Limits...
Pretreatment prediction of the outcome of response-guided peginterferon-α and ribavirin therapy for chronic hepatitis C.

Masaki N, Sugiyama M, Shimada N, Tanaka Y, Nakamuta M, Izumi N, Watanabe S, Tsubota A, Komatsu M, Masaki T, Enomoto N, Yoneda M, Murata K, Ito K, Koike K, Mizokami M - J. Gastroenterol. Hepatol. (2014)

Bottom Line: The accuracy for predicting virological outcomes of peginterferon-α and ribavirin therapy in patients with chronic hepatitis C is limited to approximately 80%, even with IL28B genotyping.Our in vitro study revealed that the numbers of (TA) dinucleotide repeats [(TA)n] of rs72258881, which is located in the promoter region of IL28B gene, might regulate IL28B transcription.We aimed to evaluate the usefulness of these host factors for predicting virological outcomes of this therapy in response-guided clinical settings.

View Article: PubMed Central - PubMed

Affiliation: The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Chiba, Japan.

Show MeSH

Related in: MedlinePlus

Enrollment and outcomes. Among 233 patients enrolled in this study, 18 patients were ineligible for the following reasons: genotype non-1 (2b) (n = 1); low viral load (n = 15); and unknown viral load (n = 2). Consequently, 215 patients met the entry criteria, and were treated with peginterferon and ribavirin. Among them, 160 patients completed standard of care (SOC). The remaining 55 patients were withdrawn from SOC, as detailed earlier. The virological outcomes with intent-to-treat analysis, as detailed in the Methods section, were shown as a pie chart for each group. *Serious adverse events were duplicated in some patients. RGT, response-guided therapy; SAE, serious adverse events; SVR, sustained virological response; TVR, transient virological response; NVR, non-virological response; R, responder; f/u, follow-up. , SVR; , TVR; , Partial R (NVR); , Null R (NVR); , undetemined (NVR); , Lost-to-f/u.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4263356&req=5

fig02: Enrollment and outcomes. Among 233 patients enrolled in this study, 18 patients were ineligible for the following reasons: genotype non-1 (2b) (n = 1); low viral load (n = 15); and unknown viral load (n = 2). Consequently, 215 patients met the entry criteria, and were treated with peginterferon and ribavirin. Among them, 160 patients completed standard of care (SOC). The remaining 55 patients were withdrawn from SOC, as detailed earlier. The virological outcomes with intent-to-treat analysis, as detailed in the Methods section, were shown as a pie chart for each group. *Serious adverse events were duplicated in some patients. RGT, response-guided therapy; SAE, serious adverse events; SVR, sustained virological response; TVR, transient virological response; NVR, non-virological response; R, responder; f/u, follow-up. , SVR; , TVR; , Partial R (NVR); , Null R (NVR); , undetemined (NVR); , Lost-to-f/u.

Mentions: In this prospective study, 215 patients infected by HCV of serotype 1 or genotype 1 were eligible. The sub-genotypes of HCV were as follows: 1a (n = 2), 1b (n = 208), 1b + 2b (n = 1), and indeterminate (n = 4). By the end of November 2012, virological outcomes had been determined in 202 patients, except for 13 patients (6%) who were lost to follow-up. Whereas all of these patients were treated with P/R, 160 patients (74%) completed standard of care (SOC) treatment for at least 48 weeks, the remaining 55 patients had to withdraw from treatment owing to either serious adverse events (SAE) in 25 patients (12%), poor response in 24 patients (11%), or other unrelated causes in 6 patients (3%). The SAE or unrelated causes responsible for the termination of the treatment were described in the small inset of Figure 2.


Pretreatment prediction of the outcome of response-guided peginterferon-α and ribavirin therapy for chronic hepatitis C.

Masaki N, Sugiyama M, Shimada N, Tanaka Y, Nakamuta M, Izumi N, Watanabe S, Tsubota A, Komatsu M, Masaki T, Enomoto N, Yoneda M, Murata K, Ito K, Koike K, Mizokami M - J. Gastroenterol. Hepatol. (2014)

Enrollment and outcomes. Among 233 patients enrolled in this study, 18 patients were ineligible for the following reasons: genotype non-1 (2b) (n = 1); low viral load (n = 15); and unknown viral load (n = 2). Consequently, 215 patients met the entry criteria, and were treated with peginterferon and ribavirin. Among them, 160 patients completed standard of care (SOC). The remaining 55 patients were withdrawn from SOC, as detailed earlier. The virological outcomes with intent-to-treat analysis, as detailed in the Methods section, were shown as a pie chart for each group. *Serious adverse events were duplicated in some patients. RGT, response-guided therapy; SAE, serious adverse events; SVR, sustained virological response; TVR, transient virological response; NVR, non-virological response; R, responder; f/u, follow-up. , SVR; , TVR; , Partial R (NVR); , Null R (NVR); , undetemined (NVR); , Lost-to-f/u.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4263356&req=5

fig02: Enrollment and outcomes. Among 233 patients enrolled in this study, 18 patients were ineligible for the following reasons: genotype non-1 (2b) (n = 1); low viral load (n = 15); and unknown viral load (n = 2). Consequently, 215 patients met the entry criteria, and were treated with peginterferon and ribavirin. Among them, 160 patients completed standard of care (SOC). The remaining 55 patients were withdrawn from SOC, as detailed earlier. The virological outcomes with intent-to-treat analysis, as detailed in the Methods section, were shown as a pie chart for each group. *Serious adverse events were duplicated in some patients. RGT, response-guided therapy; SAE, serious adverse events; SVR, sustained virological response; TVR, transient virological response; NVR, non-virological response; R, responder; f/u, follow-up. , SVR; , TVR; , Partial R (NVR); , Null R (NVR); , undetemined (NVR); , Lost-to-f/u.
Mentions: In this prospective study, 215 patients infected by HCV of serotype 1 or genotype 1 were eligible. The sub-genotypes of HCV were as follows: 1a (n = 2), 1b (n = 208), 1b + 2b (n = 1), and indeterminate (n = 4). By the end of November 2012, virological outcomes had been determined in 202 patients, except for 13 patients (6%) who were lost to follow-up. Whereas all of these patients were treated with P/R, 160 patients (74%) completed standard of care (SOC) treatment for at least 48 weeks, the remaining 55 patients had to withdraw from treatment owing to either serious adverse events (SAE) in 25 patients (12%), poor response in 24 patients (11%), or other unrelated causes in 6 patients (3%). The SAE or unrelated causes responsible for the termination of the treatment were described in the small inset of Figure 2.

Bottom Line: The accuracy for predicting virological outcomes of peginterferon-α and ribavirin therapy in patients with chronic hepatitis C is limited to approximately 80%, even with IL28B genotyping.Our in vitro study revealed that the numbers of (TA) dinucleotide repeats [(TA)n] of rs72258881, which is located in the promoter region of IL28B gene, might regulate IL28B transcription.We aimed to evaluate the usefulness of these host factors for predicting virological outcomes of this therapy in response-guided clinical settings.

View Article: PubMed Central - PubMed

Affiliation: The Research Center for Hepatitis and Immunology, National Center for Global Health and Medicine, Chiba, Japan.

Show MeSH
Related in: MedlinePlus