OUTCOMES OF CONSESUS INTERFERON AND RIBAVIRIN THERAPY FOR CHRONIC HEPATITIS C GENOTYPE 3 PATIENTS WHO RELAPSED WITH PREVIOUS PEGYLATED INTERFERON AND RIBAVIRIN THERAPY.

Authors: Uzma Adeeb ,Fatima Khattak , Muzzaffar Gill, .

Maroof International Hospital Islamabad.

Aims and objectives: There are no published studies about the efficacy of Consensus Interferon and Ribavirin combination in chronic hepatitis C(Genotype 3) relapsers wiith Peginterferon Ribavirin combination therapy. To evaluate the efficacy of consensus interferon and Ribavirin in patients previously treated with Pegylated interferon and Ribavirin combination therapy. We consecutively enrolled 70 patients with chronic hepatitis C Genotype 3 who relapsed with previous treatment with Pegylated interferon for atleast 6 months.

Methods: The study was conducted between Feb 2009 to March 2010.

Inclusion criteria: Chronic hepatitis C Genotype 3 relapsers patients with documented history of Pegylated interferon and Ribavirin therapy for 6 months.

Exclusion criteria: Active psychiatric history, platelet count < 75000, INR > 1.5, S. Albumin < 2.5, portal vein diameter > 13mm on ultrasound and active ischemic heart disease.

All enrolled patients have CBC, ALT, HCV PCR quantitative, HCV genotype, thyroid function tests .and blood sugar. .Patients were given 15ug thrice weekly consensus interferon and Ribavirin 400mg bid.The treatment duration was for 9 months. Patients were reviewed 4 weekly basis for clinical examination and CBC. We did check HCV PCR quantitative @week 12.. The patients who had HCV PCR negative or 50% reduction in HCV PCR at week 12 were given further 3 months of therapy.

Results: Among 70 patients 45 were male and 25 were female. Median age was 45.60 out of 70t(85%) patients were HCVPCR negative @ week 12 of therapy. These 60 patients completed further 24 weeks of therapy and remained HCVPCR negative @ end of total 24 weeks of therapy .Five patients stopped treatment because of side effects and financial constrains.

Conclusion: Consensus interferon (infergen) Ribavirin combination is very optimistic option for HEP C Genotype 3 relapsers with Peg Interferon Ribavirin combination. We are interested in SVR (sustained virological response) in this group and this cohort is part of our continuous study to determine SVR Further studies are needed to confirm/refute this observation. We did give 9 months of therapy because of financial consideration.

Efficacy of Peg-Interferon Alfa 2a/Ribavirin for HEPC Genotype 3 Relapsers with standard interferon/Ribavirin.

Saima Firdoos, Syma Sattar, Shaheen Mufti, Nasir Khokhar Muzzaffar Gill. Shifa International Hospital, Islamabad, Pakistan.

Background: It is fairly common to treat Hep C genotype 3 patients with standard interferon / Ribavirin. There is 15-20 percent relapse rate. There are no published studies in Pakistan to evaluate the Peg-interferon/Riba combination in this population. We carried out a Prospective study in our institution.

Methods: We enrolled 90 patients from our outpatient clinic who had 6 months treatment with standard Interferon and Ribavirin and were HCVPCR negative after 6 months of therapy. The patients who were HCVPCR positive after 12-18 months of stopping treatment were considered eligible for this therapy. The study period was between Jan 2005 to Jan 2006. Patients with established cirrhosis were excluded from this study. Eligible patients were given Pegasys 180 ucg weekly and Ribavirin 10 mg/kg body weight daily. These patients were seen every four weeks with CBC and ALT results. HCVPCR qualitative was checked after 12 weeks, patients who were HCVPCR negative were given this therapy for next six months.

Results: 60-patients were male and 30 were female, mean age was 45. 8 patients out of 90 were lost to follow up. 50 out of 90 (55percent) patients who were HCVPCR negative continued treatment for another six months. At the end of 9 months therapy, 45 out of 90 (50 percent) remained HCVPCR negative.

Conclusion: Peg-interferon alfa 2a (pegasys) with Ribavirin has reasonable efficacy for Hep C genotype 3 relapsers with standard interferon/Ribavirin combination.

Address for Correspondence:

Prof. Muzzaffar Lateef Gill

Division of Gastroenterology

Shifa International Hospital Islamabad-Pakistan.

<3>Outcomes of PEG-interferon alfa2b/Ribavirin Treatment in HEPC G3 Younger VS Older Patients.Saima Firdoos, Saima Sattar, Tauqir A. Shah, Muzzaffar Gill. Shifa International Hospital, Islamabad, Pakistan.

There is a strong bias against treating older patients with Hepatitis C. There is a widely held notion about the decreased efficacy of PEG-Interferon and high incidence of side effects. We wanted to determine age as an independent predictor of sustained virological response (SVR), and study the side effects profile.

Methods: we did retrospective analysis of cohort of 150 chronic hepatitis C genotype 3 patients who were treated with Peginterferon alfa2a 1.5ucg/kg per week and 800 mg of Ribavirin daily for 6 months. The study period was between January 2005 to July 2006. We divided the patients into three age groups 25-40, 41-55 and 56-70. We did logistic regression analysis of sustained virological response (SVR) comparing three age groups.

Results: There were 50 patients in each age group. The overall SVR was 80 percent. SVR rates for age groups: 25-40 years were 82 percent, 41-55 years were 80 percent (p=0.84VS 25-40) and 56-70 years was 75 percent (p=0.60 VS 25-40). There was no difference in SVR in any age group. There was no difference in serious side effects between all age groups.

Conclusion: Peg-Interferon alfa 2b and Ribavirin is effective therapy across all age groups. Chronic HEPC patients should not be denied treatment because of their age.

Address for Correspondence:

Prof. Muzzaffar Lateef Gill

Division of Gastroenterology,

Shifa International Hospital Islamabad-Pakistan.

Long term outcomes of treatment of Hepatitis C Genotype 3 patients with thrice weekly standard Interferon and Ribavirin.

Aqifa Amin, Saima Firdoos, Nasir Khokhar, Muzzaffar Gill

Background: It is fairly common still to treat Hep C Genotype 3 patients with standard Interferon & Ribavirin. Most patients cannot afford PEG-Interferon in Pakistan. Six months treatment efficacy i.e. end of treatment response is 65 percent with standard interferon for Genotype 3 patients. There is no long-term outcomes data for sustained virological response after standard therapy.

Methods: We carried out retrospective chart review of 350 patients who were treated with standard Interferon thrice weekly and Ribavirin 800 mg daily for 6 months and were HCV PCR negative. The treatment period was between June 2002 to June 2003. We determined their HCVPCR status in July 2006, three years after completion of therapy. 63 patients out of 350 patients (18%) were HCV/PCR positive.

Results: We did univariate and multivariate analysis using logistic regression model. HCVPCR positivity was outcome / dependent variable. Age, gender, body weight, socioeconomic status, and route of HCV transmission were independent / predictive variables. Only patients over age 50, and male gender were statistically significant variables to predict relapse.

Conclusion: This is a very high rate of relapse at 36 months of follow up. This study raises two questions. Efficacy of standard interferon and safety / reliability of HCVPCR as a surrogate marker for disease eradication.

Address for Correspondence:

Prof. Dr. Muzaffar Latif Gill,

Division of Gastroenterology,

Shifa International Hospital-Islamabad-Pakistan.

Treatment outcomes of Chronic Hepatitis C With Genotype 3 Patients With Pegasys Vs Pegintron plus Ribavirin.

Saima Firdoos, Syma Sattar, Yawar Ali, Muzaffar Gill.

Background: PEG-Interferon and Ribavirin is a current treatment of choice for hepatitis C. There are few head to head comparisons in Genotype 3 population especially in Pakistan, so we carried out comparisons between two types of Peg-Interferon.

Methods: Primary efficacy measures were to determine early virological response HCV PCR Negativity at week 4 and end of treatment response by negative HCV PCR at week 24 -.80 patients in each group were enrolled from outpatient, diagnosis was established by HCV antibody & HCV PCR positivity, patients with ALT > 80, genotype 3 were included in the study. Patients who had normal ALT, platelet count less than 75,000, INR greater than 1.5 and portal vein diameter greater than 13 mm were excluded from the study. The peg-interferon alfa –2b group was given 1.5 mcg/kg body weight of pegintron and 800 mg of Ribavirin. Peg-interferon alfa 2a group received 180 mcg of Pegasys and 800 mg of Ribavirin. Treatment duration was 24 weeks for both groups. Patients were followed every 4 weeks.

Results: Two groups were similar in terms of baseline characteristics. 56/80 (70%) patients in PEG-intron group has early virological response HCVPCR negative at week 4 Vs 55/80 (70%) in Pegasys group. 16 out of 80 (20) patients in Pegintron group have HCVPCR negative at week 12 Vs 17 out of 80 (20%) in Pegasys group. 8 (10%) patients in each group have HCV PCR positive at week 12 and treatment was stopped. Incidence of leukopenia was higher in Pegasys group p value = 0.5.

Conclusion: PEG –intron and Pegasys with Ribavirin has equal efficacy. Incidence of leukopenia is more with Pegasys.

Address for Correspondence:

Prof. Muzzaffar Lateef Gill

Division of Gastroenterology

Shifa International Hospital Islamabad-Pakistan.