Professor Vincent Soriano

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1 Five Nations Conference on HIV and Hepatitis in partnership with Professor Vincent Soriano Hospital Carlos III, Madrid, Spain Professor Vincent Soriano in partnership with Hospital Carlos III, Madrid, Spain COMPETING INTEREST OF FINANCIAL VALUE > 1,000 Statement None Date: December 2015

2 What s new in HIV & HBV Co-Infection? Vicente Soriano Infectious Diseases Unit La Paz University Hospital & IdiPAZ, Madrid, Spain HIV/HBV Outline Epidemiology & natural history re-visited Treatment issues Flares, acute-on-chronic, co-infections

3 Hepatitis B in million chronic carriers worldwide (WHO) Hyper-endemic areas in Southeast Asia and Sub-Saharan Africa Oral nucleos(t)ide therapy is effective in most pts, but viral eradication is not feasible. When tenofovir is not available, prevention and management of LAM resistance requires expertise. Given the long asymptomatic period, late diagnosis is common. Despite effective vaccine for 30 years, there is continuous flow of incident cases (immigrants, non-responders, etc) Favorable outcome following liver transplantation HBV genotypes (8) Genotype Region Comments A Northern America More sensitive to IFN Northern Europe ALT more frequently India, Africa More rapid 3TC resistance B Asia More benign More sensitive to IFN C Asia More HCC; more resistance D Southern Europe Less response to IFN Middle East, India E West & South Africa F Central & South America G USA and Europe H Central America, California Kramvis et al. J Viral Hepat 2005; 12: Schaefer et al. Hepatol Res 2007; 37 (suppl): 20-6.

4 Natural history of HBV infection & effect of HIV Acute hepatitis B Anti-HBs Anti-HBc Chronic HBsAg HIV Anti-HBe HBV-DNA neg HBeAg HBV-DNA pos Cirrhosis Liver decompensation Liver cancer Immune response Progressive disease HIV enhances chronic HBV disease Higher serum HBV-DNA ( 1 log on average) More rapid liver fibrosis progression. More frequent selection of drug resistance. Less frequent spontaneous HBsAg or HBeAg seroconversion More frequent coinfection with HCV and/or HDV. Increased mortality.

5 HBV Negatively Impacts on HIV Disease Progression Thio et al. Lancet 2002; 360: MSM from the MACS cohort 213 HIV+/HBsAg+, 113 HIV-/HBsAg+ & 2346 HIV+/HBsAg- Liver-related mortality was greater in coinfected patients than in HIV alone (>8-fold) or HBsAg alone (>16-fold) Non-liver deaths more frequent in HBsAg+ with low nadir CD4 Chun et al. JID 2012; 205: HIV seroconverters in the United States Hazard ratio of 1.8 for AIDS/death in HBsAg+ vs HBsAg- Dore et al. AIDS 2010; 24: HIV+/HBsAg+ patients from the SMART study HBV-DNA rebound following ART interruption is associated with faster CD4 decline Time to antiretroviral therapy re-initiation in the DC arm Non-HBV/HCV: Among 5472 participants, 930 (17%) were hepatitis co-infected [HBsAg+ (n=120, 2.2%); and HCVAb+ (n=796, 14.5%). SMART. AIDS 2010; 24:

6 Therapeutic Agents Available for HBV PEG-Interferon Lamivudine (Adefovir) Entecavir Telbivudine Emtricitabine Tenofovir Incidence of HBV Resistance Lamivudine (rtl180m+rtm204v/i) Adefovir (rtn236t/rta181v) Incidence of Resistance 80% 70% 60% 50% 40% 30% 20% 10% 0% Telbivudine 70% 53% 42% 24% 18% 11% 3% 0% year 1 year 2 year 3 year 4 29% year 5 75% Lai C et al. Clin Infect Dis 2003; 36:

7 Consequences of selecting HBV drug resistance Loss of clinical benefit. Cross-resistance with other antivirals. Transmission of HBV resistant variants. Selection of HBV vaccine escape mutants (occult infections and lack of protective effect of HBV vaccine). Shouval & Locarnini Gastroenterology 2012; 143: Transmission of HBV vaccine escape mutants HBsAg LAM HBsAg Mutant HBsAg se164d, si195m HBV-DNA M204V V173L L180M M204V Wild type HBV LAM-resistant HBV LAM-resistant, vaccine escape mutant HBV

8 EACS guidelines Risk of cirrhosis in HBsAg+ patients (REVEAL, n=3582) RR % 365 cases of cirrhosis over 11 years Adjusted for gender, ALT, alcohol and smoking HBsAg- (18,541) < >10 6 HBV-DNA copies/ml Iloeje et al. Gastroenterology 2006;130:

9 HR Risk of HCC in HBsAg+ patients (REVEAL, n=3584) 184 cases of HCC over 12 years Adjusted for gender, ALT, alcohol and smoking HBsAg- (18,541) < >10 6 HBV-DNA copies/ml Chen et al. JAMA 2006; 245: New challenges HBV therapeutics in 2014 Tenofovir toxicity (kidney, bone) High cost of tenofovir Tenofovir drug interactions (HIV, HCV) Tenofovir failures (entecavir intensification?)

10 Management of tenofovir toxicity for chronic hepatitis B 1. TDF dose reduction 2. Entecavir 3. TAF (TDF prodrug) 4. Lamivudine Tenofovir for chronic hepatitis B Plaza et al. AIDS 2013; 27:

11 Virological response to tenofovir in patients with detectable HBV-DNA according to HIV and HBeAg status Plaza et al. AIDS 2013; 27: TDF for HBV - Summary The antiviral efficacy of tenofovir is similar in HIV/HBVcoinfected and HBV-monoinfected patients. Nearly 90% of baseline viremic patients achieve undetectable HBV-DNA on tenofovir at week 96. Baseline serum HBV-DNA is the major determinant of virological response. There is no significant influence of HBeAg, drug resistance mutations nor coinfection with hepatitis C or delta. Plaza et al. AIDS 2013; 27:

12 Time free from liver decompensation events or death in 1138 HIV+ patients Patients (%) 100 HIV-monoinfected (n=524) HIV/HCV-coinfected with SVR (n=106) HIV/HCV spontaneous clearance (n=21) HIV/HBV-coinfected (n=85) HIV/HCV untreated (n=258) HIV/HCV non-responders (n=127) HIV/delta (n=17) 90 p=0.002 p< p< Months Fernandez et al. Clin Infect Dis 2014; 58: Acute-on-Chronic Liver Failure due to HBV Severe exacerbation of liver damage in patients with underlying chronic hepatitis B and no cirrhosis that may lead to liver failure and death. Criteria ALT >20 ULN Bilirubin >5 ULN Prothrombin time <60% Etiology HBeAg seroconversion HBsAg seroconversion HBV drug resistance emergence HBV reactivation following chemotherapy

13 Hepatitis B flares Liver enzyme elevations in patients with known chronic hepatitis B Delta super-infection HAV, HCV or HEV super-infection Drug-related hepatotoxicity Immune reconstitution with ARV Acute alcohol intake HBV HCV dual infections in HIV 21 HIV / HBsAg+ / HCV Ab+ patients exposed to treatment for either HBV or HCV. Soriano et al. J Infect Dis 2007; 195:

14 Summary HBV markers must be tested at baseline in all HIV+ persons. HBV vaccination must be given to those with neg markers. Chronic hepatitis B progresses faster in HIV. It increases the risk of hepatotoxicity using ARVs. Treatment of HBV should be considered as a priority in HIV+ pts. All HBV/HIV patients should be tested for viral load, genotype and liver fibrosis generally assessed by non-invasive tools. Avoid 3TC (FTC) as only anti-hbv agent up front. HBV treatment plan should be individualized, based on the need for HIV treatment and prior 3TC therapy. Stop and regression of advanced liver fibrosis can be seen with prolonged sustained suppression of HBV replication. Exclude delta hepatitis in all HBsAg+ patients. Treat active replicating virus in HBV-HCV dually infected patients. Acknowledgments Pablo Barreiro, IdiPAZ & La Paz University Hospital, Madrid Antonio Aguilera, Hospital Conxo - CHUS, Santiago Eva Poveda, Inibic - Complexo Hospitalario, A Coruña Carmen Rodríguez & Jorge del Romero, Centro Sandoval, Madrid Carmen de Mendoza, Puerta de Hierro Research Institute, Madrid Pablo Labarga, La Luz Clinic, Madrid Jose V. Fernandez-Montero, University Hospital Crosshouse, Kilmarnock, Scotland, UK

15 HBV HIV DNA RNA RT DNA RNA RT RNA Provirus Nucleus HCV cccdna Hepatocyte CD4+ T lymphocyte Pol RNA RNA Cytosol Nucleus Hepatocyte J Antimicrob Chemother 2008;62:1-4. [HBsAg] measurement Advantages: Cheap Easy to perform (ELISA) Early decay on treatment associated with clearance Disadvantages: Poor correlation with HBV-DNA

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