Publications by authors named "Pamela Belperio"

Article Synopsis
  • In March 2020, the White House Coronavirus Task Force identified the need for expert treatment guidelines for managing COVID-19 due to its life-threatening nature and lack of known effective treatments.
  • The NIH was tasked with quickly assembling a panel of experts to create "living" guidelines, which would be regularly updated as new information about the virus emerged.
  • The article reflects on the Panel's experiences over four years, summarizes its final recommendations, discusses ongoing challenges, and notes that the responsibility for COVID-19 guidelines will now shift to professional organizations following the end of the public health emergency.
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Background: Uptake and access to HIV preexposure prophylaxis (PrEP) is key to reducing incident HIV infections. Pharmacists are one of the most accessible health care professionals in the United States and are well suited to address this need.

Observations: We describe a model of care at the Veterans Affairs Greater Los Angeles Healthcare System in which clinical pharmacist practitioners developed and implemented a pharmacy-led PrEP clinic colocated within an infectious disease clinic.

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Article Synopsis
  • The NIH COVID-19 Treatment Guidelines were initiated in March 2020 following a request from the White House Coronavirus Task Force, leading to the establishment of a diverse panel that included experts from multiple sectors to create and update treatment recommendations.
  • Within two weeks, the initial guidelines were published online, but the rapid evolution of COVID-19 treatment data necessitated 24 updates in the first year, reflecting the dynamic nature of clinical research.
  • Key lessons learned from this process include the importance of accessible, credible guidelines, the value of collaboration among various health entities, the necessity for well-designed clinical trials, and the need for frequent updates to adapt to new evidence.
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Introduction: Although opioid use disorder (OUD) is common in patients with cirrhosis, it is unclear how medication treatment for OUD (MOUD) is used in this population. We aimed to assess the factors associated with MOUD and mortality in a cohort of Veterans with cirrhosis and OUD.

Methods: Within the Veterans Health Administration Corporate Data Warehouse, we developed a cohort of Veterans with cirrhosis and active OUD, using 2 outpatient or 1 inpatient International Classification of Diseases, ninth revision codes from 2011 to 2015 to define each condition.

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In the United States, the efficacy and safety of convalescent plasma for treating coronavirus disease 2019 (COVID-19) is currently being tested in randomized placebo-controlled clinical trials. Treatment of individual patients with COVID-19 with convalescent plasma outside such trials is also now permitted through U.S.

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Article Synopsis
  • There is a mistake in Figure 1 of the original article.
  • The error could affect the interpretation of the data presented.
  • Corrections should be made to ensure clarity and accuracy in the publication.
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This study describes trends in the incidence of hepatocellular carcinoma within the Veterans Health Administration from 2002 to 2018 before and after widespread direct-acting anti–hepatitis C virus (HCV) treatment.

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Introduction: More than 70 million people are estimated to be infected with hepatitis C virus globally. Glecaprevir/pibrentasvir is a widely used treatment and has recently been approved for an 8-week regimen for treatment-naïve patients with compensated cirrhosis in Europe and the USA, who would previously have received glecaprevir/pibrentasvir for 12 weeks. This label update was based on the EXPEDITION-8 study, which included 343 treatment-naïve patients with compensated cirrhosis.

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Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) provides a needed hepatitis C virus (HCV) antiviral option for direct-acting antiviral (DAA)-experienced patients. We evaluated the effectiveness of SOF/VEL/VOX for 12 weeks in DAA-experienced patients with genotype 1-4 treated in clinical practice. In this observational cohort analysis from the Veterans Affairs' Clinical Case Registry, 573 DAA-experienced patients initiating SOF/VEL/VOX were included: 490 genotype 1, 20 genotype 2, 51 genotype 3 and 12 genotype 4.

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Although direct-acting antivirals (DAAs) for chronic hepatitis C virus (HCV) infection are highly efficacious and safe, treatment initiation is often limited in patients with neuropsychiatric disorders due to concerns over reduced treatment adherence and drug-drug interactions. Here, we report adherence, efficacy, safety and patient-reported outcomes (PROs) from an integrated analysis of registrational studies using the pangenotypic DAA regimen of glecaprevir and pibrentasvir (G/P). Patients with chronic HCV genotypes 1-6 infection with compensated liver disease (with or without cirrhosis) receiving G/P for 8, 12 or 16 weeks were included in this analysis.

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Background & Aim: Understanding the real-world effectiveness of all-oral hepatitis C virus (HCV) regimens informs treatment decisions. We evaluated the effectiveness of daclatasvir + sofosbuvir ± ribavirin (DCV + SOF ± RBV) and velpatasvir/sofosbuvir (VEL/SOF) ± RBV in patients with genotype 2 and genotype 3 infection treated in routine practice.

Methods: This observational analysis was carried out in an intent-to-treat cohort of patients with HCV genotype 2 and genotype 3.

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In direct acting antiviral (DAA)-treated HCV genotype 1, the sustained virologic response rate with the ∆G/∆G genotype of IFNL4 rs368234815 (86.8%) was significantly lower than with ∆G/TT (95.9%, P = 0.

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The Department of Veterans Affairs (VA) has made significant progress in treating hepatitis C virus, experiencing more than a 75% reduction in veterans remaining to be treated since the availability of oral direct-acting antivirals. Hepatitis C Innovation Teams use lean process improvement and system redesign, resulting in practice models that address gaps in care. The key to success is creative improvements in veteran access to providers, including expanded use of nonphysician providers, video telehealth, and electronic technologies.

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Unlabelled: The impact of sustained virologic response (SVR) on mortality after direct-acting antiviral (DAA) treatment is not well documented in patients without advanced liver disease and affects access to treatment. This study evaluated the impact of SVR achieved with interferon-free DAA treatment on all-cause mortality in hepatitis C virus-infected patients without advanced liver disease. This observational cohort analysis was comprised of 103,346 genotype 1, 2, and 3, hepatitis C virus-monoinfected patients without advanced liver disease, defined by FIB-4 ≤3.

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Background: Direct-acting antiviral (DAA) therapy for chronic hepatitis C virus (HCV) infection might pose a risk for hepatitis B virus (HBV) reactivation in patients coinfected with chronic or resolved HBV infection. The need for HBV antiviral prophylaxis during DAA treatment remains controversial. We aimed to analyse the absolute risk of HBV reactivation in patients with active or resolved HBV infection treated with DAAs for HCV infection.

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The U.S. Department of Veterans Affairs (VA) is the nation's largest care provider for hepatitis C virus (HCV)-infected patients and is uniquely suited to inform national efforts to eliminate HCV.

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The impact of sustained virologic response (SVR) on mortality after direct-acting antiviral treatment is not well documented. This study evaluated the impact of direct-acting antiviral-induced SVR on all-cause mortality and on incident hepatocellular carcinoma (HCC) in 15,059 hepatitis C virus-infected patients with advanced liver disease defined by a FIB-4 >3.25.

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Background: Veterans are disproportionately affected by human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV). Homeless veterans are at particularly high risk for HIV, HCV, and HBV due to a variety of overlapping risk factors, including high rates of mental health disorders and substance use disorders. The prevalence of HIV, HCV, and HBV among homeless veterans nationally is currently unknown.

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Unlabelled: Reactivation of hepatitis B virus (HBV) has been reported in hepatitis C virus-infected individuals receiving direct-acting antiviral (DAA) therapy. The overall risk among patients with current or prior HBV infection in the context of DAA treatment is unknown. The aim of this evaluation was to identify and characterize HBV reactivation among veterans treated with oral DAA therapy.

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Background.: Large cohorts are needed to assess human immunodeficiency virus (HIV)/hepatitis C virus (HCV) real-world treatment outcomes. We examined the effectiveness of ledipasvir/sofosbuvir with or without ribavirin (LDV/SOF ± RBV) and ombitasvir/ paritaprevir/ritonavir plus dasabuvir (OPrD) ± RBV in HIV/HCV genotype 1 (GT1)-coinfected patients initiating HCV therapy in clinical practice.

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The Veterans Health Administration (VHA) is the largest provider of hepatitis C virus (HCV) care nationally and provides health care to >200 000 homeless veterans each year. We used the VHA's Corporate Data Warehouse and HCV Clinical Case Registry to evaluate engagement in the HCV care cascade among homeless and nonhomeless veterans in VHA care in 2015. We estimated that, among 242 740 homeless veterans in care and 5 424 712 nonhomeless veterans in care, 144 964 (13.

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Background: Predictors of sustained virological response (SVR) to all-oral HCV regimens can inform nuanced treatment decisions. We evaluated effectiveness and identified predictors of SVR for ledipasvir/sofosbuvir ± ribavirin (LDV/SOF ±RBV) and ombitasvir/paritaprevir/ritonavir + dasabuvir (OPrD) ±RBV in patients treated in routine practice.

Methods: Observational, intent-to-treat cohort of 21,142 genotype-1 patients initiating 8 or 12 weeks of LDV/SOF ±RBV or 12 weeks of OPrD ±RBV at any Veterans Affairs facility.

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