/TAF 2.9% p=1.00 (1490) (Table 2). Subgroup analyses by gender/race showed similar findings for TE DM, HTN, and BMI changes. Median changes from BL fasted lipids were small (Table 1). Table 1§. Studies 1489 and 1490: Metabolic Outcomes from Baseline to Week 144 Table 2±. Shift Table of BMI Category at Week 144 by Baseline BMI Category – Overall Conclusion Through over 144 weeks of follow up, PWH randomized to initiate B/F/TAF, DTG/ABC/3TC or DTG+F/TAF had low rates of incident DM or HTN-related AEs, with no statistically significant differences by treatment group. BMI changes/categorical shifts from BL did not significantly differ by regimen, and no clinically significant change or difference by regimen in lipids were observed. While data are limited by three years of follow up, they are strengthened by randomized study design of three widely used initial ART regimens. Disclosures Eric Daar, MD, Bristol-Myers Squibb (Consultant)Gilead Sciences Inc. (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support)Janssen (Consultant, Advisor or Review Panel member, Research Grant or Support)Merck (Consultant, Advisor or Review Panel member, Research Grant or Support)Teva (Consultant, Advisor or Review Panel member)ViiV Healthcare (Consultant, Advisor or Review Panel member, Research Grant or Support) Chloe Orkin, MD, Gilead Sciences Inc. (Grant/Research Support, Scientific Research Study Investigator, Other Financial or Material Support)Janssen (Research Grant or Support, Other Financial or Material Support)Merck (Research Grant or Support, Other Financial or Material Support)ViiV Healthcare (Research Grant or Support, Other Financial or Material Support) Paul Sax, MD, Gilead Sciences (Consultant, Grant/Research Support)Janssen (Consultant)Merck (Consultant, Research Grant or Support)ViiV (Consultant, Research Grant or Support) Jeffrey L. Stephens, MD, Gilead Sciences Inc. (Scientific Research Study Investigator, Research Grant or Support) Ellen Koenig, MD, Gilead Sciences Inc. (Scientific Research Study Investigator) Amanda Clarke, MD, Gilead Sciences Inc. (Consultant, Scientific Research Study Investigator, Other Financial or Material Support, Conference attendance sponsorship)ViiV Healthcare (Consultant, Other Financial or Material Support, Conference travel sponsorship) Axel Baumgarten, MD, AbbVie (Advisor or Review Panel member, Speaker’s Bureau)Bristol-Myers Squibb (Advisor or Review Panel member, Speaker's Bureau)Gilead Sciences Inc. (Scientific Research Study Investigator, Advisor or Review Panel member, Speaker's Bureau)Janssen (Speaker’s Bureau)Merck (Advisor or Review Panel member) Cynthia Brinson, MD, Abbvie (Scientific Research Study Investigator)BI (Scientific Research Study Investigator)Gilead Sciences Inc. (Scientific Research Study Investigator, Advisor or Review Panel member, Speaker's Bureau, Personal fees)GSK (Scientific Research Study Investigator)Novo Nordisk (Scientific Research Study Investigator)ViiV Healthcare (Scientific Research Study Investigator, Advisor or Review Panel member, Speaker's Bureau) Moti Ramgopal, MD FIDSA, Abbvie (Scientific Research Study Investigator, Speaker's Bureau)Gilead (Consultant, Scientific Research Study Investigator, Speaker's Bureau)Janssen (Consultant, Scientific Research Study Investigator, Research Grant or Support, Speaker's Bureau)Merck (Consultant, Scientific Research Study Investigator)ViiV (Consultant, Scientific Research Study Investigator, Speaker's Bureau) Hailin Huang, PhD, Gilead Sciences Inc. (Employee, Shareholder) Terry Farrow, MD, Gilead Sciences Inc. (Employee, Shareholder) Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) Jason Hindman, PharmD, Gilead Sciences Inc. (Employee, Shareholder) Hal Martin, MD, MPH, Gilead Sciences Inc. (Employee, Shareholder) Kimberly Workowski, MD, Nothing to disclose

Materialart: Online-Ressource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofab466.069

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2021

ZDB Id: 2757767-3

In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)

Kurzfassung: People with HIV (PWH) who are initiated on guidelines-recommended first-line INSTI-based antiretroviral therapy routinely achieve rapid virologic suppression; however, those with a high baseline (BL) HIV-1 RNA and/or low CD4 count may be more challenging to manage in the short- and long-term. To further characterize long-term outcomes over 5 years in select subgroups, we analyzed results from two studies examining B/F/TAF as initial treatment stratified by BL HIV-1 RNA and/or CD4 count. Methods Adults with HIV were randomized to receive blinded initial treatment with B/F/TAF versus dolutegravir [DTG]/abacavir/lamivudine (Study 1489) or DTG+F/TAF (1490) for 144 weeks (W) of blinded treatment followed by an optional switch to open-label B/F/TAF for 96W. We present virologic response (HIV-1 RNA & lt; 50 c/mL, missing=excluded and missing=failure) and study drug-related adverse events (DRAE) from a pooled analysis of participants originally randomized to B/F/TAF who had BL HIV-1 RNA 100,00-400,000 copies(c)/mL, HIV-1 RNA & gt;400,000 c/mL and/or CD4 count & lt; 200 cells/µL through W240. Results 634 adults (median age 32 years, 89% men, 33% Black/African descent, 24% Hispanic/LatinX) originally randomized to B/F/TAF were included for analysis. At BL, 80 participants had a BL CD4 count & lt; 200 cells/µL and 119 participants had HIV-1 RNA & gt;100,000 c/mL, of whom, 20 had HIV-1 RNA & gt;400,000 c/mL. At W240, virologic suppression was high for the low CD4 count and/or high HIV-1 RNA subgroups (Table). No participant in the final resistance analysis developed virologic resistance to any component of B/F/TAF. Across the subgroups, the most common DRAEs were nausea, headache and diarrhea and there were no serious DRAEs. There was only one discontinuation due to a DRAE in the low CD4 count subgroup, and none in the high HIV-1 RNA subgroup. Conclusion Initial treatment with B/F/TAF was safe and efficacious over 5 years of follow-up in people with a high BL HIV-1 RNA and/or low CD4 count. These outcomes provide additional evidence that B/F/TAF is an effective and durable regimen for a broad range of PWH, including those with advanced disease. Disclosures Moti Ramgopal, MD, FACP, FIDSA, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Speakers Bureau|Janssen: Advisor/Consultant|Janssen: Speakers Bureau|Merck: Advisor/Consultant|Merck: Speakers Bureau|ViiV: Advisor/Consultant|ViiV: Speakers Bureau Axel Baumgarten, MD, AbbVie: Honoraria|Gilead Sciences: Honoraria|Janssen: Honoraria|MSD: Honoraria|ViiV: Honoraria Anton Pozniak, MD, FRCP, Gilead: Grant/Research Support|Gilead: Honoraria|Janssen: Grant/Research Support|Janssen: Honoraria|Merck: Honoraria|theratec: Honoraria|ViiV: Grant/Research Support|ViiV: Honoraria Chloe Orkin, MBChB, FRCP, MD, Gilead Sciences: Honoraria|GSK: Honoraria|Janssen: Honoraria|MSD: Honoraria Juan Manuel Tiraboschi, PhD, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|MSD: Advisor/Consultant|MSD: Grant/Research Support|ViiV Healthcare: Advisor/Consultant|ViiV Healthcare: Grant/Research Support Debbie P. Hagins, MD, FAPCR, AAHIVS, Gilead Sciences: Advisor/Consultant|Gilead Sciences: Grant/Research Support|Gilead Sciences: Speakers Bureau|Janssen: Grant/Research Support|Merck: Advisor/Consultant|Merck: Grant/Research Support|ViiV: Advisor/Consultant|ViiV: Grant/Research Support Hailin Huang, PhD, Gilead Sciences, Inc.: Employer|Gilead Sciences, Inc.: Stocks/Bonds Kristin Andreatta, MSc, Gilead Sciences, Inc: Employee of Gilead Sciences|Gilead Sciences, Inc: Stocks/Bonds Nathan Unger, PharmD, AAHIVP, Gilead Sciences: Employee|Gilead Sciences: Stocks/Bonds Jason Hindman, PharmD, MBA, Gilead Sciences: Employee|Gilead Sciences: Stocks/Bonds Hal Martin, MD, Gilead Sciences: employee|Gilead Sciences: Stocks/Bonds Jared Baeten, MD, PhD, Gilead Sciences: Employee|Gilead Sciences: Stocks/Bonds Olayemi Osiyemi, MD, Gilead: Advisor/Consultant|gsk: Advisor/Consultant|viiv: Advisor/Consultant.

Materialart: Online-Ressource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofac492.1082

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2022

ZDB Id: 2757767-3

In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 71, No. 5 ( 2020-08-22), p. 1248-1254

Kurzfassung: Micro-elimination of the hepatitis C virus (HCV) includes treatment in populations at risk of ongoing HCV transmission, such as men who have sex with men (MSM) or people who inject drugs (PWID). We analyzed the HCV reinfection incidence rates of participants in the German hepatitis C cohort (GECCO) and compared our data to previous findings from the interferon era. Methods Patients with HCV reinfections in the multi-centric GECCO cohort were compared to patients in whom no reinfection occurred. The HCV reinfection incidence rate in MSM was also compared to the incidence rate in the interferon era (using data from the European Acquired Immunodeficiency Syndrome Treatment Network [NEAT]). Results Between January 2014 and April 2018, 48 HCV reinfections occurred in 2298 individuals (2%), with 2346 cured HCV episodes. The median time to reinfection was 500 days (range 16–1160) and the overall HCV reinfection incidence rate was 1.89 per 100 person-years (py; 95% confidence interval [CI], 1.41–2.48). In a multivariate analysis, the transmission risk in MSM was the only independent risk factor of HCV reinfection (odds ratio, 39.3; 95% CI, 4.57–334.40; P = .001). The incidence rate in MSM was 9.02 (95% CI, 6.48–12.26) per 100 py, compared to 1.14 per 100 py in PWID (95% CI, .56–2.09). The incidence rate for a first HCV reinfection in MSM was similar in the direct-acting antiviral era, compared to the interferon era, with a hazard ratio of 1.05 (95% CI, .64–1.74; P = .831). Conclusions HCV reinfection remains a frequent finding among MSM in Germany. In addition to behavioral interventions, early HCV treatment and retreatment should be implemented for this subgroup to prevent HCV transmission.

Materialart: Online-Ressource

ISSN: 1058-4838 , 1537-6591

URL: Article

DOI: 10.1093/cid/ciz949

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2020

ZDB Id: 2002229-3

In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 5, No. suppl_1 ( 2018-11-26), p. S760-S761

Kurzfassung: Bictegravir (B), a potent INSTI with a high barrier to resistance, is coformulated with emtricitabine (F) and tenofovir alafenamide (TAF) as the FDA-approved single-tablet regimen B/F/TAF. We report Week 96 results from an ongoing phase 3 study comparing B/F/TAF to coformulated dolutegravir, abacavir, and lamivudine (DTG/ABC/3TC) in treatment-naïve adults living with HIV-1. Primary outcome at W48 demonstrated noninferior virologic responses, similar bone and renal profiles, and no viral resistance. Methods We randomized 1:1 HLA-B*5701-negative adults, without HBV and with estimated glomerular filtration rate (eGFR) ≥50 mL/minute to receive blinded B/F/TAF (50/200/25 mg) or DTG/ABC/3TC (50/600/300 mg) with matching placebos QD. Primary endpoint was proportion with HIV-1 RNA & lt;50 copies/mL at W48 (FDA snapshot), with secondary analyses at W96. Noninferiority was assessed with 95% confidence intervals (CI) (12% margin). Other secondary endpoints were safety (adverse events [AEs], laboratory abnormalities) and predefined analyses of bone mineral density (BMD) and measures of renal function (eGFR, proteinuria). Results A total of 629 adults were randomized/treated (314 B/F/TAF, 315 DTG/ABC/3TC). At W96, B/F/TAF was noninferior to DTG/ABC/3TC: 87.9% vs. 89.8%, respectively, achieved HIV-1 RNA & lt;50 copies/mL (difference −1.9%; 95%CI −6.9% to 3.1%, P = 0.45). In per-protocol analysis, 99.6% on B/F/TAF vs. 98.9% on DTG/ABC/3TC achieved HIV-1 RNA & lt;50 copies/mL (P = 0.33). Most common AEs overall were nausea (11% B/F/TAF, 24% DTG/ABC/3TC, P & lt; 0.001), diarrhea (15%, 16%), and headache (13%, 16%). Through W96, no participant had emergent resistance to study drugs. No participant discontinued B/F/TAF due to AEs; five (2%) discontinued DTG/ABC/3TC due to AEs (one after W48). Treatment-related AEs occurred in 28% B/F/TAF vs. 40% DTG/ABC/3TC (P = 0.002); most common was nausea (6%, 17%. P & lt; 0.001). At W96, mean percentage changes in spine and hip BMD were small and similar between groups (table); median change in eGFR was significantly less with B/F/TAF, while median % changes in proteinuria were similar. Conclusion At W96, B/F/TAF was virologically noninferior to DTG/ABC/3TC, with no viral resistance or safety-related discontinuations. B/F/TAF was well tolerated with less nausea than DTG/ABC/3TC and similar bone and renal safety. Disclosures D. A. Wohl, Gilead: Grant Investigator and Scientific Advisor, Consulting fee and Research grant. Y. Yazdanpanah, AbbVie: Consultant, Consulting fee. Bristol-Myers Squibb: Consultant, Consulting fee. Gilead: Consultant, Consulting fee. MSD: Consultant, Consulting fee. Pfizer: Consultant, Consulting fee. Johnson & Johnson: Consultant, Consulting fee. ViiV Healthcare: Consultant, Consulting fee. A. Baumgarten, AbbVie: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. BMS: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. Gilead: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. Janssen-Cilag: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. MSD: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. ViiV: Consultant and Speaker’s Bureau, Consulting fee and Speaker honorarium. A. Clarke, GSK: Scientific Advisor, Consulting fee. Gilead: Conference attendence, Scientific Advisor and Speaker’s Bureau, Conference attendance support, Consulting fee and Speaker honorarium. BMS: Conference attendence, Conference attendance support. Janssen: Conference attendence, Conference attendance support. M. Thompson, Bristol Myers Squibb: Research Contractor, Research support. ViiV Healthcare: Research Contractor, Research support. C. Brinson, Gilead: Investigator, Scientific Advisor and Speaker’s Bureau, Research support and Speaker honorarium. Theratech: Investigator, Research support. BMS: Investigator, Research support. SlieaGen: Investigator, Research support. GSK ViiV: Consultant, Investigator and Scientific Advisor, Consulting fee, Research support and Speaker honorarium. Daiichi Sankyo: Sub Investigator, Research support. Novo Nordisk: Investigator, Research support. Sanofi: Investigator, Research support. Watson: Investigator, Research support. Salix: Investigator, Research support. Janssen: Investigator, Research support. Roche: Investigator, Research support. Colucid: Investigator, Research support. Eisai: Investigator, Research support. Shionogi: Investigator, Research support. Elcelyx: Investigator, Research support. Sangamo: Sub Investigator, Research support. D. Hagins, GlaxoSmithKline: Scientific Advisor and Speaker’s Bureau, Honoraria and Speaker honorarium. ViiV Healthcare: Scientific Advisor and Speaker’s Bureau, Honoraria and Speaker honorarium. Gilead: Scientific Advisor, Honoraria and Speaker honorarium. Bristol-Myers Squibb: Scientific Advisor and Speaker’s Bureau, Honoraria and Speaker honorarium. M. Ramgopal, Gilead: Grant Investigator, Research grant. A. Antinori, AbbVie: Consultant, Consulting fee. BMS: Consultant and Grant Investigator, Consulting fee and Research grant. Gilead: Consultant and Grant Investigator, Consulting fee and Research grant. Janssen-Cilag: Consultant and Grant Investigator, Consulting fee and Research grant. Merck: Consultant, Consulting fee. ViiV Healthcare: Consultant and Grant Investigator, Consulting fee and Research grant. X. Wei, Gilead: Shareholder, Salary and Stock. K. White, Gilead: Employee and Shareholder, Salary and Stock. S. Collins, Gilead: Employee and Shareholder, Salary and Stock. A. Cheng, Gilead: Employee and Shareholder, Salary and Stock. E. Quirk, Gilead: Employee and Shareholder, Salary and Stock. H. Martin, Gilead: Employee and Shareholder, Salary and Stock.

Materialart: Online-Ressource

ISSN: 2328-8957

URL: Article

DOI: 10.1093/ofid/ofy229.2178

Sprache: Englisch

Verlag: Oxford University Press (OUP)

Publikationsdatum: 2018

ZDB Id: 2757767-3