Cost per care of the first year of direct antiviral agents in the liguria region: A multicenter analysis

Aims: Despite the remarkable efficacy shown in clinical practice, concerns have been raised about the costs associated with direct antiviral agent (DAA) therapy. This article presents the real-life costs for DAA treatment sustained by the Italian National Health Service in the Liguria Region (Northern Italy). Methods: A retrospective analysis of the cost per care sustained for DAA treatment, relating to the period from January 1 to December 31, 2015 in five centers in Liguria was performed. All patients undergoing DAA-based treatments for hepatitis C virus (HCV) infection were enrolled. On-treatment costs included: HCV treatment, laboratory test, outpatient services, attended visits, drugs used for the management of adverse events (erythropoietin, albumin or red blood cell packs) and inpatient service admissions. Results: In total, 327 patients were enrolled. No difference in terms of sustained virologic response (SVR) rate among different treatments was reported. The majority (85.0%) of patients did not report any side effects and only 15 (4.6%) required hospital admission. Forty-two patients (12.8%) required high-cost drugs for the management of adverse events. The overall cost sustained was \u20ac14,744,433. DAA\ub1ribavirin (RBV) accounted for the wide majority of this cost (98.9%; \u20ac14,585,123). Genotype (GT) 1, the most commonly treated GT, was associated with an average cost of \u20ac43,445 per patient. Detailed analysis of the costs for GT 1 showed the treatment based on ritonavir boosted paritaprevir/ombitasvir + dasabuvir\ub1RBV with an average cost of \u20ac24,978 (RBV+) and \u20ac25,448 (RBV 12) per patient was the most cost-effective. The average cost per SVR was \u20ac48,184. Once again, the ritonavir boosted paritaprevir/ ombitasvir + dasabuvir regimen was associated with the lowest cost/SVR (\u20ac25,448/SVR [GT 1b] and similar results for other GTs). Conclusion: Antiviral regimen is the major contributor to costs in the treatment of HCV infection. Appropriate regimen selection could result in a major cost saving, which can be reinvested to allow more patients to be treated

High anti-TNF alfa drugs trough levels are not associated with the occurrence of adverse events in patients with inflammatory bowel disease

Objectives: Up to 40% of inflammatory bowel disease (IBD) patients treated with anti-TNF drugs lose response within 1 year of treatment, therefore requiring drug optimization. Although higher drug trough levels (TLs) are associated with sustained clinical outcomes, there are concerns that they may be associated with a higher risk of adverse events (AEs). The aim was to evaluate the presence of a possible association between drug TLs and the occurrence of AEs in IBD patients treated with anti-TNF drugs. Methods: We retrospectively studied a cohort of 113 IBD patients treated with adalimumab or infliximab, of whom 27 were in combination therapy with immunosuppressants. TLs were measured using a homogeneous mobility shift assay. Results: During a median follow-up of 16\u2009months (range 1-144), we observed 103 AEs occurring in 58 patients. We found no statistically significant difference (p\u2009=\u2009.21) in median TLs between patients who did 6.7\u2009mcg/mL; range 0.0-36.2) or did not (7.7\u2009mcg/mL; range 0.0-20.7) experience an AE. No difference was observed in the rate of AEs between patients in mono- or combination therapy (p\u2009=\u2009.38), as well as between elderly (i.e., >65\u2009years) and younger patients (p\u2009=\u2009.32). Considering a TL cutoff of 7\u2009mcg/mL for infliximab and 12\u2009mcg/mL for adalimumab, or even double these TL values, we observed no statistically significant difference in the rate of AEs occurrence. Conclusion: Our study suggests that, when clinically required, anti-TNF drug dosage may be increased without particular concerns regarding the risk of AEs occurrence in IBD patients, even in patients on combination therapy and elderly ones

Low serum trough levels are associated with post-surgical recurrence in Crohn's disease patients undergoing prophylaxis with adalimumab.

none9siBACKGROUND: Whether therapeutic drug monitoring of biologic therapy can predict the efficacy of adalimumab to prevent postoperative Crohn's disease recurrence is unknown. AIM: To investigate whether adalimumab trough levels and anti-adalimumab antibodies correlate with endoscopic and clinical outcomes in a series of patients treated with prophylactic adalimumab monotherapy after resective surgery. METHODS: Post hoc analysis of a randomized, mesalamine-controlled trial. Adalimumab trough levels and antibodies were analysed every 8 weeks for 2 years using an homogeneous mobility shift assay. RESULTS: At two years, 1/6 patient had clinical recurrence and 1/6 patient had endoscopic and clinical recurrence. At baseline (9.5 vs. 14.4 mcg/mL) and during follow-up [7.5 (4.4-9.8) vs. 13.9 (8.9-23.6)mcg/mL, p<0.01], median adalimumab trough levels in patients with clinical or endoscopic recurrence were lower than in those who maintained remission. Persistent antibodies-against-adalimumab were detected in the patient with both endoscopic and clinical recurrence. CONCLUSION: Measurement of adalimumab trough levels and anti-adalimumab antibodies after surgery could be useful to further reduce postoperative recurrence.noneBodini, Giorgia; Savarino, Vincenzo; Peyrin-Biroulet, Laurent; de Cassan, Chiara; Dulbecco, Pietro; Baldissarro, Isabella; Fazio, Valentina; Giambruno, Elisa; Savarino, EdoardoBodini, Giorgia; Savarino, Vincenzo; Peyrin Biroulet, Laurent; DE CASSAN, Chiara; Dulbecco, Pietro; Baldissarro, Isabella; Fazio, Valentina; Giambruno, Elisa; Savarino, EDOARDO VINCENZ

Therapeutic drug monitoring in Crohn's disease patients treated with anti-TNF: a comparison of two techniques

Therapeutic drug monitoring is a useful clinical decision aid in managing patients with inflammatory bowel disease treated with anti-tumor necrosis factor (anti-TNF). Various techniques are available to evaluate drug trough levels, and among these a point-of-care (POC) method has been proposed to overcome the limitations inherent to other methodologies. In this study we aimed to evaluate the capability of POC to discriminate between relapse and remission disease phases, and to assess the concordance of the POC and homogeneous mobility shift assay (HMSA) results

Comparison of Two Different Techniques to Assess Adalimumab Trough Levels in Patients with Crohn's Disease.

Background &amp; Aims: Loss of response to anti-tumor necrosis factor (TNF) drugs in patients with inflammatory bowel disease is likely due to low drug serum levels, and dosing anti-TNF drug concentrations may improve patients\u2019 outcome. However, there are limited data on the diagnostic accuracy and utility of currently available assays for measuring anti-TNF levels. In this study, our aim was to compare serum adalimumab concentrations with two different techniques. Methods: We assessed serum adalimumab concentrations in 23 patients with Crohn\u2019s disease during a 96-week follow-up period. Adalimumab trough levels were assessed using a sandwich principle-based enzyme-linked immunosorbent assay (ELISA) and a homogeneous mobility shift assay (HMSA). Results: At week 48, adalimumab trough levels were significantly lower in patients who experienced relapse compared to patients in remission, using both ELISA and HMSA methods: 4.8 mcg/mL (2.4-7.2 mcg/mL) vs. 7.5 mcg/mL (6.6-8.4 mcg/mL) (P=0.01) and 6.5 mcg/mL (3-10 mcg/mL) vs. 11.6 mcg/mL (7-16.2 mcg/ ml) (P=0.004), respectively. Similar results were obtained at week 96: 5.9 mcg/mL (3.3-8.5 mcg/mL) vs. 12.8 mcg/mL (9.4-16.2 mcg/mL) (P=0.001) and 4.1 mcg/mL (1.6-6.6 mcg/mL) vs. 7.5 mcg/mL (5.7-9.3 mcg/mL) (P=0.009), respectively. There was a significant correlation between ELISA and HMSA adalimumab trough levels at both 48 (r = 0.691, P=0.0003) and 96 week (r = 0.822, P=0.0001). Conclusions: ELISA and HMSA assays are accurate methods to assess adalimumab trough levels in patients with Crohn\u2019s disease and those who experience loss of response. The preferential use of one of the two techniques should be based on local availability and physicians\u2019 experience