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P.253 Rapid virological response in genotype 1b patients treated with peginterferon plus ribavirin: evidence for a significant sustained virological response (SVR) after 24 weeks of therapy in peg-interferon-alpha-2a treated patients
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Journal of Clinical Virology 2006, Vol 36 (suppl 2)
HCV RNA after 4 weeks of treatment with peginterferon alpha-2a and ribavirin achieve high response rates with 12 weeks of therapy. Methods: This study was conducted at Shifa International hospital after approval of institutional review board. Study recruitment period was between January 2005 and March 2005. One hundred consecutive patients with HCV genotype 2 and 3 between 18 and 50 years were enrolled in the study. All of these patients were administered Pegylated Interferon alpha-2a 180 pg weekly and 400 mg of Ribavirin twice daily. Repeat HCV PCR was done at 4 weeks. If the HCV PCR was negative, they were given further 12 weeks of therapy. This was designated as the fixed regimen group. If the HCVPCR checked at 4 weeks was positive, these patients were rechecked at 12 weeks and if negative, they were given a total of 24 weeks of therapy. This group was designated as the variable treatment group. Results: Of the 100 consecutive patients, 70 (70%) were male, 30 (30%) were female. Median age was 40 years. There were 25 (25%) patients with genotype 2 and 75 (75%) patients with genotype 3. A total of 79 out of 85 patients in the fixed treatment group achieved SVR. There was no difference between the two groups with respect to SVR (92.94% vs. 87.5%; p-value 0.5770). There was no difference in sustained viral response rate with respect to the genotype (86.95% vs. 94.28%; p-value 0.23). Conclusion: 16-weeks treatment regimen comprising of PEGinterferon and ribavirin might be a viable option for patients with HCV genotypes 2 or 3 who obtain a virological response after 4 weeks of therapy. This report might particularly be interesting for countries where HCV genotypes 2 and 3 are more prevalent. Further studies are needed to endorse or reject this idea as well as determine the cost effectiveness of this regimen.
I ~
Rapid virological response in genotype l b patients treated with peginterferon plus ribavirin: evidence for a significant sustained virological response (SVR) after 24 weeks of therapy in peg-interferon-alpha-2a treated patients
M. Persico*, M. Svelto, V. La Mura, M. Masarone, F. Moschella, R. Torella. Internal Medicine and Hepatology, Second University of
Naples, Napoli, Italy Background and Objectives: The combination of peginterferon plus ribavirin is considered therapy of choice for patients with HCVrelated chronic hepatitis. Rapid Virological Response (RVR) is defined as a >2 log decrease in serum HCV RNA level from baseline or no detectable serum HCV RNA at the end of 4 weeks of therapy. Aim of the study was to show, in genotype l b patients with RVR, if a reduced 24 weeks exposure to the antiviral therapy might have the same efficacy as 48 weeks treatment. Methods: This is a retrospective study where we evaluated RVR, and in patients HCVRNA negative at the end of 4 weeks of therapy we evaluated the Sustained Virological Response (SVR) after 24 and 48 weeks of therapy, in a cohort of 180 genotype 1 b patients treated with peginterferon alpha-2a or peginterferon alpha-2b plus ribavirin. Results: Of the 180 patients, 53% were treated with peginterferon alpha-2a (180pg/wk) and 47% with peginterferon alpha-2b (1.5 pg/kg/wk). 119 (66%) exhibited an Early Virological Response (EVR) and all achieved an end-of-treatment response (ETR) at 48 weeks. Among EVR patients, 55 (46%) were treated with peginterferon alpha-2a and 64 (54%) were treated with peginterferon alpha-2b. 78 of the 180 patients (43%) had an SVR, 39 (50%) were treated with peginterferon alpha-2a and 39 (50%) were treated with peginterferon alpha-2b. Among the EVR patients, 22 (18%) exhibited a RVR and 17 of these 22 patients (77%) achieved an SVR. Of the 22 patients who exhibited an RVR, 20 (91%) were treated with peginterferon alpha-2a and 2 (9%) with peginterferon alpha-2b. Of the 22 patients who exhibited RVR, 9 discontinued treatment after 24 weeks and 13 followed 48 weeks of treatment. No difference of SVR was documented in the two groups. Conclusion: In conclusion, the first "stopping rule" to optimize the treatment might be defined after 4 weeks of therapy. No difference of SVR was found between the two different treatments, however the prevalence of patients treated with peginterferon alpha-2a who achieved a RVR was significantly higher compared to those treated with peginterferon alpha-2b. In patients who achieve RVR, 24 weeks
Abstracts, 12th ISHVLD instead of 48 weeks of therapy may be possible. A randomized controlled trial to confirm these observations in our cohort is warranted.
[-P-~
Australian trial in acute hepatitis C: baseline behavioural data
M. Hellard 1 *, Iq Haber 2, C. Day 2, Iq Marks 2, G. Matthews 2, B. Yeung 2, O. Nguyen 2, K. Dolan 2, I. Van Beek 2, J. Kaldor 2, G. Dore 2 . 1Centre for Epidemiolgy and Population Health Research,
Burnet Institute, Melbourne; 2ATAHC Protocol Steering Committee, National Centre for HIV Epidemiology and Clinical Research, Sydney, Australia Background and Objectives: Research into the treatment of acute hepatitis C (AHC) has included few individuals with injecting drug use (IDU)-acquired infection. Potential barriers to HCV treatment in the IDU population are discrimination by health care professionals, lack of adequate primary health care services, frequency of drug use and degree of drug dependency, treatment-related toxicity, and a perception of poor treatment adherence. Methods: The Australian Trial in Acute Hepatitis C (ATAHC) study is examining natural history and treatment efficacy among predominantly IDU-acquired AHC. Subjects are eligible if they have anti-HCV seroconversion within 24 months, or acute clinical hepatitis C and are enrolled within 6 months of anti-HCV antibody positive result. All eligible subjects are offered treatment with pegylated interferon ,Y,-2a (PEG-IFN) for 24 weeks. Demographics, drug and alcohol, drug treatment history and injecting behaviour are collected at regular intervals. Results: Ninety subjects have been screened and 70 have been enrolled in the ATAHC study. Baseline data is available on 50 participants; 39 of these reported ever injecting drugs and 32 are current injecting drug users (injected within the last six months). Heroin was the most common drug injected. Forty-five participants were HCV PCR at baseline and therefore potentially eligible for treatment of whom 32 had ever injected drugs and 28 were current IDUs. Thirty-five of the 43 commenced on treatment. Nine (90%) of ten participants without a history of injecting drugs were on treatment compared with 26 (79%) of 33 participants who reported ever injecting drugs. Nine (64%) of 14 participants who reported injecting drugs in the past month were on treatment compared with 26 (90%) of 29 participants who reported injecting drugs more than one month previously (p=0.06). Rates of drug dependency treatment were similar between treated and untreated groups. Conclusion: Although not statistically significant, this preliminary data suggests that AHC treatment uptake may be influenced by patterns of injecting drug use. Behavioural follow-up data is currently being collected to examine the impact of injecting behaviour on treatment adherence and response rates.
Journal of Clinical Virology 2006, Vol 36 (suppl 2)
HCV RNA after 4 weeks of treatment with peginterferon alpha-2a and ribavirin achieve high response rates with 12 weeks of therapy. Methods: This study was conducted at Shifa International hospital after approval of institutional review board. Study recruitment period was between January 2005 and March 2005. One hundred consecutive patients with HCV genotype 2 and 3 between 18 and 50 years were enrolled in the study. All of these patients were administered Pegylated Interferon alpha-2a 180 pg weekly and 400 mg of Ribavirin twice daily. Repeat HCV PCR was done at 4 weeks. If the HCV PCR was negative, they were given further 12 weeks of therapy. This was designated as the fixed regimen group. If the HCVPCR checked at 4 weeks was positive, these patients were rechecked at 12 weeks and if negative, they were given a total of 24 weeks of therapy. This group was designated as the variable treatment group. Results: Of the 100 consecutive patients, 70 (70%) were male, 30 (30%) were female. Median age was 40 years. There were 25 (25%) patients with genotype 2 and 75 (75%) patients with genotype 3. A total of 79 out of 85 patients in the fixed treatment group achieved SVR. There was no difference between the two groups with respect to SVR (92.94% vs. 87.5%; p-value 0.5770). There was no difference in sustained viral response rate with respect to the genotype (86.95% vs. 94.28%; p-value 0.23). Conclusion: 16-weeks treatment regimen comprising of PEGinterferon and ribavirin might be a viable option for patients with HCV genotypes 2 or 3 who obtain a virological response after 4 weeks of therapy. This report might particularly be interesting for countries where HCV genotypes 2 and 3 are more prevalent. Further studies are needed to endorse or reject this idea as well as determine the cost effectiveness of this regimen.
I ~
Rapid virological response in genotype l b patients treated with peginterferon plus ribavirin: evidence for a significant sustained virological response (SVR) after 24 weeks of therapy in peg-interferon-alpha-2a treated patients
M. Persico*, M. Svelto, V. La Mura, M. Masarone, F. Moschella, R. Torella. Internal Medicine and Hepatology, Second University of
Naples, Napoli, Italy Background and Objectives: The combination of peginterferon plus ribavirin is considered therapy of choice for patients with HCVrelated chronic hepatitis. Rapid Virological Response (RVR) is defined as a >2 log decrease in serum HCV RNA level from baseline or no detectable serum HCV RNA at the end of 4 weeks of therapy. Aim of the study was to show, in genotype l b patients with RVR, if a reduced 24 weeks exposure to the antiviral therapy might have the same efficacy as 48 weeks treatment. Methods: This is a retrospective study where we evaluated RVR, and in patients HCVRNA negative at the end of 4 weeks of therapy we evaluated the Sustained Virological Response (SVR) after 24 and 48 weeks of therapy, in a cohort of 180 genotype 1 b patients treated with peginterferon alpha-2a or peginterferon alpha-2b plus ribavirin. Results: Of the 180 patients, 53% were treated with peginterferon alpha-2a (180pg/wk) and 47% with peginterferon alpha-2b (1.5 pg/kg/wk). 119 (66%) exhibited an Early Virological Response (EVR) and all achieved an end-of-treatment response (ETR) at 48 weeks. Among EVR patients, 55 (46%) were treated with peginterferon alpha-2a and 64 (54%) were treated with peginterferon alpha-2b. 78 of the 180 patients (43%) had an SVR, 39 (50%) were treated with peginterferon alpha-2a and 39 (50%) were treated with peginterferon alpha-2b. Among the EVR patients, 22 (18%) exhibited a RVR and 17 of these 22 patients (77%) achieved an SVR. Of the 22 patients who exhibited an RVR, 20 (91%) were treated with peginterferon alpha-2a and 2 (9%) with peginterferon alpha-2b. Of the 22 patients who exhibited RVR, 9 discontinued treatment after 24 weeks and 13 followed 48 weeks of treatment. No difference of SVR was documented in the two groups. Conclusion: In conclusion, the first "stopping rule" to optimize the treatment might be defined after 4 weeks of therapy. No difference of SVR was found between the two different treatments, however the prevalence of patients treated with peginterferon alpha-2a who achieved a RVR was significantly higher compared to those treated with peginterferon alpha-2b. In patients who achieve RVR, 24 weeks
Abstracts, 12th ISHVLD instead of 48 weeks of therapy may be possible. A randomized controlled trial to confirm these observations in our cohort is warranted.
[-P-~
Australian trial in acute hepatitis C: baseline behavioural data
M. Hellard 1 *, Iq Haber 2, C. Day 2, Iq Marks 2, G. Matthews 2, B. Yeung 2, O. Nguyen 2, K. Dolan 2, I. Van Beek 2, J. Kaldor 2, G. Dore 2 . 1Centre for Epidemiolgy and Population Health Research,
Burnet Institute, Melbourne; 2ATAHC Protocol Steering Committee, National Centre for HIV Epidemiology and Clinical Research, Sydney, Australia Background and Objectives: Research into the treatment of acute hepatitis C (AHC) has included few individuals with injecting drug use (IDU)-acquired infection. Potential barriers to HCV treatment in the IDU population are discrimination by health care professionals, lack of adequate primary health care services, frequency of drug use and degree of drug dependency, treatment-related toxicity, and a perception of poor treatment adherence. Methods: The Australian Trial in Acute Hepatitis C (ATAHC) study is examining natural history and treatment efficacy among predominantly IDU-acquired AHC. Subjects are eligible if they have anti-HCV seroconversion within 24 months, or acute clinical hepatitis C and are enrolled within 6 months of anti-HCV antibody positive result. All eligible subjects are offered treatment with pegylated interferon ,Y,-2a (PEG-IFN) for 24 weeks. Demographics, drug and alcohol, drug treatment history and injecting behaviour are collected at regular intervals. Results: Ninety subjects have been screened and 70 have been enrolled in the ATAHC study. Baseline data is available on 50 participants; 39 of these reported ever injecting drugs and 32 are current injecting drug users (injected within the last six months). Heroin was the most common drug injected. Forty-five participants were HCV PCR at baseline and therefore potentially eligible for treatment of whom 32 had ever injected drugs and 28 were current IDUs. Thirty-five of the 43 commenced on treatment. Nine (90%) of ten participants without a history of injecting drugs were on treatment compared with 26 (79%) of 33 participants who reported ever injecting drugs. Nine (64%) of 14 participants who reported injecting drugs in the past month were on treatment compared with 26 (90%) of 29 participants who reported injecting drugs more than one month previously (p=0.06). Rates of drug dependency treatment were similar between treated and untreated groups. Conclusion: Although not statistically significant, this preliminary data suggests that AHC treatment uptake may be influenced by patterns of injecting drug use. Behavioural follow-up data is currently being collected to examine the impact of injecting behaviour on treatment adherence and response rates.