efficacy of mass hepatitis-b immunization programme in andhra pradesh

2
Background: There is rapid emergence of HBV resistance against lamivudine when it is used as a sole HBV-active agent in antiretroviral regimen among HIV/HBV co-in- fected patients. The preferred regimen for such dually in- fected patients is tenofovir + lamivudine + efavirenz. The aim of this ICMR-supported study was to assess whether addition of adefovir to the antiretroviral regimen of zido- vudine/stavudine + lamivudine + efavirenz could be a suit- able alternative with favorable HBV virologic outcome and reduction of drug-resistant mutants, so that tenofovir can be reserved as a dually-active agent for secondline ART. Objectives: To ascertain the anti-HBV activity of tenofovir + lamivudine compared to adefovir + lamivudine in sup- pressive antiretroviral regimen among HIV/HBV co-in- fected subjects. Methods: Seventy-four HIV/HBV co-infected patients, enrolled in the ART Centre of Calcutta School of Tropical Medicine, were randomized to receive tenofovir + lamivu- dine + efavirenz or adefovir + zidovudine/stavudine + lamivudine + efavirenz. CD4 count, LFT, prothrombin time, platelet count, HBeAg, anti-HBe, HBV DNA quanti- cation (by nested-PCR amplication) were done and at baseline and repeated at 6 months. HBV genotyping and measurement of plasma HIV-1 RNA was done at baseline. Results: Median age of study participants was 35 years (range 2162 years). Genotype HBV/D (71.7%) was the pre- dominant genotype followed by HBV/A (19.4%) and HBV/ C (8.9%). There was no statistical difference in baseline me- dian haemoglobin (11.9 vs. 10.9 gm/dL), ALT (41 vs. 38 IU/L), AST (47 vs. 41 IU/L), platelet count (163 x 10 3 vs.172 x 10 3 mm 3 ), APRI (0.81 vs 0.8), CD4 count (206 vs. 198 cells/mm 3 ), HIV RNA (5.0 vs. 4.88 log 10 copies/ mL), HBV DNA (4.8 vs. 7.4 x 10 4 IU/mL) between adefovir and tenofovir arms respectively. Prothrombin time was signicantly higher in tenofovir group (12.01 vs. 11.1 sec- onds; P = 0.01). HBeAg positivity was 48.9% (22/45) and 51.1% (23/45) on adefovir and tenofovir respectively. Following 6 months of treatment HBV DNA became unde- tectable in 77.4% (24/31) and 82.7% (24/29) of patients in adefovir and tenofovir arm respectively (P = 0.5). A loss of HBe-antigen was observed in 12.5% (2/16) and 17.6% (3/17) in adefovir and tenofovir arm respectively at 6 months of treatment. ALT normalization (12/16; 75% vs. 6/14; 43%, P = 0.2) rate and median rise of CD4 count (130 vs. 177cells/mm 3 , P = 0.4) were similar in adefovir and tenofovir-based regimens. Conclusion: Prolonged follow-up is needed to decide on the superiority of tenofovir/lamivudine or adefovir/lami- vudine as HBV-active component in antiretroviral regi- mens in HIV/HBV co-infected patients. All the study subjects are being followed up for 18 months. Corresponding author: Jayeeta Sarkar. Email: [email protected] EFFICACY OF MASS HEPATITIS-B IMMUNIZATION PROGRAMME IN ANDHRA PRADESH Murali Krishna Palakurthy*, Chaitanya Koppolu*, Ravi Shankar Yalamarty y , Girinadh Lekkala*, Sowjanya Pillela*, Anisha Vupputuri* * Department of Gastroenterology, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India, and y Department of Gastroenterology Medicine, Andhra Medical College, Visakhapatnam, Andhra Pradesh, India Background: Hepatitis-B infection is a global health prob- lem with 2 billion people infected worldwide. The imple- mentation of mass immunization programs following the recommendation by the WHO in 1991 has dramati- cally decreased the incidence of HBV infection among in- fants, children, and adolescents in many countries. However, not all countries have adopted these recommen- dations. In India Universal Immunization against Hepati- tis-B is practiced only in 10 states (It is practiced in Andhra Pradesh whereas in Orissa it is not). Currently there are no well articulated and authentic studies to evaluate the ef- cacy of immunization programme against Hepatitis-B. Aim: The aim of the study is to compare the prevalence of protective level of antibodies against HBV between chil- dren from universal immunization region and non-immu- nized region. Methods: It is a cross sectional study conducted at Visa- khapatnam between 2010 and 2011. Serum samples were taken from children below 8 years of age (as universal im- munization began in 2002 in Andhra Pradesh) visiting our hospital due to illness unrelated to liver, after obtaining consent from their parents. One Hundred serum samples were collected from children belonging to Andhra Pradesh and 100 from children belonging to Orissa. Subjects posi- tive for Hepatitis-B surface antigen (HBsAg) were excluded. Antibody levels against Hepatitis B surface antigen (Anti HBsAg) were estimated in both the groups. The protective levels of the antibodies are compared in both the groups (>10m IU/ml). Results: Out of 100 children belonging to Orissa, only 24 had protective level of antibodies and 76 did not have pro- tective level of antibodies against HBsAg. Out of 100 chil- dren belonging to Andhra Pradesh 85 had protective levels of Anti-HBsAg antibodies and only 15 did not have protec- tive levels. Conclusion: Universal immunization against hepatitis-B in Andhra Pradesh is effective in producing protective level of antibodies against HBV in the majority of subjects. However, further studies are needed to evaluate the bene- ts of immunization in reducing the total disease burden related to HBV. JOURNAL OF CLINICAL AND EXPERIMENTAL HEPATOLOGY Journal of Clinical and Experimental Hepatology | March 2014 | Vol. 4 | No. S2 | S6S29 S17 Viral Hepatitis

Upload: anisha

Post on 02-Jan-2017

214 views

Category:

Documents


2 download

TRANSCRIPT

Page 1: Efficacy of Mass Hepatitis-B Immunization Programme in Andhra Pradesh

JOURNAL OF CLINICAL AND EXPERIMENTAL HEPATOLOGY

ViralH

epatitis

Background: There is rapid emergence of HBV resistanceagainst lamivudine when it is used as a sole HBV-activeagent in antiretroviral regimen among HIV/HBV co-in-fected patients. The preferred regimen for such dually in-fected patients is tenofovir + lamivudine + efavirenz. Theaim of this ICMR-supported study was to assess whetheraddition of adefovir to the antiretroviral regimen of zido-vudine/stavudine + lamivudine + efavirenz could be a suit-able alternative with favorable HBV virologic outcome andreduction of drug-resistant mutants, so that tenofovir canbe reserved as a dually-active agent for secondline ART.Objectives: To ascertain the anti-HBV activity of tenofovir+ lamivudine compared to adefovir + lamivudine in sup-pressive antiretroviral regimen among HIV/HBV co-in-fected subjects.Methods: Seventy-four HIV/HBV co-infected patients,enrolled in the ART Centre of Calcutta School of TropicalMedicine, were randomized to receive tenofovir + lamivu-dine + efavirenz or adefovir + zidovudine/stavudine +lamivudine + efavirenz. CD4 count, LFT, prothrombintime, platelet count, HBeAg, anti-HBe, HBV DNA quanti-fication (by nested-PCR amplification) were done and atbaseline and repeated at 6 months. HBV genotypingand measurement of plasma HIV-1 RNA was done atbaseline.Results: Median age of study participants was 35 years(range 21–62 years). Genotype HBV/D (71.7%) was the pre-dominant genotype followed by HBV/A (19.4%) and HBV/C (8.9%). There was no statistical difference in baseline me-dian haemoglobin (11.9 vs. 10.9 gm/dL), ALT (41 vs. 38IU/L), AST (47 vs. 41 IU/L), platelet count (163 x 103

vs.172 x 103 mm3), APRI (0.81 vs 0.8), CD4 count (206vs. 198 cells/mm3), HIV RNA (5.0 vs. 4.88 log10 copies/mL), HBV DNA (4.8 vs. 7.4 x 104 IU/mL) between adefovirand tenofovir arms respectively. Prothrombin time wassignificantly higher in tenofovir group (12.01 vs. 11.1 sec-onds; P = 0.01). HBeAg positivity was 48.9% (22/45) and51.1% (23/45) on adefovir and tenofovir respectively.Following 6months of treatment HBVDNA became unde-tectable in 77.4% (24/31) and 82.7% (24/29) of patients inadefovir and tenofovir arm respectively (P = 0.5). A lossof HBe-antigen was observed in 12.5% (2/16) and 17.6%(3/17) in adefovir and tenofovir arm respectively at6 months of treatment. ALT normalization (12/16; 75%vs. 6/14; 43%, P = 0.2) rate and median rise of CD4 count(130 vs. 177cells/mm3, P = 0.4) were similar in adefovirand tenofovir-based regimens.Conclusion: Prolonged follow-up is needed to decide onthe superiority of tenofovir/lamivudine or adefovir/lami-vudine as HBV-active component in antiretroviral regi-mens in HIV/HBV co-infected patients. All the studysubjects are being followed up for 18 months.

Corresponding author: Jayeeta Sarkar.Email: [email protected]

Journal of Clinical and Experimental Hepatology | March 2014 | Vol. 4 | No

EFFICACY OF MASS HEPATITIS-BIMMUNIZATION PROGRAMME INANDHRA PRADESH

Murali Krishna Palakurthy*, Chaitanya Koppolu*,Ravi Shankar Yalamartyy, Girinadh Lekkala*,Sowjanya Pillela*, Anisha Vupputuri*

*Department of Gastroenterology, Andhra Medical College,Visakhapatnam, Andhra Pradesh, India, and yDepartment ofGastroenterology Medicine, Andhra Medical College,Visakhapatnam, Andhra Pradesh, India

Background:Hepatitis-B infection is a global health prob-lem with 2 billion people infected worldwide. The imple-mentation of mass immunization programs followingthe recommendation by the WHO in 1991 has dramati-cally decreased the incidence of HBV infection among in-fants, children, and adolescents in many countries.However, not all countries have adopted these recommen-dations. In India Universal Immunization against Hepati-tis-B is practiced only in 10 states (It is practiced in AndhraPradesh whereas in Orissa it is not). Currently there are nowell articulated and authentic studies to evaluate the effi-cacy of immunization programme against Hepatitis-B.Aim: The aim of the study is to compare the prevalence ofprotective level of antibodies against HBV between chil-dren from universal immunization region and non-immu-nized region.Methods: It is a cross sectional study conducted at Visa-khapatnam between 2010 and 2011. Serum samples weretaken from children below 8 years of age (as universal im-munization began in 2002 in Andhra Pradesh) visiting ourhospital due to illness unrelated to liver, after obtainingconsent from their parents. One Hundred serum sampleswere collected from children belonging to Andhra Pradeshand 100 from children belonging to Orissa. Subjects posi-tive for Hepatitis-B surface antigen (HBsAg) were excluded.Antibody levels against Hepatitis B surface antigen (AntiHBsAg) were estimated in both the groups. The protectivelevels of the antibodies are compared in both the groups(>10m IU/ml).Results: Out of 100 children belonging to Orissa, only 24had protective level of antibodies and 76 did not have pro-tective level of antibodies against HBsAg. Out of 100 chil-dren belonging to Andhra Pradesh 85 had protective levelsof Anti-HBsAg antibodies and only 15 did not have protec-tive levels.Conclusion: Universal immunization against hepatitis-Bin Andhra Pradesh is effective in producing protective levelof antibodies against HBV in the majority of subjects.However, further studies are needed to evaluate the bene-fits of immunization in reducing the total disease burdenrelated to HBV.

. S2 | S6–S29 S17

Page 2: Efficacy of Mass Hepatitis-B Immunization Programme in Andhra Pradesh

ABSTRACTS 22ND ANNUAL CONFERENCE–2014

Vira

lHep

atitis

Corresponding author: Murali Krishna Palakurthy.Email: [email protected]

TREATMENT OF CHRONIC HEPATITIS CGENOTYPE 1 WITH PEGYLATEDINTERFERONANDRIBAVIRIN FOR 36WEEKSIN PATIENTS WITH EARLYVIROLOGICAL RESPONSE

Ajit Sood*, VandanaMidhay, Omesh Goyal*, Neena Soodz,Suresh Sharmax

*Department of Gastroenterology, DMC and Hospital, Ludhiana,Punjab, India, yDepartment of Medicine, DMC and Hospital,Ludhiana, Punjab, India, zDepartment of Pathology, DMC andHospital, Ludhiana, Punjab, India, and xDepartment ofCommunity Medicine, DMC and Hospital, Ludhiana, Punjab,India

Background and Aims: Standard treatment for patientswith chronic hepatitis C genotype 1 (CHC G-1) infectionincludes pegylated interferon plus ribavirin (PEG-RBV)for 48 weeks. Twenty-four weeks therapy is equally effectivebut in a small sub-group of patients who have both lowviral load and achieve rapid virological response (RVR).This prospective study aimed to compare efficacy of ashorter 36 weeks therapy with standard 48 weeks therapyin CHC G-1 patients who achieve complete early virolog-ical response (cEVR).Methods: Consecutive patients of CHC G-1 patientstreated with PEG-RBV who achieved cEVR at 12 weeks (un-detectable HCV RNA irrespective of 4 week response) wererandomized into 2 groups- group A (48 weeks therapy) andgroup B (36 weeks therapy). Primary end-point wasachievement of sustained virological response (SVR) at24 weeks of follow up.Results: Of total 166 patients with CHC G1 started ontreatment, 112 (69.3%) achieved cEVR. They were random-ized into group A (n = 59) and group B (n = 53) (baselinecharacteristics comparable). In group A, 55 patients(90%) completed therapy and 2 had severe adverse events.In group B, 50 patients (92.5%) completed therapy andone had severe adverse event. The SVR rates in group Aand B were similar [85.5% (47/55) vs. 90% (45/50); P =ns]. Factors like viral load, RVR, age, BMI and advancedfibrosis did not influence the SVR rate.Conclusion: In CHC G-1 patients who achieve cEVR, 36weeks of therapy with PEG-RBV is as effective as standard48 weeks therapy, irrespective of other host or virologicalfactors.

Corresponding author: Ajit Sood.Email: [email protected]

S18

IS THERE A ROLE FOR IL-18 IN HOSTDEFENSE AGAINST HBV INFECTION?

Vijay Kumar Karra*, Phani Kumar Gumma*,Rajesh Ruttala*, Soumyajyothi Chowdhary*,Sunil Kumar Pollipalli*, Anitha Chakrvarthiy,Premashis Kar*

*Department of Medicine, Maulana Azad Medical College, NewDelhi, India, and yDepartment of Microbiology, Maulana AzadMedical College, New Delhi, India

Aim: To investigate the polymorphisms of interleukin-18(IL-18) gene promoters, and to disclose whether such poly-morphisms are associated with susceptibility to HBV infec-tion from North Indian population.Materials & Methods: IL-18 gene promoters polymor-phism in 134 acute hepatitis B, 48 chronic hepatitis B, 84liver cirrhosis, 24 hepatocellular carcinoma (HCC) patientsand 280 healthy controls were analyzed by using the poly-merase chain reaction/sequence specific primer (PCR/SSP)technique from New Delhi.Results: The frequency of the CC genotype at -607 wassignificantly higher in HBV cases 53 (18.2%) comparedwith that in the healthy controls 19 (6.7%) (odds ratio[OR], 3.072; 95% confidence interval [CI], 1.767, 5.339,c2 = 17.04 , P < 0.05), 12 (8.9%) acute hepatitis B had theCC genotypes, 77 (57.4%) had the AC genotype, and 45(33.5%) had the AA genotype. in chronic hepatitis B group,2 (4.1%) had the CC genotype, 36 (75.0%) had the AC geno-type, and 10 (20.8%) had the AA genotype. in HBV relatedcirrhosis group, 34 (40.4%) had the CC genotype, 38(45.2%) had the AC genotype, and 12 (14.2%) had the AAgenotype. and in the HCC group 5 (20.8%) had the CC ge-notype, 17 (70.8%) had the AC genotype, 2 (8.3%) had theAA genotype. And the frequency of the AA genotype wassignificantly lower in HBV cases 69 (23.7%) comparedwith that in the healthy controls 108 (38.5%) (oddsratio [OR], 0.4972; 95% confidence interval [CI], 0.3463,0.714, c2 = 14.53 , P < 0.05). But in phenotypes, the alleleA at -607 was of a significantly higher frequency in thehealthy control than that in the HBV patients (c2 =20.35, P < 0.05). at -137 position 147 (50.6%) HBV patientshad GG genotype than 159 (56.7%) in healthy control, and128 (44.1%) HBV patients had GC genotype than 108(38.5%) in healthy control, and 15 (5.1%) HBV patientshad CC genotype than 13 (4.6%) in healthy control. No sig-nificant difference was observed.Conclusion: The polymorphisms of the promoter re-gion of IL-18 gene at position -607 and -137 are closelyassociated with susceptibility to HBV infection. CC ge-notype at position -607 may be closely associated withHBV infection, moreover the people with allele A at

© 2014, INASL