PittsburghV1, Main, Exploration, bibRecord, 000864

Virologic response and haematologic toxicity of boceprevir- and telaprevir-containing regimens in actual clinical settings

Identifieur interne : 000864 ( Main/Exploration ); précédent : 000863; suivant : 000865

Virologic response and haematologic toxicity of boceprevir- and telaprevir-containing regimens in actual clinical settings

Auteurs : A. A. Butt [États-Unis, Qatar] ; P. Yan [États-Unis] ; O. S. Shaikh [États-Unis] ; M. S. Freiberg [États-Unis] ; V. Lo Re [États-Unis] ; A. C. Justice [États-Unis] ; K. E. Sherman [États-Unis]

Source :

Journal of viral hepatitis [ 1352-0504 ] ; 2014.

RBID : PMC:5020421

Descripteurs français

KwdFr :
- ARN viral (sang), Adulte d'âge moyen, Antiviraux (effets indésirables), Antiviraux (usage thérapeutique), Anémie (), Anémie (épidémiologie), Charge virale, Effets secondaires indésirables des médicaments (épidémiologie), Femelle, Hepacivirus (isolement et purification), Humains, Hépatite C chronique (traitement médicamenteux), Hépatite C chronique (virologie), Mâle, Neutropénie (), Neutropénie (épidémiologie), Oligopeptides (effets indésirables), Oligopeptides (usage thérapeutique), Proline (analogues et dérivés), Proline (effets indésirables), Proline (usage thérapeutique), Résultat thérapeutique, Sujet âgé, Thrombopénie (), Thrombopénie (épidémiologie), Études de cohortes.
MESH :
- analogues et dérivés : Proline.
- effets indésirables : Antiviraux, Oligopeptides, Proline.
- isolement et purification : Hepacivirus.
- sang : ARN viral.
- traitement médicamenteux : Hépatite C chronique.
- usage thérapeutique : Antiviraux, Oligopeptides, Proline.
- virologie : Hépatite C chronique.
- épidémiologie : Anémie, Effets secondaires indésirables des médicaments, Neutropénie, Thrombopénie.
- Adulte d'âge moyen, Anémie, Charge virale, Femelle, Humains, Mâle, Neutropénie, Résultat thérapeutique, Sujet âgé, Thrombopénie, Études de cohortes.

English descriptors

KwdEn :
- Aged, Anemia (chemically induced), Anemia (epidemiology), Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Cohort Studies, Drug-Related Side Effects and Adverse Reactions (epidemiology), Female, Hepacivirus (isolation & purification), Hepatitis C, Chronic (drug therapy), Hepatitis C, Chronic (virology), Humans, Male, Middle Aged, Neutropenia (chemically induced), Neutropenia (epidemiology), Oligopeptides (adverse effects), Oligopeptides (therapeutic use), Proline (adverse effects), Proline (analogs & derivatives), Proline (therapeutic use), RNA, Viral (blood), Thrombocytopenia (chemically induced), Thrombocytopenia (epidemiology), Treatment Outcome, Viral Load.
MESH :
- chemical , adverse effects : Antiviral Agents, Oligopeptides, Proline.
- chemical , analogs & derivatives : Proline.
- chemical , blood : RNA, Viral.
- chemically induced : Anemia, Neutropenia, Thrombocytopenia.
- drug therapy : Hepatitis C, Chronic.
- epidemiology : Anemia, Drug-Related Side Effects and Adverse Reactions, Neutropenia, Thrombocytopenia.
- isolation & purification : Hepacivirus.
- chemical , therapeutic use : Antiviral Agents, Oligopeptides, Proline.
- virology : Hepatitis C, Chronic.
- Aged, Cohort Studies, Female, Humans, Male, Middle Aged, Treatment Outcome, Viral Load.

Abstract

SUMMARY

Effectiveness, safety and tolerability of boceprevir (BOC) and telaprevir (TPV) in actual clinical settings remain unknown. We determined rates of sustained virologic response (SVR) and haematologic adverse effects among persons treated with BOC- or TPV-containing regimens, compared with pegylated interferon/ribavirin (PEG/RBV). Using an established cohort of hepatitis C virus (HCV)-infected persons, Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES), we identified those treated with a BOC- or TPV-containing regimen and HCV genotype 1-infected controls treated with PEG/RBV. We excluded those with HIV co-infection and missing HCV RNA values to determine SVR. Primary endpoints were SVR (undetectable HCV RNA ≥12 weeks after treatment completion) and haematologic toxicity (grade 3/4 anaemia, neutropenia and thrombocytopenia). We evaluated 2288 persons on BOC-, 409 on TPV-containing regimen and 6308 on PEG/RBV. Among these groups, respectively, 31%, 43% and 9% were treatment-experienced; 17%, 37% and 14% had baseline cirrhosis; 63%, 54% and 48% were genotype 1a. SVR rates among noncirrhotics were as follows: treatment naïve: 65% (BOC), 67% (TPV) and 31% (PEG/RBV); treatment experienced: 57% (BOC), 54% (TPV) and 13% (PEG/RBV); (P-value not significant for BOC vs TPV; P < 0.0001 for BOC or TPV vs PEG/RBV). Haematologic toxicities among BOC-, TPV- and PEG/RBV-treated groups were as follows: grade 3/4 anaemia 7%, 11% and 3%; grade 4 thrombocytopenia 2.2%, 5.4% and 1.7%; grade 4 neutropenia 8.2%, 5.6% and 3.4%. SVR rates are higher and closer to those reported in pivotal clinical trials among BOC- and TPV-treated persons compared with PEG/RBV-treated persons. Haematologic adverse events are frequent, but severe toxicity is uncommon.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5020421

DOI: 10.1111/jvh.12375
PubMed: 25524834
PubMed Central: 5020421

Affiliations:

Qatar, États-Unis
Connecticut, Ohio, Pennsylvanie, Tennessee

Le document en format XML

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<term>Antiviral Agents (therapeutic use)</term>
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<term>Oligopeptides</term>
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<term>Effets secondaires indésirables des médicaments</term>
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<front><div type="abstract" xml:lang="en"><title>SUMMARY</title>
<p id="P1">Effectiveness, safety and tolerability of boceprevir (BOC) and telaprevir (TPV) in actual clinical settings remain unknown. We determined rates of sustained virologic response (SVR) and haematologic adverse effects among persons treated with BOC- or TPV-containing regimens, compared with pegylated interferon/ribavirin (PEG/RBV). Using an established cohort of hepatitis C virus (HCV)-infected persons, Electronically Retrieved Cohort of HCV Infected Veterans (ERCHIVES), we identified those treated with a BOC- or TPV-containing regimen and HCV genotype 1-infected controls treated with PEG/RBV. We excluded those with HIV co-infection and missing HCV RNA values to determine SVR. Primary endpoints were SVR (undetectable HCV RNA ≥12 weeks after treatment completion) and haematologic toxicity (grade 3/4 anaemia, neutropenia and thrombocytopenia). We evaluated 2288 persons on BOC-, 409 on TPV-containing regimen and 6308 on PEG/RBV. Among these groups, respectively, 31%, 43% and 9% were treatment-experienced; 17%, 37% and 14% had baseline cirrhosis; 63%, 54% and 48% were genotype 1a. SVR rates among noncirrhotics were as follows: treatment naïve: 65% (BOC), 67% (TPV) and 31% (PEG/RBV); treatment experienced: 57% (BOC), 54% (TPV) and 13% (PEG/RBV); (<italic>P</italic>
-value not significant for BOC <italic>vs</italic>
 TPV; <italic>P</italic>
 < 0.0001 for BOC or TPV <italic>vs</italic>
 PEG/RBV). Haematologic toxicities among BOC-, TPV- and PEG/RBV-treated groups were as follows: grade 3/4 anaemia 7%, 11% and 3%; grade 4 thrombocytopenia 2.2%, 5.4% and 1.7%; grade 4 neutropenia 8.2%, 5.6% and 3.4%. SVR rates are higher and closer to those reported in pivotal clinical trials among BOC- and TPV-treated persons compared with PEG/RBV-treated persons. Haematologic adverse events are frequent, but severe toxicity is uncommon.</p>
</div>
</front>
</TEI>
<affiliations><list><country><li>Qatar</li>
<li>États-Unis</li>
</country>
<region><li>Connecticut</li>
<li>Ohio</li>
<li>Pennsylvanie</li>
<li>Tennessee</li>
</region>
</list>
<tree><country name="États-Unis"><region name="Pennsylvanie"><name sortKey="Butt, A A" sort="Butt, A A" uniqKey="Butt A" first="A. A." last="Butt">A. A. Butt</name>
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<name sortKey="Justice, A C" sort="Justice, A C" uniqKey="Justice A" first="A. C." last="Justice">A. C. Justice</name>
<name sortKey="Justice, A C" sort="Justice, A C" uniqKey="Justice A" first="A. C." last="Justice">A. C. Justice</name>
<name sortKey="Re, V Lo" sort="Re, V Lo" uniqKey="Re V" first="V. Lo" last="Re">V. Lo Re</name>
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<name sortKey="Shaikh, O S" sort="Shaikh, O S" uniqKey="Shaikh O" first="O. S." last="Shaikh">O. S. Shaikh</name>
<name sortKey="Sherman, K E" sort="Sherman, K E" uniqKey="Sherman K" first="K. E." last="Sherman">K. E. Sherman</name>
<name sortKey="Yan, P" sort="Yan, P" uniqKey="Yan P" first="P." last="Yan">P. Yan</name>
</country>
<country name="Qatar"><noRegion><name sortKey="Butt, A A" sort="Butt, A A" uniqKey="Butt A" first="A. A." last="Butt">A. A. Butt</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Virologic response and haematologic toxicity of boceprevir- and telaprevir-containing regimens in actual clinical settings

Virologic response and haematologic toxicity of boceprevir- and telaprevir-containing regimens in actual clinical settings

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