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Sulkowski M.S.,Johns Hopkins University | Eron O.J.,University of North Carolina at Chapel Hill | Wyles D.,University of California at San Diego | Trinh R.,AbbVie | And 21 more authors.
JAMA - Journal of the American Medical Association | Year: 2015

IMPORTANCE: Patients co-infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV) are at high risk for liver disease progression. However, interferon-based treatments for HCV infection have significant toxicities, limiting treatment uptake. OBJECTIVE: To assess the all-oral 3 direct-acting antiviral (3D) regimen of ombitasvir, paritaprevir (co-dosed with ritonavir [paritaprevir/r]), dasabuvir, and ribavirin in HCV genotype 1-infected adults with HIV-1 co-infection, including patients with cirrhosis. DESIGN, SETTING, AND PARTICIPANTS: TURQUOISE-I is a randomized, open-label study. Part 1a of this pilot study was conducted at 17 sites in the United States and Puerto Rico between September 2013 and August 2014 and included 63 patients with HCV genotype 1 and HIV-1 co-infection who were HCV treatment-naive or had history of prior treatment failure with peginterferon plus ribavirin therapy. The study allowed enrollment of patients, including those with cirrhosis, with a CD4+ count of 200/mm3 or greater or CD4+ percentage of 14% or more and plasma HIV-1 RNA suppressed while taking a stable atazanavir- or raltegravir-inclusive antiretroviral regimen. INTERVENTIONS: Ombitasvir/paritaprevir/r, dasabuvir, and ribavirin for 12 or 24 weeks of treatment as randomized. MAIN OUTCOMES AND MEASURES: The primary assessmentwas the proportion of patients with sustained virologic response (HCV RNA <25 IU/mL) at posttreatment week 12 (SVR12). RESULTS: Among patients receiving 12 or 24 weeks of 3D and ribavirin, SVR12 was achieved by 29 of 31 (94%; 95% CI, 79%-98%) and 29 of 32 patients (91%; 95% CI, 76%-97%), respectively. Of the 5 patients who did not achieve SVR, 1 withdrew consent, 2 had confirmed virologic relapse or breakthrough, and 2 patients had clinical history and phylogenetic evidence consistent with HCV reinfection. The most common treatment-emergent adverse events were fatigue (48%), insomnia (19%), nausea (18%), and headache (16%). Adverse events were generally mild, with none reported as serious or leading to discontinuation. No patient had a confirmed HIV-1 breakthrough of 200 copies/mL or greater during treatment. CONCLUSIONS AND RELEVANCE: In this open-label, randomized uncontrolled study, treatment with the all-oral, interferon-free 3D-plus-ribavirin regimen resulted in high SVR rates among patients co-infected with HCV genotype 1 and HIV-1 whether treated for 12 or 24 weeks. Further phase 3 studies of this regimen are warranted in patients with co-infection. Copyright 2015 American Medical Association. All rights reserved. Source


Ward D.,DuPont Company | Slim J.,St Michaels Medical Center
Journal of the International Association of Providers of AIDS Care | Year: 2013

Nevirapine (NVP) was the first nonnucleoside reverse transcriptase inhibitor (NNRTI) approved for the treatment of HIV infection. NVP can provide safe and efficacious viral suppression for treatment-naive patients and for virologically controlled patients "switching" from other NNRTI or protease inhibitor-based regimens. Formulations allowing once-daily dosing of antiretrovirals can significantly improve regimen adherence, which is important for maintaining virologic control, especially for NNRTI-based regimens with low barriers for genetic resistance. Randomized and controlled clinical trials have established the clinical noninferiority of a new, extended-release formulation (XR) of NVP, in both treatment-naive (VERxVE) and treatment-experienced patients (TRANxITION), where patients already stable on the immediate-release formulation of NVP were safely transitioned directly to NVP XR. As a potentially more convenient once-daily option, NVP XR may improve adherence and reduce the risk of mutant viruses, attendant virologic failure, and the spread of drug resistance. © 2013 The Author(s). Source


Slim J.,St Michaels Medical Center
Infectious disease clinics of North America | Year: 2012

This article focuses on the adverse effects of hepatitis C therapy, which includes pegylated interferon alfa-2a or -2b with ribavirin. The hepatitis C virus provider should remain cognizant of the various organ systems that can be affected, which adverse effects should be addressed with the help of an expert, and the presentation of symptoms as they occur throughout the course of therapy. A systems-based approach should help to characterize the nature of the adverse effects that patients experience, and also to determine when patients should be further investigated by a consultant. Copyright © 2012 Elsevier Inc. All rights reserved. Source


Shah P.,St Josephs Regional Medical Center | Bajaj S.,St Michaels Medical Center | Shamoon F.,St Michaels Medical Center
Texas Heart Institute Journal | Year: 2016

Aortic dissection, a rare sequela of percutaneous coronary intervention, can be fatal when it is not recognized and treated promptly. Treatment varies from conservative management to invasive aortic repair and revascularization. We report the cases of 2 patients whose aortic dissection was caused by percutaneous coronary intervention. In addition, we present detailed analyses of 86 previously reported cases. Aortic dissection was most often seen during intervention to the right coronary artery (in 76.7% of instances). The 2 most frequently reported causes were catheter trauma (in 54% of cases) and balloon inflation (in 23.8%). The overall mortality rate was 7.1%. We conclude that most patients can be treated conservatively or by means of stenting alone, with no need for surgical intervention. © 2016 by the Texas Heart® Institute, Houston. Source


Slim J.,St Michaels Medical Center | Afridi M.S.,St Michaels Medical Center
Infectious Disease Clinics of North America | Year: 2012

This article focuses on the adverse effects of hepatitis C therapy, which includes pegylated interferon alfa-2a or -2b with ribavirin. The hepatitis C virus provider should remain cognizant of the various organ systems that can be affected, which adverse effects should be addressed with the help of an expert, and the presentation of symptoms as they occur throughout the course of therapy. A systems-based approach should help to characterize the nature of the adverse effects that patients experience, and also to determine when patients should be further investigated by a consultant. © 2012 Elsevier Inc. Source

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