Real-world effectiveness of sofosbuvir/velpatasvir for the treatment of hepatitis C virus in prison settings

Plain language summary Achievement of elimination of HCV as a major public health threat requires focus on vulnerable populations such as people in prison. The prison population is at high risk of HCV infection but their treatment is complicated by social issues such as mental health disorders and drug use. Simple and effective treatment regimens are required to increase access to treatment and improve cure rates. This real-world analysis across Europe and Canada analyzed data from 20 prison populations. HCV-infected individuals were treated with sofosbuvir/velpatasvir, a once daily treatment which requires minimal monitoring. This regimen achieved high cure rates in the prison population despite the existence of complicating social issues. Background: People in prison are at high risk of hepatitis C virus (HCV) infection and often have a history of injection drug use and mental health disorders. Simple test-and-treat regimens which require minimal monitoring are critical. Methods: This integrated real-world analysis evaluated the effectiveness of once daily sofosbuvir/velpatasvir (SOF/VEL) in 20 prison cohorts across Europe and Canada. The primary outcome was sustained virological response (SVR) in the effectiveness population (EP), defined as patients with a valid SVR status. Secondary outcomes were reasons for not achieving SVR, adherence and time between HCV RNA diagnosis and SOF/VEL treatment. Results: Overall, 526 people in prison were included with 98.9% SVR achieved in the EP (n = 442). Cure rates were not compromised by drug use or existence of mental health disorders. Conclusion: SOF/VEL for 12 weeks is highly successful in prison settings and enables the implementation of a simple treatment algorithm in line with guideline recommendations and test-and-treat strategies.

Does Angiotensin II receptor blockers increase the risk of SARS-CoV-2 infection? A real-life experience.

OBJECTIVE: Since the start of the COVID-19 pandemic, millions of people have been infected with thousands of deaths. Few data regarding factors that increase the risk of infection are available. Our study aimed to evaluate all people living in retirement homes (PLRNH) and identify factors that could increase infection risk in a close community. MATERIALS AND METHODS: We conducted a retrospective study enrolling all PLRNH, where at least one SARS-CoV-2 infected person was present. Variables were compared with Student's t-test or Pearson chi-square test as appropriate. Uni- and multivariate analyses were conducted to evaluate variables' influence on the infection. RESULTS: We included 452 PLRNH; 144 (31.7%) were male, with a mean age of 82.2±8.6 years. People with a positive swab for SARS-CoV-2 were 306 (67.4%). A significant difference between SARS-CoV-2 infected and not infected was observed in the percentage of those receiving chronic treatment with Angiotensin II receptor blockers (ARBs) (18.6% vs. 9.5%, p=0.012). On the contrary, there was no difference in the proportion of those receiving ACE inhibitors (ACE-I) (21.2% vs. 23.6%, p=0.562). At multivariate analysis, people with mental illness and cancer had an increased risk of being infected. Furthermore, receiving ARBs as a chronic treatment was an independent predictor of infection risk [OR 1.95 (95% CI 1.03-3.72) p=0.041]. CONCLUSIONS: Our data suggest that, in close communities, such as retirement nursing homes, the receipt of ARBs increased the risk of acquiring SARS-CoV-2 infection. However, before changing an important chronic treatment in a fragile population, such as the elderly living in retirement nursing homes, clinicians should carefully evaluate the risk-benefit ratio.

HCV elimination in active PWID: SOF/VEL as a simple tool to implement a test and treat approach in this vulnerable population

Background: The treatment of high priority populations, including patients actively using intravenous drugs (active PWID), must be prioritized to accomplish the WHO HCV elimination goals by 2030. Simplification of the treatment cascade is key to reaching this goal, even more so in the COVID-19 era Sofosbuvir/velpatasvir (SOF/VEL) is a protease inhibitor-free, pangenotypic, panfibrotic, single duration, single tablet regimen, to be taken without regards to food and with limited drug-drug interactions This real-world analysis evaluates SOF/VEL as a simple strategy to implement a testand- treat approach in HCV-infected active PWID Methods: Adult active PWID treated for HCV with 12 weeks SOF/VEL in different clinical settings were included from 25 cohorts in 6 countries Patients with a history of decompensation or prior NS5A-inhibitor exposure were excluded The endpoints were HCV cure (undetectable HCV RNA ≥12 after the end of therapy, SVR12) and time-to-treatment (TT) between most recent HCV RNA measurement and SOF/VEL treatment start Results: Analysis included 340 patients, mean age 44±10years, 84% male, 15% compensated cirrhotic (CC) and 8% treatment-experienced, with 43% genotype (GT) 1 and 41% GT3 73% of patients were diagnosed with a mental disorder, 27% were homeless and 21% incarcerated Of patients with TT available (n=334), 10% were treated the same day of diagnosis, 16% within 1 week, 39% within 1 month, and 69% within 3 months Treatment adherence below 90% was observed in 24 patients (8%) SVR12 is available for 254 patients (75%), as non-virological or unknown cause of failure was documented in 86 patients (25%), 79% due to lost-to-follow-up (LTFU) SVR12 was 98% overall (249/254), 98% (80/82) in non-cirrhotic and 95% (20/21) in CC patients Active PWID with mental disorders showed 97% SVR12 (181/186) Of active PWID with GT3 infection, 96% (104/180) were cured, including 95% (20/21) of those with CC Of 31 patients starting treatment within 1 week of diagnosis, all achieved SVR12 compared to 126/129 (98%) starting within 3 months of diagnosis Conclusion: SOF/VEL is a simple HCV treatment resulting in high cure rates in active PWID, including patients with multiple complicating factors LTFU remains a challenge in this population The simplicity of the SOF/VEL approach allowing for shortening of the patient care cascade and rapid treatment starts with high cure rates may help address this important issue.

Routine laboratory tests alterations in relation with the severity of coronavirus disease 2019 (COVID-19)

Introduction. Coronavirus disease 19 (COVID-19) is the greatest pandemic in modern history. The aim of this study was to investigate the alteration and prognostic potential of routine blood tests in a series of consecutive Italian patients with COVID-19. Methods. Clinical data and routine laboratory tests of a consecutive series of 62 COVID-19 patients treated in the Units of Infectious and Respiratory Diseases of the University of Sassari from 15 March through 30 April 2020, have been retrospectively collected. Differences in laboratory tests performed at hospital admission between COVID-19 survivors and non survivors were statistically searched and analyzed. Results. Patients in non-survivors group had higher number of WBCs (median: 9.16 x109L;IQR: 6.29-13.07 x109L vs 6.37 x109L;IQR: 4.95-9.04 x109L, p=0.037), neutrophils (mean: 9.2±6.0 x109L vs 5.4±2.7 x109L, p=0.001), and lower lymphocytes number (median: 0.6 x109L;IQR: 0.6-0.85 x109L vs 1.0 x109L;IQR: 0.7-1.2 x109L, p=0.013). In addition, non-survivors showed lower albumin (median: 3.2 g/dL;IQR: 2.9-3.4 g/dL vs 3.5 g/dL;IQR: 3.0-3.9 g/dL, p=0.035), and increased PCR/albumin ratio (median: 3.65;IQR: 2.17-6.86 vs 1.56;IQR: 0.64-4.36, p=0.035) and De Ritis ratio (median: 1.14;IQR: 0.89-1.48 vs 1.73;IQR: 1.29-2.27, p=0.002). Increased levels of LDH (median: 359 IU/L;IQR: 259-504 vs 273 IU/L;IQR: 197-356 IU/L, p=0.017), procalcitonin (median: 0.28 ng/mL;IQR: 0.19-0.52 ng/mL vs 0.07 ng/mL;IQR: 0.03-0.17 ng/mL, p=0.0006) and troponin (median: 0.181 ng/mL;IQR: 0.068-0.193 ng/mL vs 0.004 ng/mL;IQR: 0.000-0.017 ng/mL, p=0.002) has been found in nonsurvivors. In ROC curve analysis the better performing indexes were troponin, with a threshold of 0.037 ng/mL, 86% sensitivity and 100% specificity (AUC=0.908, 95% CI 0.701 to 0.989, p<0.001) and procalcitonin with a threshold of 0.18 ng/mL, 79% sensitivity and 79% specificity (AUC=0.807, 95% CI 0.681 to 0.900, p<0.001). Conclusions. Differences in routine laboratory test alterations between COVID-19 survivors and nonsurvivors have been detected;troponin and procalcitonin were the biomarkers which showed the highest prognostic abilities in our study.