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- Eron, Joseph J., et al.
(författare)
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Week 96 efficacy and safety results of the phase 3, randomized EMERALD trial to evaluate switching from boosted-protease inhibitors plus emtricitabine/tenofovir disoproxil fumarate regimens to the once daily, single-tablet regimen of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in treatment-experienced, virologically-suppressed adults living with HIV-1
- 2019
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Ingår i: Antiviral Research. - : Elsevier BV. - 0166-3542 .- 1872-9096. ; 170
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Tidskriftsartikel (refereegranskat)abstract
- © 2019 The Authors Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) 800/150/200/10 mg was investigated through 96 weeks in EMERALD (NCT02269917). Virologically-suppressed, HIV-1-positive treatment-experienced adults (previous non-darunavir virologic failure [VF] allowed) were randomized (2:1) to D/C/F/TAF or boosted protease inhibitor (PI) plus emtricitabine/tenofovir-disoproxil-fumarate (F/TDF) over 48 weeks. At week 52 participants in the boosted PI arm were offered switch to D/C/F/TAF (late-switch, 44 weeks D/C/F/TAF exposure). All participants were followed on D/C/F/TAF until week 96. Efficacy endpoints were percentage cumulative protocol-defined virologic rebound (PDVR; confirmed viral load [VL] ≥50 copies/mL) and VL < 50 copies/mL (virologic suppression) and ≥50 copies/mL (VF) (FDA-snapshot analysis). Of 1141 randomized patients, 1080 continued in the extension phase. Few patients had PDVR (D/C/F/TAF: 3.1%, 24/763 cumulative through week 96; late-switch: 2.3%, 8/352 week 52–96). Week 96 virologic suppression was 90.7% (692/763) (D/C/F/TAF) and 93.8% (330/352) (late-switch). VF was 1.2% and 1.7%, respectively. No darunavir, primary PI, tenofovir or emtricitabine resistance-associated mutations were observed post-baseline. No patients discontinued for efficacy-related reasons. Few discontinued due to adverse events (2% D/C/F/TAF arm). Improved renal and bone parameters were maintained in the D/C/F/TAF arm and observed in the late-switch arm, with small increases in total cholesterol/high-density-lipoprotein-cholesterol ratio. A study limitation was the lack of a control arm in the week 96 analysis. Through 96 weeks, D/C/F/TAF resulted in low PDVR rates, high virologic suppression rates, very few VFs, and no resistance development. Late-switch results were consistent with D/C/F/TAF week 48 results. EMERALD week 96 results confirm the efficacy, high genetic barrier to resistance and safety benefits of D/C/F/TAF.
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| 4. |
- Babiker, ZOE, et al.
(författare)
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Extreme elevation of ferritin and creatine kinase in primary infection with HIV-1
- 2015
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Ingår i: International journal of STD & AIDS. - : SAGE Publications. - 1758-1052 .- 0956-4624. ; 26:1, s. 68-71
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Tidskriftsartikel (refereegranskat)abstract
- The diagnosis of primary HIV-1 infection can be challenging, especially in the absence of reported risks or when presenting features are unusual and uncommon. We report an atypical case of primary HIV-1 infection with HIV-1 subtype C in a 61-year old Caucasian man who presented with extreme hyperferritinaemia without iron overload and marked elevation of serum creatine kinase without rhabdomyolysis. In view of his symptomatic seroconversion and low baseline CD4+ T-lymphocyte count, the patient was treated promptly with combination antiretroviral therapy. Subsequently, he made good clinical improvement on treatment and no opportunistic infections were diagnosed at presentation or as part of a later immune reconstitution syndrome. This novel case highlights the importance of clinical suspicion of HIV and suggests that primary HIV-1 infection should be considered in patients presenting with severe hyperferritinaemia or markedly elevated creatine kinase levels. Further studies are required to explain the causative biological mechanisms underlying this rare presentation.
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- Leblebicioglu, Hakan, et al.
(författare)
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Availability of hepatitis C diagnostics and therapeutics in European and Eurasia countries
- 2018
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Ingår i: Antiviral Research. - Amsterdam, Netherlands : Elsevier. - 0166-3542 .- 1872-9096. ; 150, s. 9-14
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Treatment with direct acting antiviral agents (DAAs) has provided sustained virological response rates in >95% of patients with chronic hepatitis C virus (HCV) infection. However treatment is costly and market access, reimbursement and governmental restrictions differ among countries. We aimed to analyze these differences among European and Eurasian countries.METHODS: A survey including 20-item questionnaire was sent to experts in viral hepatitis. Countries were evaluated according to their income categories by the World Bank stratification.RESULTS: Experts from 26 countries responded to the survey. As of May 2016, HCV prevalence was reported as low (≤1%) in Croatia, Czech Republic, Denmark, France, Germany, Hungary, the Netherlands, Portugal, Slovenia, Spain, Sweden, UK; intermediate (1-4%) in Azerbaijan, Bosnia and Herzegovina, Italy, Kosovo, Greece, Kazakhstan, Romania, Russia, Serbia and high in Georgia (6.7%). All countries had national guidelines except Albania, Kosovo, Serbia, Tunisia, and UK. Transient elastography was available in all countries, but reimbursed in 61%. HCV-RNA was reimbursed in 81%. PegIFN/RBV was reimbursed in 54% of the countries. No DAAs were available in four countries: Kazakhstan, Kosovo, Serbia, and Tunisia. In others, at least one DAA combination with either PegIFN/RBV or another DAA was available. In Germany and the Netherlands all DAAs were reimbursed without restrictions: Sofosbuvir and sofosbuvir/ledipasvir were free of charge in Georgia.CONCLUSION: Prevalence of HCV is relatively higher in lower-middle and upper-middle income countries. DAAs are not available or reimbursed in many Eurasia and European countries. Effective screening and access to care are essential for reducing liver-related morbidity and mortality.
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- Wingfield, T, et al.
(författare)
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HIV diagnoses are in our hands
- 2014
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Ingår i: British journal of nursing (Mark Allen Publishing). - : Mark Allen Group. - 0966-0461 .- 2052-2819. ; 23:2, s. 90-
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
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