Republic Of Rwanda Ministry Of Health - : Welcome To RBC

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Republic of RwandaMinistry of HealthJune 2015

FOREWORDViral Hepatitis, caused by the hepatitis B virus (HBV) and hepatitis C virus(HCV) are characterized by the inflammation of liver cells, and may causehepatocellular carcinoma (HCC) and cirrhosis if not treated. HBV and HCVinfections can be either acute or chronic, and their associated illnesses rangein severity from asymptomatic to symptomatic progressive disease stages.Chronic hepatitis B (CHB) and chronic hepatitis C (CHC) are major publichealth problems. According to recent WHO statistics (2015), worldwide,there are an estimated 240 million HBV chronically infected people,particularly in low and middle income countries. Between 20% and 30% ofthose who become chronically infected will develop these complications, andan estimated 650 000 people will die annually due to CHB relatedcomplications.1More than 185 million people around the world have been infected withHCV since 2005, and each year 350 000 die due to CHC relatedcomplications.2The majority of people are unaware of their HBV or their HCV infectionstatus. For those who have been diagnosed, treatment remains inaccessibleand with the current HIV pandemic, viral hepatitis and HIV co-infectionremain a critical disease burden.In terms of HBV prevention, universal HBV immunization programs thattarget new born infants, with the first dose at birth, have been highly effectivein reducing the incidence and prevalence of hepatitis B in many endemiccountries.Additionally, antiviral agents active against HBV are available, and havebeen shown to suppress HBV replication, prevent progression to cirrhosis,and reduce the risk of HCC and liver-related deaths. However, currentlyavailable treatments fail to eradicate the virus in most treated cases,necessitating potentially lifelong treatment.1Hepatitis C infection differs from hepatitis B infection as it can now be curedusing antiviral active treatments. Several medicines are available to treatpeople infected with HCV, and cure rates have steadily improved with theintroduction of newer medicines since 2012.3 These new medications can

cure more than 90% of people with HCV infection and are effective againstgenotypes that were previously difficult to treat.The 2015 edition of the National Guidelines for the prevention andmanagement of Viral Hepatitis B and C were developed in line with therecently published WHO guidelines. The current guidelines thus respond tothe Ministry of Health’s need to improve skills of health care providers aswell as the quality of care and treatment offered in both public and privatehealth facilities countrywide, hence contributing to the improvement of thequality of life of HBV and HCV infected people.The review of the current guidelines would not have been finalized withoutthe esteemed support of all the stakeholders who are involved in the domainof HIV-AIDS and other blood borne infections control in Rwanda.We give our sincere thanks and appreciation to the members of the hepatitistechnical working group and respective organizations that contributed to thedevelopment of this document.Dr. Agnes BINAGWAHOMinister of HealthDr. Agnes BINAGWAHOMinister of Health

LIST OF PARTICIPANTS IN THE ELABORATION OF THE 42526272829303132NameDr. Sabin NsanzimanaDr. Aimable MbituyumuremyiDr. Ribakare MuhayimpunduDr. Emil Ivan MwikaragoDr. Jean Damascene MakuzaDr. Jean Paul UwizihiweDr. Mutagoma MwumvanezaMr. Faustin Machara NzokiraMr. Jean Claude NtirenganyaMr. Emmanuel MutaganzwaMr. Jean Marie Vianney UwimanaMr. Emmanuel NzarambaDr. Tim WalkerDr. Constance MukabatsindaDr. Emmanuel MusabeyezuDr. Jules KabahiziDr. Fabien NtagandaDr. Jules MugaboDr. Philippe MutwaProf. Cyprien BaribwiraDr. Athanase KiromeraDr. Regina OsihMs. Sophie HodderMs. Jeanne UmuhireMr. Benjamin KamarckMs. Anna OsborneDr. Neil GuptaMr. Marc HagenimanaDr. Wellars UwilingiyimanaDr. Diane RusanganwaDr. Felix KayihuraDr. Bitega Jean HAIPIHPIHMEDIPLANRSSBCORARMMI

LIST OF ACRONYMS AND ABBREVIATIONSAFPAlpha Feto-ProteinAIDSAcquired Immuno Deficiency SyndromeALTAlanine aminotransferaseAnti-HBeAntibody to Hepatitis B e antigenAnti-HBsAntibody to the Hepatitis B surface antigenAnti-HCVAntibody to the Hepatitis C VirusAPRIAminotransferase to Platelet Ratio IndexARTAntiretroviral TherapyASSISTAlcohol Smoking and Substance Involvement Screening TestASTAspartate aminotransferaseAUDITAlcohol Use Disorders Identification TestCD4Cluster of Differentiation 4CHBChronic Hepatitis BCHCChronic Hepatitis CCLDChronic Liver DiseaseCrClCreatinine ClearenceDCVDaclatasvirDNADeoxyribonucleic acidELISAEnzyme-Linked Immuno Sorbent AssayGFRGlomerular Filtration RateHbHemoglobinHBeAgHepatitis B Virus Early AntigenHBIgHepatitis B Immune globulinHBs AgHepatitis B surface AntigenHBVHepatitis B VirusHCCHepatocellular Carcinoma

HCVHepatitis C VirusHCWsCommunity Health WorkersHIVHuman immunodeficiency virusIFNInterferonIVDUIntravenous Drug UsersLDVLedipasvirMSMMale having sex with menNATNucleic Acid Amplification TechnologyPCRPolymerase Chain ReactionPWIDPersons Who Inject DrugsRBVRibavirinRNARibonucleic AcidRT-PCRReverse Transcription Polymerase Chain ReactionRVRRapid Virological ResponseSOFSofosbuvirSTIsSexually Transmitted InfectionsSVRSustained Virological ResponseTDFTenofovir Disoproxil FumarateVLViral LoadWHOWorld Health Organization

CONTENTSFOREWORD . iLIST OF PARTICIPANTS IN THE ELABORATION OF THEGUIDELINES. iiiLIST OF ACRONYMS AND ABBREVIATIONS . ivCONTENTS . viList of Tables . viiiList of Figures . viiiPART I:. 1HEPATITIS B MANAGEMENT . 1Chapter I: Overview on Hepatitis B . 21.1.Definitions. 21.2.Transmission of HBV . 31.3.Groups at High Risk of Hepatitis B Infection . 4Chapter II: Hepatitis B Prevention . 5Chapter III: Screening and Diagnosis of Hepatitis B Infection . 11Chapter IV: Management of People with HBV Infection . 144.1. Evaluation of patients with chronic HBV infection . 144.1.3.Assessment of HBV Treatment Eligibility . 154.1.4.Pre-treatment evaluation . 174.2. Education and Preparation for HBV Treatment . 184.3. HBV Treatment Options in Rwanda . 214.4. HBV Management in Special Patient Groups . 224.4.2.Children . 224.4.3.Healthcare Workers . 224.4.4.Chronic HBV infe ning at first contactSymptomaticif not vaccinatedResultsHBsAgHBsAg HBsAgHBsAg HBsAgHBsAg HBsAgHBsAg InterventionProvide Vaccine and check HBs AbRefer to care and treatmentProvide Vaccine and check HBs AbRefer to care and treatmentProvide Vaccine and check HBs AbRefer to care and treatmentProvide Vaccine and check HBs AbRefer to care and treatment

Chapter IV: Management of People with HBV Infection4.1. Evaluation of patients with chronic HBV infection4.1.1.The Initial EvaluationThis baseline evaluation includes:History and physical examinationFamily history of liver disease, hepatocellular carcinoma (HCC)Lifestyle assessment with focus on alcohol consumption and dietLaboratory tests to assess liver fibrosis (AST, ALT, Platelets)Tests to rule out viral co-infections (Anti-HCV, Anti-HIV )Tests to screen for HCC-Alpha fetoprotein (AFP) in high risk patients-Ultrasound at baseline if available4.1.2.Liver Fibrosis Assessment by Non –Invasive TestsAspartate aminotransferase (AST)-to-Platelet Ratio Index (APRI) is a simpleindex for estimating hepatic fibrosis based on a formula derived from AST andplatelet concentrations.11For the purpose of early initiation of patients on therapy, the cutoff of 1.0should be considered. Below is the formula to be used for APRI Score:APRI Score and Liver Fibrosis Assessment FormulaAST LevelAPRI AST (Upper Limit of Normal)Platelets Count (109)/Lx 100NB: In this formula, 3 zeros in platelets count are chopped off.Example, if you have 137,000 platelets, you only consider 137An online calculator can be found at: tors/apri

Table 3: Interpretation of Aminotransferase Platelet Ratio Index (APRI)APRI ValueInterpretationAction 1High Probability (94%) of F4 CirrhosisPrioritize for treatment 1Risk of Advanced FibrosisConsider for treatment4.1.3.Assessment of HBV Treatment EligibilityAs a priority, all patients with chronic hepatitis B (CHB) and clinicalevidence of compensated or decompensated cirrhosis (or cirrhosis basedon APRI score in adults) should be treated, regardless of HBeAg status,ALT or HBV DNA levels1All HIV-HBV co-infected people are eligible to TDF-based regimen forlifeTreatment is also recommended for adults with CHB who do not haveclinical evidence of cirrhosis (or based on APRI scores), but are aged morethan 30 years, and have persistently abnormal ALT levels or and evidenceof high-level HBV replication (HBV DNA 20 000 IU/mL)1 as shown byfigure 2

Figure 2: Diagnosis of HBV and Treatment Eligibility CriteriaHIV &HBsAg TestHIV HBsAg-HIV- HBsAg-HIV- HBsAg HIV HBsAg Vaccination &Refer to ARTserviceHBVVaccinationClinicalCirrhosis ORAPRI 1.0Start TDF basedARTNoYesALT 30 IU/mLALT 30 IU/mL1. Ultrasound to rule out other causes2. Stop offending drugs /alcohol3. Recheck ALT4. Consider specialist referral5. Repeat HBsAg at 6 months6. Repeat HIV test at 6 monthsConsider forHBV TherapyAbnormalALTLikelyadherent*YesMajor co-morbidityor CrCl 60ml/minNoStartTDF300mgYesConsult nlikelyadherentNormalizedALTMonitorevery 12M:1. ALTelevation2. ClinicalCirrhosis3. APRIAge 30 & HBVDNA 20,000 IU/mLNoYesConsider forHBV Therapy*Ability to return,willingness to treatment forlife, and life stylemodifications (alcohol, diet)

4.1.4.Pre-treatment evaluationThis includes:Tests to rule out viral co-infections-Anti-HCV-Anti-HIVTests to screen for HCC-Alpha fetoprotein (AFP) in high risk patients,-Ultrasound at baseline if availableRenal Function Test-Creatinine-Creatinine Clearance (or GFR)Education for lifestyle and dietCounseling for adherence4.1.5.Calculation of Creatinine ClearanceThe Cockcroft Formula is used to calculate the glomerular filtration rate(GFR) or Creatinine Clearance expressed in mL/min as follows:If Creatinine machine reports in mg/dL(140-Age)x Weight (Kg)CrCl x 0.85

HBeAg Hepatitis B Virus Early Antigen HBIg Hepatitis B Immune globulin HBs Ag Hepatitis B surface Antigen HBV Hepatitis B Virus HCC Hepatocellular Carcinoma Y _ 3DJH 9LUDO HSDWLWLV % DQG & *XLGHOLQHV HCV Hepatitis C Virus HCWs Community Health Workers HIV Human immunode

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