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11. Progression of the FIB-4 index among patients with chronic HCV infection and early liver disease

Author

Krassenburg, Lisette A P, primary, Maan, Raoel, additional, Puenpatom, Amy, additional, Erler, Nicole S, additional, Welsch, Christoph, additional, van Hees, Stijn, additional, Cerrhoci, Orlando, additional, Vermehren, Johannes, additional, de Knegt, Robert J, additional, Hansen, Bettina E, additional, Zeuzem, Stefan, additional, Vanwolleghem, Thomas, additional, Janssen, Harry L A, additional, de Man, Robert A, additional, Feld, Jordan J, additional, and van der Meer, Adriaan J, additional

Published
2023
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13. Impact of Molnupiravir Treatment on Patient-Reported Coronavirus Disease 2019 (COVID-19) Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial

Author

Guan, Yanfen, primary, Puenpatom, Amy, additional, Johnson, Matthew G, additional, Zhang, Ying, additional, Zhao, Yujie, additional, Surber, Joseph, additional, Weinberg, Aaron, additional, Brotons, Carlos, additional, Kozlov, Roman, additional, Lopez, Rudy, additional, Coetzee, Kathleen, additional, Santiaguel, Joel, additional, Du, Jiejun, additional, Williams-Diaz, Angela, additional, Brown, Michelle, additional, Paschke, Amanda, additional, De Anda, Carisa, additional, and Norquist, Josephine M, additional

Published
2023
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15. Progression of the FIB-4 index among patients with chronic HCV infection and early liver disease

Author

Krassenburg, Lisette A.P., Maan, Raoel, Puenpatom, Amy, Erler, Nicole S., Welsch, Christoph, van Hees, Stijn, Cerrhoci, Orlando, Vermehren, Johannes, de Knegt, Robert J., Hansen, Bettina E., Zeuzem, Stefan, Vanwolleghem, Thomas, Janssen, Harry L.A., de Man, Robert A., Feld, Jordan J., van der Meer, Adriaan J., Krassenburg, Lisette A.P., Maan, Raoel, Puenpatom, Amy, Erler, Nicole S., Welsch, Christoph, van Hees, Stijn, Cerrhoci, Orlando, Vermehren, Johannes, de Knegt, Robert J., Hansen, Bettina E., Zeuzem, Stefan, Vanwolleghem, Thomas, Janssen, Harry L.A., de Man, Robert A., Feld, Jordan J., and van der Meer, Adriaan J.

Abstract

Background and aims:Historical paired liver biopsy studies are likely to underestimate current progression of disease in patients with chronic hepatitis C virus (HCV) infection. We aimed to assess liver disease progression according to the non-invasive Fibrosis-4 (FIB-4) index in patients with chronic HCV and early disease. Methods and results:Patients diagnosed with chronic HCV and FIB-4 <3.25 from four international liver clinics were included in a retrospective cohort study. Follow-up ended at start of antiviral therapy resulting in sustained virological response, at time of liver transplantation or death. Primary outcome of advanced liver disease was defined as FIB-4 >3.25 during follow-up. Survival analyses were used to assess time to FIB-4 >3.25. In total, 4286 patients were followed for a median of 5.0 (IQR 1.7-9.4) years, during which 41 071 FIB-4 measurements were collected. At baseline, median age was 47 (IQR 39-55) years, 2529 (59.0%) were male, and 2787 (65.0%) patients had a FIB-4 <1.45. Advanced liver disease developed in 821 patients. Overall, 10-year cumulative incidence of advanced disease was 32.1% (95% CI 29.9% to 34.3%). Patients who developed advanced disease showed an exponential FIB-4 increase. Among patients with a presumed date of HCV infection, cumulative incidence of advanced disease increased 7.7-fold from 20 to 40 years as opposed to the first 20 years after HCV infection. Conclusions:The rate of advanced liver disease is high among chronic HCV-infected patients with early disease at time of diagnosis, among whom liver disease progression accelerated over time. These results emphasise the need to overcome any limitations with respect to diagnosing and treating all patients with chronic HCV across the globe.

Published
2023

16. Impact of Molnupiravir Treatment on Patient-Reported COVID-19 Symptoms in the Phase 3 MOVe-OUT Trial: A Randomized, Placebo-Controlled Trial.

Author

Guan, Yanfen, Puenpatom, Amy, Johnson, Matthew G, Zhang, Ying, Zhao, Yujie, Surber, Joseph, Weinberg, Aaron, Brotons, Carlos, Kozlov, Roman, Lopez, Rudy, Coetzee, Kathleen, Santiaguel, Joel, Du, Jiejun, Williams-Diaz, Angela, Brown, Michelle, Paschke, Amanda, Anda, Carisa De, and Norquist, Josephine M

Subjects
*STATISTICS, *DISEASE progression, *COVID-19, *ANTIVIRAL agents, *HEALTH outcome assessment, *PUBLIC health, *TREATMENT effectiveness, *COMPARATIVE studies, *PLACEBOS, *KAPLAN-Meier estimator, *DESCRIPTIVE statistics, *RESEARCH funding, *DATA analysis, *SECONDARY analysis, *PROPORTIONAL hazards models, *PATIENT safety
Abstract

Background Molnupiravir is an orally administered antiviral authorized for COVID-19 treatment in adults at high risk of progression to severe disease. Here, we report secondary and post hoc analyses of participants' self-reported symptoms in the MOVe-OUT trial, which evaluated molnupiravir initiated within 5 days of symptom onset in nonhospitalized, unvaccinated adults with mild-to-moderate, laboratory-confirmed COVID-19. Methods Eligible participants completed a 15-item symptom diary daily from day 1 (randomization) through day 29, rating symptom severity as "none," "mild," "moderate," or "severe"; loss of smell and loss of taste were rated as "yes" or "no." Time to sustained symptom resolution/improvement was defined as the number of days from randomization to the first of 3 consecutive days of reduced severity, without subsequent relapse. Time to symptom progression was defined as the number of days from randomization to the first of 2 consecutive days of worsening severity. The Kaplan-Meier method was used to estimate event rates at various time points. The Cox proportional hazards model was used to estimate the hazard ratio between molnupiravir and placebo. Results For most targeted COVID-19 symptoms, sustained resolution/improvement was more likely, and progression was less likely, in the molnupiravir versus placebo group through day 29. When evaluating 5 distinctive symptoms of COVID-19, molnupiravir participants had a shorter median time to first resolution (18 vs 20 d) and first alleviation (13 vs 15 d) of symptoms compared with placebo. Conclusions Molnupiravir treatment in at-risk, unvaccinated patients resulted in improved clinical outcomes for most participant-reported COVID-19 symptoms compared with placebo. Clinical Trials Registration.  ClinicalTrials.gov: NCT04575597. [ABSTRACT FROM AUTHOR]

Published
2023
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20. Health-related quality of life in people receiving opioid agonist treatment and treatment for hepatitis C virus infection

Author

Dalgard, Olav, primary, Litwin, Alain H., additional, Shibolet, Oren, additional, Grebely, Jason, additional, Nahass, Ronald, additional, Altice, Frederick L., additional, Conway, Brian, additional, Gane, Edward J., additional, Luetkemeyer, Anne F., additional, Peng, Cheng-Yuan, additional, Iser, David, additional, Gendrano, Isaias Noel, additional, Kelly, Michelle M., additional, Haber, Barbara A., additional, Platt, Heather, additional, and Puenpatom, Amy, additional

Published
2022
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21. Effect of Molnupiravir on Biomarkers, Respiratory Interventions, and Medical Services in COVID-19

Author

Johnson, Matthew G., primary, Puenpatom, Amy, additional, Moncada, Pablo Andrés, additional, Burgess, Lesley, additional, Duke, Elizabeth R., additional, Ohmagari, Norio, additional, Wolf, Timo, additional, Bassetti, Matteo, additional, Bhagani, Sanjay, additional, Ghosn, Jade, additional, Zhang, Ying, additional, Wan, Hong, additional, Williams-Diaz, Angela, additional, Brown, Michelle L., additional, Paschke, Amanda, additional, and De Anda, Carisa, additional

Published
2022
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22. Health-related quality of life in people receiving opioid agonist treatment and treatment for hepatitis C virus infection.

Author

Dalgard, Olav, Litwin, Alain H., Shibolet, Oren, Grebely, Jason, Nahass, Ronald, Altice, Frederick L., Conway, Brian, Gane, Edward J., Luetkemeyer, Anne F., Peng, Cheng-Yuan, Iser, David, Gendrano, Isaias Noel, Kelly, Michelle M., Haber, Barbara A., Platt, Heather, and Puenpatom, Amy

Subjects
NARCOTICS, DRUG addiction, NARCOTIC antagonists, CONFIDENCE intervals, HEPATITIS C, ANTIVIRAL agents, RANDOMIZED controlled trials, QUALITY of life, DESCRIPTIVE statistics, QUESTIONNAIRES, RESEARCH funding, STATISTICAL sampling
Abstract

In people with chronic hepatitis C virus (HCV) infection, viral eradication is associated with improved health-related quality of life (HRQOL). To assess changes in HRQOL among participants receiving opioid agonist therapy undergoing treatment for HCV infection COSTAR (NCT02251990) was a randomized, double-blind, placebo-controlled study. Adults with HCV infection on opioid agonist therapy received elbasvir (50 mg)/grazoprevir (100 mg) or placebo for 12 weeks. HRQOL was evaluated using the Medical Outcomes Study 36-Item Short Form Health Survey version 2 (SF-36v2) Acute Form. Participants remained blinded until 4 weeks after end of treatment. Overall, 201 participants received elbasvir/grazoprevir and 100 participants received placebo. Treatment difference mean change from baseline scores (elbasvir/grazoprevir minus placebo) indicated an improvement in HRQOL at 4 weeks after end of treatment in participants receiving elbasvir/grazoprevir versus those receiving placebo, driven by declining HRQOL in those receiving placebo and improved HRQOL in certain domains among participants receiving elbasvir/grazoprevir. Notable differences in SF-36v2 scores were evident in the general health (mean treatment difference [MTD], 6.00; 95% CI, 1.37–10.63), vitality (MTD, 6.81; 95% CI, 1.88–11.75), and mental health (MTD, 5.17; 95% CI, 0.52–9.82) domains and in the mental component summary score (mean, 2.83; 95% CI, 0.29–5.37). No notable between-treatment differences were evident at treatment weeks 4 or 12. HRQOL in patients receiving medication for opioid dependence was improved following treatment for HCV infection with elbasvir/grazoprevir, suggesting that eradication of HCV infection with direct-acting antivirals is associated with improved HRQOL. ClinicalTrials.gov, NCT02251990 [ABSTRACT FROM AUTHOR]

Published
2023
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23. Effectiveness of Golimumab as Second Anti-TNFα Drug in Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis in Italy: GO-BEYOND, a Prospective Real-World Observational Study

Author

D’Angelo, Salvatore, primary, Tirri, Enrico, additional, Giardino, Angela Maria, additional, Mattucci-Cerinic, Marco, additional, Dagna, Lorenzo, additional, Santo, Leonardo, additional, Ciccia, Francesco, additional, Frediani, Bruno, additional, Govoni, Marcello, additional, Bobbio Pallavicini, Francesca, additional, Grembiale, Rosa Daniela, additional, Delle Sedie, Andrea, additional, Mulè, Rita, additional, Cantatore, Francesco Paolo, additional, Foti, Rosario, additional, Gremese, Elisa, additional, Conigliaro, Paola, additional, Salaffi, Fausto, additional, Viapiana, Ombretta, additional, Cauli, Alberto, additional, Giacomelli, Roberto, additional, Arcarese, Luisa, additional, Guggino, Giuliana, additional, Russo, Romualdo, additional, Puenpatom, Amy, additional, Capocotta, Domenico, additional, Nacci, Francesca, additional, Anelli, Maria Grazia, additional, Picerno, Valentina, additional, Binetti, Corrado, additional, and Iannone, Florenzo, additional

Published
2022
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28. Real-World Patient Experience of Switching Biologic Treatment in Inflammatory Arthritis and Ulcerative Colitis – A Systematic Literature Review

Author

Luttropp,Karin, Dalén,Johan, Svedbom,Axel, Dozier,Mary, Black,Christopher M, and Puenpatom,Amy

Subjects
Patient Preference and Adherence
Abstract

Karin Luttropp, 1 Johan Dalén, 1 Axel Svedbom, 1 Mary Dozier, 2 Christopher M Black, 3 Amy Puenpatom 3 1ICON Clinical Research, Plc., Stockholm, Sweden; 2ICON Clinical Research, Plc., Boston, MA, USA; 3Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ, USACorrespondence: Amy PuenpatomCenter of Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, NJ Tel +1 267 305 0620Fax +1 215 850 4549Email puenpatom.amy@merck.comPurpose: To obtain an up-to-date overview of the measurement of patient experience of switching biologic treatment in patients with inflammatory arthritis (IA) or ulcerative colitis (UC). Secondary objectives included summarizing the types of patient-reported outcomes (PROs) used (if any), and related findings; and summarizing medical and non-medical reasons for treatment switch and/or discontinuation.Methods: A systematic literature review (SLR) was performed, searching Medline and Embase for relevant publications.Results: In total, 70 relevant publications were identified. While the majority of these reported reasons for switching and/or discontinuing treatment, only four provided information explicitly regarding patient-reported experience of switching biologic treatment. All four utilized ranking tools to assess patient experience of switching biologic treatment. The most common reason for switching and/or discontinuing treatment was loss of efficacy, while the least common reason was patient preference.Conclusion: Although the number of available treatments in IA and UC have increased, there is a sparsity of information regarding patient-reported experience of switching biologic treatment. Further research regarding patient preference and/or experience would benefit this therapeutic area and help guide treatment choices.Keywords: arthritis, colitis, ulcerative, biological products, patient reported outcome measures, treatment switch

Published
2020

37. Patient-reported outcomes among people receiving opioid agonist therapy and treatment for hepatitis C virus infection: results from CO-STAR

Author

Dalgard, Olav, primary, Litwin, Alain, additional, Dore, Gregory, additional, Shibolet, Oren, additional, Grebely, Jason, additional, Nahass, Ronald, additional, Altice, Frederick, additional, Conway, Brian, additional, Gane, Edward, additional, Luetkemeyer, Anne, additional, Peng, Cheng-Yuan, additional, Iser, David, additional, Gendrano, Isaias Noel, additional, Kelly, Michelle M., additional, Haber, Barbara, additional, Platt, Heather Loryn, additional, and Puenpatom, Amy, additional

Published
2020
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38. Efficacy and safety of elbasvir/grazoprevir in treatment‐naive Chinese adults with hepatitis C virus infection: A randomized trial

Author

Wei, Lai, primary, Jia, Ji Dong, additional, Duan, Zhong Ping, additional, Wang, Fu Sheng, additional, Niu, Jun Qi, additional, Xie, Wen, additional, Huang, Wen Xiang, additional, Zhang, Ming Xiang, additional, Huang, Yan, additional, Wang, Mao Rong, additional, Wu, Shan Ming, additional, Zhao, Ying Ren, additional, Jia, Zhan Sheng, additional, Zhao, Xu Min, additional, Mu, Sheng Mei, additional, Liang, Li Wen, additional, Wang, Zaiqi, additional, Puenpatom, Amy, additional, Hwang, Peggy, additional, Robertson, Michael N., additional, Ingravallo, Paul, additional, Asante‐Appiah, Ernest, additional, Wei, Bo, additional, Evans, Barbara, additional, Hanna, George J., additional, and Talwani, Rohit, additional

Published
2020
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