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Article ; Online: Hepatitis C therapy with grazoprevir/elbasvir and glecaprevir/pibrentasvir in patients with advanced chronic kidney disease: data from the German Hepatitis C-Registry (DHC-R).

Stein, Kerstin / Stoehr, Albrecht / Klinker, Hartwig / Teuber, Gerlinde / Naumann, Uwe / John, Christine / Heyne, Renate / Serfert, Yvonne / Niederau, Claus / Zeuzem, Stefan / Berg, Thomas / Wiegand, Johannes

European journal of gastroenterology & hepatology

2020 Volume 34, Issue 1, Page(s) 76–83

Abstract: ... treatment options for patients with chronic hepatitis C virus (HCV) infection and ... of both regimens in a concerted real-life population.: Methods: The Germany Hepatitis C-Registry is ... with chronic hepatitis C and a baseline GFR ≤30 mL/min grazoprevir/elbasvir and glecaprevir/pibrentasvir show ...

Abstract	Objectives: Grazoprevir/elbasvir and glecaprevir/pibrentasvir (G/P) are the two preferred treatment options for patients with chronic hepatitis C virus (HCV) infection and a glomerular filtration rate (GFR) <30 mL/min. Both therapies have been separately analyzed in different real-life cohorts; however, a direct comparison has not been performed so far. We, therefore, analyzed safety and effectiveness of both regimens in a concerted real-life population. Methods: The Germany Hepatitis C-Registry is a prospective national real-world registry. The analysis is based on 2773 patients with documented GFR at baseline treated with grazoprevir/elbasvir (N = 1041), grazoprevir/elbasvir + ribavirin (N = 53) and glecaprevir/pibrentasvir (N = 1679). Results: A total of 93 patients with GFR <30 mL/min were treated with grazoprevir/elbasvir (N = 56), grazoprevir/elbasvir + ribavirin (N = 4), and glecaprevir/pibrentasvir (N = 33). They suffered significantly more frequent from diabetes mellitus, hypertension, and coronary heart disease than individuals with GFR >30 mL/min and showed the following baseline characteristics: 20.4, 55.9, 3.2, 12.9, and 5.3% were infected with HCV-genotypes 1a, 1b, 2, 3, and 4; 12.9% suffered from liver cirrhosis; 80.1% were treatment-naïve. Baseline characteristics except distribution of HCV-genotype 1b (n = 43/52 treated with grazoprevir/elbasvir) and sustained virologic response rates (SVR12) did not differ significantly between glecaprevir/pibrentasvir (SVR12: 100%) and grazoprevir/elbasvir (SVR12: 97.9%).Fatigue, headache, abdominal discomfort, and arthralgia were the most frequently reported adverse events without a statistical difference between grazoprevir/elbasvir and glecaprevir/pibrentasvir. Conclusion: In patients with chronic hepatitis C and a baseline GFR ≤30 mL/min grazoprevir/elbasvir and glecaprevir/pibrentasvir show an equally favorable safety profile and antiviral efficacy and can both be recommended for real-life use.
MeSH term(s)	Amides ; Aminoisobutyric Acids ; Antiviral Agents/adverse effects ; Benzimidazoles ; Benzofurans ; Carbamates ; Cyclopropanes ; Drug Therapy, Combination ; Genotype ; Hepacivirus/genetics ; Hepatitis C/drug therapy ; Hepatitis C, Chronic/diagnosis ; Hepatitis C, Chronic/drug therapy ; Humans ; Imidazoles ; Lactams, Macrocyclic ; Leucine/analogs & derivatives ; Proline/analogs & derivatives ; Prospective Studies ; Pyrrolidines ; Quinoxalines/adverse effects ; Registries ; Renal Insufficiency, Chronic/diagnosis ; Ribavirin/therapeutic use ; Sulfonamides ; Sustained Virologic Response
Chemical Substances	Amides ; Aminoisobutyric Acids ; Antiviral Agents ; Benzimidazoles ; Benzofurans ; Carbamates ; Cyclopropanes ; Imidazoles ; Lactams, Macrocyclic ; Pyrrolidines ; Quinoxalines ; Sulfonamides ; pibrentasvir (2WU922TK3L) ; Ribavirin (49717AWG6K) ; grazoprevir (4O2AB118LA) ; elbasvir (632L571YDK) ; Proline (9DLQ4CIU6V) ; Leucine (GMW67QNF9C) ; glecaprevir (K6BUU8J72P)
Language	English
Publishing date	2020-09-11
Publishing country	England
Document type	Journal Article
ZDB-ID	1034239-4
ISSN	1473-5687 ; 0954-691X
ISSN (online)	1473-5687
ISSN	0954-691X
DOI	10.1097/MEG.0000000000001923
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Article ; Online: Increased use of cross-sectional imaging for follow-up does not improve post-recurrence survival of surgically treated initially localized R.C.C.: results from a European multicenter database (R.E.C.U.R.).

Dabestani, Saeed / Beisland, Christian / Stewart, Grant D / Bensalah, Karim / Gudmundsson, Eirikur / Lam, Thomas B / Gietzmann, William / Zakikhani, Paimaun / Marconi, Lorenzo / Fernandéz-Pello, Sergio / Monagas, Serenella / Williams, Samuel P / Powles, Thomas / Van Werkhoven, Erik / Meijer, Richard / Volpe, Alessandro / Staehler, Michael / Ljungberg, Börje / Bex, Axel

Scandinavian journal of urology

2019 Volume 53, Issue 1, Page(s) 14–20

Abstract: Objective: ...

Abstract	Objective:
MeSH term(s)	Aged ; Carcinoma, Renal Cell/diagnostic imaging ; Carcinoma, Renal Cell/mortality ; Carcinoma, Renal Cell/surgery ; Databases, Factual ; Diagnostic Imaging/methods ; Europe ; Female ; Follow-Up Studies ; Humans ; Kidney Neoplasms/diagnostic imaging ; Kidney Neoplasms/mortality ; Kidney Neoplasms/surgery ; Male ; Middle Aged ; Neoplasm Recurrence, Local/diagnostic imaging ; Neoplasm Recurrence, Local/mortality ; Prognosis ; Retrospective Studies ; Risk Factors ; Survival Rate
Language	English
Publishing date	2019-03-25
Publishing country	England
Document type	Journal Article ; Multicenter Study
ZDB-ID	2701936-6
ISSN	2168-1813 ; 2168-1805
ISSN (online)	2168-1813
ISSN	2168-1805
DOI	10.1080/21681805.2019.1588919
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Article ; Online: Deutsches Hepatitis C-Register (DHC-R) – eine Zwischenbilanz 4 Jahre nach Zulassung direkt antiviraler Substanzen (DAAs).

Hüppe, Dietrich / Serfert, Yvonne / Buggisch, Peter / Mauss, Stefan / Böker, Klaus H W / Müller, Tobias / Klinker, Hartwig / Günther, Rainer / Berg, Thomas / Cornberg, Markus / Niederau, Claus / Sarrazin, Christoph / Simon, Karl-Georg / Zeuzem, Stefan / Manns, Michael P / Wedemeyer, Heiner

Zeitschrift fur Gastroenterologie

2019 Volume 57, Issue 1, Page(s) 27–36

Abstract: ... DHC-R) is to describe the epidemiology and patient care of hepatitis C and to investigate the efficacy ... Background: More than 250 000 patients suffer from chronic hepatitis C in Germany. Several potent ... direct-acting antiviral drugs have been approved since 2014. The aim of the German Hepatitis C-Registry ...

Title translation	4 years of direct-acting antivirals (DAAs) in the German Hepatitis C-Registry (DHC-R).
Abstract	Background: More than 250 000 patients suffer from chronic hepatitis C in Germany. Several potent, direct-acting antiviral drugs have been approved since 2014. The aim of the German Hepatitis C-Registry (DHC-R) is to describe the epidemiology and patient care of hepatitis C and to investigate the efficacy and safety of new treatment options in real-world settings. Methods: The DHC-R is a prospective multicenter non-interventional registry study that includes 327 centers throughout Germany. All approved treatment options have been documented. The current analysis differentiated 4 phases: 2/2014 - 12/2014, 1/2015 - 12/2015, 1/2016 - 7/2017 and 8/2017 - 7/2018. Findings: Between February 2014 and July 2018, 12 170 patients were included in the registry (61.3 % male), and antiviral treatment was initiated in 11 268. The mean age declined from 52.3 years (phase 1) to 49.3 years (phase 4), while the proportion of patients with previous or ongoing drug abuse increased (26.3 % to 43.1 %). In 2014, 35.1 % of treated patients had liver cirrhosis, which declined to 16.5 % in phase 4. The HCV genotype distribution showed marked fluctuations, with most recent increases in HCV genotype 3 (30 % in phase 4). Per-protocol sustained virological response rates increased from 92.8 % in 2014 to 94.4 % in 2017/18 with excellent tolerability. Summary: The DHC-R mirrors patient care of chronic hepatitis in the real-world setting in Germany and provides insights into epidemiology developments. It also confirms the high efficacy and safety of novel treatment options.
MeSH term(s)	Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Drug-Related Side Effects and Adverse Reactions/epidemiology ; Female ; Germany/epidemiology ; Hepacivirus ; Hepatitis C, Chronic/drug therapy ; Hepatitis C, Chronic/epidemiology ; Hepatitis C, Chronic/virology ; Humans ; Male ; Middle Aged ; Prospective Studies ; Registries ; Sustained Virologic Response ; Treatment Outcome
Chemical Substances	Antiviral Agents
Language	German
Publishing date	2019-01-14
Publishing country	Germany
Document type	Journal Article
ZDB-ID	201387-3
ISSN	1439-7803 ; 0172-8504 ; 0044-2771
ISSN (online)	1439-7803
ISSN	0172-8504 ; 0044-2771
DOI	10.1055/a-0821-7188
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Zs.A 111: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
Zs.A 111/X: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)

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Article ; Online: ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis.

Poordad, Fred / Hezode, Christophe / Trinh, Roger / Kowdley, Kris V / Zeuzem, Stefan / Agarwal, Kosh / Shiffman, Mitchell L / Wedemeyer, Heiner / Berg, Thomas / Yoshida, Eric M / Forns, Xavier / Lovell, Sandra S / Da Silva-Tillmann, Barbara / Collins, Christine A / Campbell, Andrew L / Podsadecki, Thomas / Bernstein, Barry

The New England journal of medicine

2014 Volume 370, Issue 21, Page(s) 1973–1982

Abstract: Background: Interferon-containing regimens for the treatment of hepatitis C virus (HCV) infection ... the interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r), the NS5A inhibitor ... A cirrhosis to receive either 12 or 24 weeks of treatment with ABT-450/r-ombitasvir (at a once-daily dose ...

Abstract	Background: Interferon-containing regimens for the treatment of hepatitis C virus (HCV) infection are associated with increased toxic effects in patients who also have cirrhosis. We evaluated the interferon-free combination of the protease inhibitor ABT-450 with ritonavir (ABT-450/r), the NS5A inhibitor ombitasvir (ABT-267), the nonnucleoside polymerase inhibitor dasabuvir (ABT-333), and ribavirin in an open-label phase 3 trial involving previously untreated and previously treated adults with HCV genotype 1 infection and compensated cirrhosis. Methods: We randomly assigned 380 patients with Child-Pugh class A cirrhosis to receive either 12 or 24 weeks of treatment with ABT-450/r-ombitasvir (at a once-daily dose of 150 mg of ABT-450, 100 mg of ritonavir, and 25 mg of ombitasvir), dasabuvir (250 mg twice daily), and ribavirin administered according to body weight. The primary efficacy end point was a sustained virologic response 12 weeks after the end of treatment. The rate of sustained virologic response in each group was compared with the estimated rate with a telaprevir-based regimen (47%; 95% confidence interval [CI], 41 to 54). A noninferiority margin of 10.5 percentage points established 43% as the noninferiority threshold; the superiority threshold was 54%. Results: A total of 191 of 208 patients who received 12 weeks of treatment had a sustained virologic response at post-treatment week 12, for a rate of 91.8% (97.5% CI, 87.6 to 96.1). A total of 165 of 172 patients who received 24 weeks of treatment had a sustained virologic response at post-treatment week 12, for a rate of 95.9% (97.5% CI, 92.6 to 99.3). These rates were superior to the historical control rate. The three most common adverse events were fatigue (in 32.7% of patients in the 12-week group and 46.5% of patients in the 24-week group), headache (in 27.9% and 30.8%, respectively), and nausea (in 17.8% and 20.3%, respectively). The hemoglobin level was less than 10 g per deciliter in 7.2% and 11.0% of patients in the respective groups. Overall, 2.1% of patients discontinued treatment owing to adverse events. Conclusions: In this phase 3 trial of an oral, interferon-free regimen evaluated exclusively in patients with HCV genotype 1 infection and cirrhosis, multitargeted therapy with the use of three new antiviral agents and ribavirin resulted in high rates of sustained virologic response. Drug discontinuations due to adverse events were infrequent. (Funded by AbbVie; TURQUOISE-II ClinicalTrials.gov number, NCT01704755.).
MeSH term(s)	Adult ; Aged ; Anilides/adverse effects ; Anilides/therapeutic use ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Carbamates/adverse effects ; Carbamates/therapeutic use ; Drug Resistance, Viral ; Drug Therapy, Combination ; Female ; Genotype ; Hepacivirus/genetics ; Hepacivirus/isolation & purification ; Hepatitis C, Chronic/complications ; Hepatitis C, Chronic/drug therapy ; Humans ; Liver Cirrhosis/drug therapy ; Liver Cirrhosis/etiology ; Logistic Models ; Macrocyclic Compounds/adverse effects ; Macrocyclic Compounds/therapeutic use ; Male ; Middle Aged ; Recurrence ; Ribavirin/adverse effects ; Ribavirin/therapeutic use
Chemical Substances	Anilides ; Antiviral Agents ; Carbamates ; Macrocyclic Compounds ; ombitasvir (2302768XJ8) ; Ribavirin (49717AWG6K) ; paritaprevir (OU2YM37K86)
Language	English
Publishing date	2014-04-11
Publishing country	United States
Document type	Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa1402869
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Article ; Online: Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R).

Cornberg, Markus / Stoehr, Albrecht / Naumann, Uwe / Teuber, Gerlinde / Klinker, Hartwig / Lutz, Thomas / Möller, Hjördis / Hidde, Dennis / Lohmann, Kristina / Simon, Karl-Georg

Viruses

2022 Volume 14, Issue 7

Abstract: Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report ... in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is ...

Abstract	Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational cohort study on patients treated for chronic HCV infection in Germany. The data cutoff was 17 January 2021. The primary effectiveness endpoint was sustained virologic response at post-treatment Week 12 (SVR12). Safety outcomes were assessed in all patients receiving GLE/PIB. PROs were assessed using the SF-36 survey. Of 2354 patients, 1964 had valid SVR12 data (intention-to-treat analysis). Of these, 1905 (97.0%) achieved SVR12 with rates similar across the comorbidities analyzed, except for people who actively use drugs (PWUD (active)) (86.4%). Excluding those who discontinued treatment and did not achieve SVR12, or were reinfected with HCV, the rate was 99.3%, with similar results regardless of comorbidity. PWUD (active) and those with psychiatric disorders had the most meaningful improvements in PROs. Adverse events (AEs) occurred in 631/2354 patients (26.8%), and serious AEs in 44 patients (1.9%). GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination.
MeSH term(s)	Aminoisobutyric Acids ; Antiviral Agents/adverse effects ; Benzimidazoles ; Cyclopropanes ; Genotype ; Hepacivirus/genetics ; Hepatitis C, Chronic/drug therapy ; Humans ; Lactams, Macrocyclic ; Leucine/analogs & derivatives ; Patient Reported Outcome Measures ; Proline/analogs & derivatives ; Prospective Studies ; Pyrrolidines ; Quinoxalines ; Registries ; Sulfonamides
Chemical Substances	Aminoisobutyric Acids ; Antiviral Agents ; Benzimidazoles ; Cyclopropanes ; Lactams, Macrocyclic ; Pyrrolidines ; Quinoxalines ; Sulfonamides ; pibrentasvir (2WU922TK3L) ; Proline (9DLQ4CIU6V) ; Leucine (GMW67QNF9C) ; glecaprevir (K6BUU8J72P)
Language	English
Publishing date	2022-07-14
Publishing country	Switzerland
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	2516098-9
ISSN	1999-4915 ; 1999-4915
ISSN (online)	1999-4915
ISSN	1999-4915
DOI	10.3390/v14071541
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Article ; Online: A randomized controlled trial of H uman P apilloma v irus (HPV) testing fo r c ervic al cancer screening

Smith Laurie W / Peacock Stuart J / Ceballos Kathy / Ehlen Thomas G / Martin Ruth E / Krajden Mel / van Niekerk Dirk J / Ogilvie Gina S / Kan Lisa / Cook Darrel A / Mei Wendy / Stuart Gavin CE / Franco Eduardo L / Coldman Andrew J

BMC Cancer, Vol 10, Iss 1, p

trial design and preliminary results (HPV FOCAL Trial)

2010 Volume 111

Abstract: Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 ...

Abstract	Abstract Background In the HPV FOCAL trial, we will establish the efficacy of hr-HPV DNA testing as a stand-alone screening test followed by liquid based cytology (LBC) triage of hr-HPV-positive women compared to LBC followed by hr-HPV triage with ≥ CIN3 as the outcome. Methods/Design HPV-FOCAL is a randomized, controlled, three-armed study over a four year period conducted in British Columbia. It will recruit 33,000 women aged 25-65 through the province's population based cervical cancer screening program. Control arm: LBC at entry and two years, and combined LBC and hr-HPV at four years among those with initial negative results and hr-HPV triage of ASCUS cases; Two Year Safety Check arm : hr-HPV at entry and LBC at two years in those with initial negative results with LBC triage of hr-HPV positives; Four Year Intervention Arm : hr-HPV at entry and combined hr-HPV and LBC at four years among those with initial negative results with LBC triage of hr-HPV positive cases Discussion To date, 6150 participants have a completed sample and epidemiologic questionnaire. Of the 2019 women enrolled in the control arm, 1908 (94.5%) were cytology negative. Women aged 25-29 had the highest rates of HSIL (1.4%). In the safety arm 92.2% of women were hr-HPV negative, with the highest rate of hr-HPV positivity found in 25-29 year old women (23.5%). Similar results were obtained in the intervention arm HPV FOCAL is the first randomized trial in North America to examine hr-HPV testing as the primary screen for cervical cancer within a population-based cervical cancer screening program. Trial Registration International Standard Randomised Controlled Trial Number Register, ISRCTN79347302
Keywords	Neoplasms. Tumors. Oncology. Including cancer and carcinogens ; RC254-282 ; Internal medicine ; RC31-1245 ; Medicine ; R ; DOAJ:Oncology ; DOAJ:Medicine (General) ; DOAJ:Health Sciences
Language	English
Publishing date	2010-03-01T00:00:00Z
Publisher	BioMed Central
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Deutsches Hepatitis C-Register (DHC-R) – eine Zwischenbilanz 4 Jahre nach Zulassung direkt antiviraler Substanzen (DAAs)

Hüppe, Dietrich / Serfert, Yvonne / Buggisch, Peter / Mauss, Stefan / Böker, Klaus H.W. / Müller, Tobias / Klinker, Hartwig / Günther, Rainer / Berg, Thomas / Cornberg, Markus / Niederau, Claus / Sarrazin, Christoph / Simon, Karl-Georg / Zeuzem, Stefan / Manns, Michael P. / Wedemeyer, Heiner

Zeitschrift für Gastroenterologie

2019 Volume 57, Issue 01, Page(s) 27–36

Abstract: ... des Deutschen Hepatitis-C-Registers (DHC-R) ist es, die Epidemiologie und Versorgung von Patienten mit CHC ... Einleitung: In Deutschland sind mehr als 250 000 Patienten an einer chronischen Hepatitis C (CHC ... zu untersuchen.: Methoden: Das DHC-R ist eine prospektive, multizentrische, nicht interventionelle ...

Abstract	Einleitung: In Deutschland sind mehr als 250 000 Patienten an einer chronischen Hepatitis C (CHC) erkrankt. Seit 2014 sind zahlreiche potente direkt antivirale Substanzen gegen HCV zugelassen worden. Ziel des Deutschen Hepatitis-C-Registers (DHC-R) ist es, die Epidemiologie und Versorgung von Patienten mit CHC abzubilden und die Effektivität und Sicherheit der neuen Behandlungsmöglichkeiten im Praxisalltag zu untersuchen. Methoden: Das DHC-R ist eine prospektive, multizentrische, nicht interventionelle Registerstudie. Bundesweit sind 327 Zentren für die Dokumentation freigeschaltet. Alle in Deutschland zugelassenen Medikamente wurden im DHC-R dokumentiert. Für die aktuelle Auswertung wurden 4 Phasen unterschieden: 2/2014 bis 12/2014, 1/2015 bis 12/2015, 1/2016 bis 7/2017 und 8/2017 bis 7/2018. Ergebnisse: Zwischen Februar 2014 und Juli 2018 wurden 12 170 Patienten in das Register eingeschlossen (61,3 % Männer), eine antivirale Therapie erhielten 11 268. Das Behandlungsalter sank von 52,3 (Phase 1) auf 49,3 Jahre (Phase 4), der Anteil der Behandelten mit einer Drogenanamnese nahm zu (von 26,9 auf 43,1 %). 2014 wurden viele Patienten mit Leberzirrhose (35,1 %) behandelt, deren Anteil im Verlauf deutlich abnahm (Phase 4: 16,5 %). Die HCV-Genotypenverteilung änderte sich im Zeitverlauf deutlich, zuletzt stieg der Anteil des HCV-Genotyps 3 (30 % in Phase 4). Die Ausheilungsrate (PP-Analyse) steigerte sich von 92,8 % im Jahre 2014 auf zuletzt 97,4 % bei sehr guter Verträglichkeit. Zusammenfassung: Das DHC-R beschreibt die Versorgungssituation der Patienten mit CHC in Deutschland, zeigt epidemiologische Tendenzen auf und belegt die ausgezeichneten Behandlungsmöglichkeiten.
Keywords	chronische Hepatitis C ; Leberzirrhose ; anhaltendes virologisches Ansprechen ; direkt antivirale Substanzen ; chronic hepatitis C ; liver cirrhosis ; sustained virological response ; direct acting antivirals
Language	German
Publishing date	2019-01-01
Publisher	© Georg Thieme Verlag KG
Publishing place	Stuttgart ; New York
Document type	Article
ZDB-ID	201387-3
ISSN	1439-7803 ; 0044-2771 ; 0172-8504
ISSN (online)	1439-7803
ISSN	0044-2771 ; 0172-8504
DOI	10.1055/a-0821-7188
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Zs.A 111: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Isolation of sutherlandins A, B, C and D from Sutherlandia frutescens (L.) R. Br. by counter-current chromatography using spiral tubing support rotors.

Chen, Cuiping / Folk, William R / Lazo-Portugal, Rodrigo / Finn, Thomas M / Knight, Martha

Journal of chromatography. A

2017 Volume 1508, Page(s) 7–15

Abstract: ... from the widely used South African medicinal plant, Sutherlandia frutescens (L.) R. Br. In the spiral tubing ...

Abstract	Spiral countercurrent-chromatography has great potential for improving the capacity and efficiency of purification of secondary metabolites, and here we describe applications useful for the isolation of flavonoids from the widely used South African medicinal plant, Sutherlandia frutescens (L.) R. Br. In the spiral tubing support rotor, STS-4 for high-speed counter-current chromatography, several polar butanol aqueous solvent systems were selected using a logK plot, and the novel flavonol glycosides (sutherlandins A-D) were well separated by the optimized solvent system (ethyl acetate:n-butanol:acetic acid:water; 5:1:0.3:6 by vol.). The yield of purified flavonoids from 0.9g extract varied from 8.6mg to 54mg of the sutherlandins for a total of 85.3mg. The same extract was fractionated in the new STS-12 rotor of the same outside dimensions but with more radial channels forming 12 loops of the tubing instead of 4. The rotor holds more layers and increased length of tubing. From 0.9g extract the STS-12 rotor yielded more recovery of 110.4mg total with amounts varying from 11.2mg to 64mg of the sutherlandins and apparent increased separation efficiency as noted by less volume of each fraction peak. Thus from 1-g amounts of extract, good recovery of the flavonoids was achieved in the butanol aqueous solvent system.
MeSH term(s)	Countercurrent Distribution/instrumentation ; Countercurrent Distribution/methods ; Fabaceae/chemistry ; Flavonoids/analysis ; Flavonoids/isolation & purification ; Plant Extracts/analysis ; Plant Extracts/isolation & purification ; Plants, Medicinal/chemistry
Chemical Substances	Flavonoids ; Plant Extracts
Language	English
Publishing date	2017-07-28
Publishing country	Netherlands
Document type	Evaluation Studies ; Journal Article
ZDB-ID	1171488-8
ISSN	1873-3778 ; 0021-9673
ISSN (online)	1873-3778
ISSN	0021-9673
DOI	10.1016/j.chroma.2017.05.027
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Article: Real-World Safety, Effectiveness, and Patient-Reported Outcomes in Patients with Chronic Hepatitis C Virus Infection Treated with Glecaprevir/Pibrentasvir: Updated Data from the German Hepatitis C-Registry (DHC-R)

Cornberg, Markus / Stoehr, Albrecht / Naumann, Uwe / Teuber, Gerlinde / Klinker, Hartwig / Lutz, Thomas / Möller, Hjördis / Hidde, Dennis / Lohmann, Kristina / Simon, Karl-Georg

Viruses. 2022 July 14, v. 14, no. 7

2022

Abstract	Using data from the German Hepatitis C-Registry (Deutsche Hepatitis C-Register, DHC-R), we report the real-world safety and effectiveness of glecaprevir/pibrentasvir (GLE/PIB) treatment and its impact on patient-reported outcomes (PROs) in underserved populations who are not typically included in clinical trials, yet who will be crucial for achieving hepatitis C virus (HCV) elimination. The DHC-R is an ongoing, non-interventional, multicenter, prospective, observational cohort study on patients treated for chronic HCV infection in Germany. The data cutoff was 17 January 2021. The primary effectiveness endpoint was sustained virologic response at post-treatment Week 12 (SVR12). Safety outcomes were assessed in all patients receiving GLE/PIB. PROs were assessed using the SF-36 survey. Of 2354 patients, 1964 had valid SVR12 data (intention-to-treat analysis). Of these, 1905 (97.0%) achieved SVR12 with rates similar across the comorbidities analyzed, except for people who actively use drugs (PWUD (active)) (86.4%). Excluding those who discontinued treatment and did not achieve SVR12, or were reinfected with HCV, the rate was 99.3%, with similar results regardless of comorbidity. PWUD (active) and those with psychiatric disorders had the most meaningful improvements in PROs. Adverse events (AEs) occurred in 631/2354 patients (26.8%), and serious AEs in 44 patients (1.9%). GLE/PIB was highly effective and well tolerated in this real-world study of patient groups key to HCV elimination.
Keywords	Hepatitis C virus ; chronic hepatitis C ; cohort studies ; comorbidity ; patients ; people ; Germany
Language	English
Dates of publication	2022-0714
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2516098-9
ISSN	1999-4915
ISSN	1999-4915
DOI	10.3390/v14071541
Database	NAL-Catalogue (AGRICOLA)

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Article: Isolation of sutherlandins A, B, C and D from Sutherlandia frutescens (L.) R. Br. by counter-current chromatography using spiral tubing support rotors

Chen, Cuiping / William R. Folk / Rodrigo Lazo-Portugal / Thomas M. Finn / Martha Knight

Journal of chromatography. 2017 July 28, v. 1508

2017

Abstract: ... from the widely used South African medicinal plant, Sutherlandia frutescens (L.) R. Br. In the spiral tubing ...

Abstract	Spiral countercurrent-chromatography has great potential for improving the capacity and efficiency of purification of secondary metabolites, and here we describe applications useful for the isolation of flavonoids from the widely used South African medicinal plant, Sutherlandia frutescens (L.) R. Br. In the spiral tubing support rotor, STS-4 for high-speed counter-current chromatography, several polar butanol aqueous solvent systems were selected using a logK plot, and the novel flavonol glycosides (sutherlandins AâD) were well separated by the optimized solvent system (ethyl acetate:n-butanol:acetic acid:water; 5:1:0.3:6 by vol.). The yield of purified flavonoids from 0.9g extract varied from 8.6mg to 54mg of the sutherlandins for a total of 85.3mg. The same extract was fractionated in the new STS-12 rotor of the same outside dimensions but with more radial channels forming 12 loops of the tubing instead of 4. The rotor holds more layers and increased length of tubing. From 0.9g extract the STS-12 rotor yielded more recovery of 110.4mg total with amounts varying from 11.2mg to 64mg of the sutherlandins and apparent increased separation efficiency as noted by less volume of each fraction peak. Thus from 1-g amounts of extract, good recovery of the flavonoids was achieved in the butanol aqueous solvent system.
Keywords	Lessertia frutescens ; bromine ; butanol ; countercurrent chromatography ; flavonols ; glycosides ; medicinal plants ; rotors ; secondary metabolites ; solvents
Language	English
Dates of publication	2017-0728
Size	p. 7-15.
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	218139-3
ISSN	0021-9673 ; 0378-4355 ; 0376-737X
ISSN	0021-9673 ; 0378-4355 ; 0376-737X
DOI	10.1016/j.chroma.2017.05.027
Database	NAL-Catalogue (AGRICOLA)

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