Global Prevalence of HBV, HCV, HIV

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1 Treatment of Patients with HCV and HIV Paul Y. Kwo, MD, FACG Professor of Medicine Stanford University Global Prevalence of HBV, HCV, HIV 24 m Journal of Clinical Virology Page 1 of 15

2 Hepatitis C is Underdiagnosed in US 5,, 4,, Number infected 3,, 2,, Undiagnosed Diagnosed ~75% 1,, ~21% ~65% HIV HBV HCV HIV=human immunodeficiency virus; HBV=hepatitis B virus; HCV=hepatitis C virus Institute of Medicine. Hepatitis and Liver Cancer: A National Strategy for Prevention and Control of Hepatitis B and C; 21. HEPATOLOGY215;62: ) Mortality Rates from HBV, HCV, and HIV in United States, Ly KN, et al. Ann Intern Med. 212;156(4): Page 2 of 15

3 Hepatitis C Differs from HIV and HBV No long-term or Latent Reservoir HBV HIV HCV Host cell Viral RNA cccdna Proviral DNA Host DNA Nucleus TREATMENT TREATMENT Long-term suppression of Long-term viral replication suppression of viral replication 2,3 cccdna = covalently closed circular DNA TREATMENT Viral Eradication = Cure 1. Pawlotsky JM. J Hepatol 26;44:S1-S13; 2. Siliciano JD, Siliciano RF. J Antimicrob Chemother 24;54:6-9; 3. Lucas GM. J Antimicrob Chemother 25;55: HIV v HCV HIV HCV Virus Retrovirus Flavivirus Transmission Sex > Blood Blood > Sex Viremia High (1 9 virons/day) Higher (1 12 virons/day) Target Cells Lymphoid (CD4) Hepatocytes Mutations Frequent Reverse transcriptase (RNA- DNA) Frequent RNA polymerase (RNA-RNA) Time to Clinical Illness Years Decades Nuclear Reservoir Yes No (cytoplasmic) Curable 1 cure after BMT >95% Page 3 of 15

4 HCV/HIV Co-Infection Outbreak in Indiana 84% Co-infected with HCV Page 4 of 15

5 HCV Co-Infection in HIV+ MSM HIV CD4 Viral Load Multiple Partners Sexual Practices Other STDs SEX Crystal methamphet amines DRUGS Martinello CROI 216 Lachowsky CROI 216 Enhanced fibrosis in HCV/HIV Co-Infection Chen Nat Rev Gastroenerol Hepatol. Page 5 of 15

6 HCV Treatment and Incidence of ESLD, HCC, and Death Prospective US cohort ( ) (n=638) Liver biopsy at baseline Survival Free of ESLD, HCC, or Death 35% underwent HCV treatment with PR Baseline >F2 versus <F2 fibrosis Higher treatment rates: 54% versus 28% (P<.1) Similar SVR rates: 17% versus 16% No clinical events (ESLD, HCC, and death) among patients achieving SVR Limketkai BN, et al. JAMA. 212;38: Cumulative Survival No HCV treatment SVR Relapse Log-rank P=.5 Nonresponse Time Since Biopsy (years) Check for drug-drug interactions (DDI) between HCV and HIV drugs! Drug interactions List of CYP substrates, inhibitors, inducers HIV drug interactions Khoo S. 15th International Workshop on Clinical Pharmacology of HIV & Hepatitis Therapy, May 214 [oral presentation]. CYP, cytochrome Page 6 of 15

7 Drug Interactions Between Select ARTs and HCV Therapies DCV LED/ SOF OBV/ PTV/r OBV/ PTV/r +DSV EBV/ GZR SOF/ VEL SMV SOF Integrase Inhibitors Raltegravir D 2% E2% E134% Dolutegravir E38% 11% E8% 5% D27% NRTIs 36/78 Elvitegravir/cobicistat E Abacavir Emtricitabine 6% Lamivudine Tenofovir Zidovudine 1% E1% E These drugs should not be coadministered 14% E18% 6% = potential decreased exposure of DAA; = potential increased exposure of DAA; D = potential decreased exposure of ARV; E = potential elevated exposure of ARV. Potential interaction may require dosage adjustment or close monitoring 13 No clinically significant interaction expected Drug Interactions Between Select ARTs and HCV Therapies DCV LED/ SOF OBV/ PTV/r OBV/ PTV/r +DSV EBR/ GZR SOF/ VEL SMV SOF NNRTIs Efavirenz 32% -/34% Severe* Severe* 71% 6% D4% Etravirine E? E? Nevirapine E? E? Rilpivirine E E Entry Inhibitor Maraviroc E? E E 6% E12% 9% E6% = potential decreased exposure of DAA; = potential increased exposure of DAA; D = potential decreased exposure of ARV; E = potential elevated exposure of ARV. ART = antiretroviral therapy; BOC = boceprevir; DCV = daclatasvir; LED = ledipasvir; OBV/PTV/r + DSV = ombitasvir/paritaprevir/ritonavir + dasabuvir; SMV = simeprevir; SOF = sofosbuvir; TVR = telaprevir; Peg IFN = pegylated interferon; RBV = ribavirin. 1. European AIDS Clinical Society (EACS) Guidelines Version 8., Updated October 215. Available at: Accessed October 25, 215. These drugs should not be coadministered Potential interaction may require dosage adjustment or close monitoring 14 No clinically significant interaction expected Page 7 of 15

8 Drug Interactions Between Select ARTs and HCV Therapies DCV LED/ SOF OBV/ PTV/r OBV/ PTV/r +DSV EBR/ GZR SOF/ VEL SMV SOF Protease Inhibitors Atazanavir/ritonavir 11% 8/113% 94% Darunavir/cobicistat E Darunavir/ritonavir 4% 34/39% D 34% Lopinavir/ritonavir 15% = potential decreased exposure of DAA; = potential increased exposure of DAA; D = potential decreased exposure of ARV; E = potential elevated exposure of ARV. These drugs should not be coadministered ART = antiretroviral therapy; BOC = boceprevir; DCV = daclatasvir; LED = ledipasvir; Potential interaction may require dosage adjustment or close monitoring OBV/PTV/r + DSV = ombitasvir/paritaprevir/ritonavir + dasabuvir; SMV = simeprevir; SOF = sofosbuvir; 15 TVR = telaprevir; Peg IFN = pegylated interferon; RBV = ribavirin. No clinically significant interaction expected TURQUOISE-I: Paritaprevir/r + Ombitasvir + Dasabuvir + RBV (3D + RBV) 3D + RBV 3D + RBV SVR12 SVR12 Phase 2/3 HCV Genotype 1 6 HIV-1 Included HCV treatment-naïve, treatment-experienced, 4 cirrhotic and non-cirrhotic patients 3D: Co-formulated Paritaprevir/ritonavir/ombitasvir, 15 mg/ 1 2 mg/ 25 mg + dasabuvir, 25 mg RBV: 1-12 mg daily, weight-based n=31 32 Patients on atazanvir for HIV were instructed to discontinue their stand-alone ritonavir during 3D therapy Weeks Weeks 2 patients in the 24-week group had re-infection, not relapse. Wyles D et al.hepatology. 214;6(suppl): Abstract 1939 SVR12, % Patients Page 8 of 15

9 ION-4: LDV/SOF in HIV/HCV Phase 3, multicenter, open-label study in US, PR, Canada, and New Zealand Wk Wk 12 Wk 24 GT 1 and 4 TN and TE N=335 LDV/SOF SVR12 Broad inclusion criteria Platelets 5,/mm 3 ; hemoglobin 1 g/dl, CrCl 6 ml/min HIV-1 positive, HIV RNA <5 copies/ml; CD4 cell count >1 cells/mm 3 Mean age, y (range) 52 (26-72) Male, n (%) 276 (82) Black, n (%) 115 (34) Hispanic or Latino, n (%) 56 (17) Mean BMI, kg/m 2 (range) 27 (18-66) IL28B CC, n (%) 81 (24) GT 1, n (%) 327 (98) HCV treatment experienced, n (%) 185 (55) Cirrhosis, n (%) 67 (2) Naggie et al, CROI 215, Oral #LB-152 Mean HCV RNA, log 1 IU/mL ± SD 6.7 ±.6 Median CD4 cell count, cells/µl (range) 628 (16-269) HIV ART, n (%) Efavirenz + FTC + TDF 16 (48) Raltegravir + FTC + TDF 146 (44) Rilpivirine + FTC + TDF 29 (9) FTC, emtricitabine; TDF, tenofovir disoproxil fumarate SVR12: Overall, TN vs TE and by Cirrhosis Status 1 8 Overall 9 6 Naïve vs Experienced Cirrhosis Status SVR12 (%) LDV/SOF 12 Weeks 2 Naïv e Experienced 2 321/ /15 179/ /268 63/67 No Cirrhosis Cirrhos is Among those who were treatment-experienced with cirrhosis, 98% (46/47) achieved an SVR12 Naggie et al, CROI 215, Oral #LB-152 Page 9 of 15

10 ION-4: LDV/SOF in HIV/HCV for 12 weeks SVR12 by Subgroup SVR12 (%) 96% 96% 95% 1% 96% 96% 96% 1% 99% 9% 321/ /276 56/59 36/36 285/ /25 74/77 8/8 215/217 13/115 Overall Male Female BL HCV BL HCV GT 1a GT 1b GT 4 Non-black Black RNA RNA <8K 8K Statistically significant in multivariate analysis All relapsers in the Black cohort had cirrhosis Naggie et al, CROI 215, Oral #LB-152 ALLY-2 Study: SVR12 Rates for Daclatasvir + Sofosbuvir for 8 or 12 weeks in HIV/HCV Coinfection SVR12 (%) Week Regimen HCV treatmentnaïve 97% 98% 76% Relapse Relapse Relapse (n=1) (n=1) (n=1) Overall (n=11/52/5) 12-Week Regimen 76% HCV treatment-naïve HCV treatment-experienced 96% 98% 1% Genotype 1 (n=83/44/41) 83% Genotype 2 (n=11/2/6) 1% 1% 67% 1% Genotype 3 (n=6/4/3) 12-week regimen: no impact of race, baseline HCV RNA, cirrhosis, baseline NS5A RAVs, or ART regimens on SVR12. Genotype 4 results not shown (n=3). Wyles D. et al. NEJM 215. Page 1 of 15

11 C-EDGE: SVR12 Rates With Grazoprevir/Elbasvir in HCV Patients With HIV Coinfection % 93.1% 93.2% 1% 92.9% 94% SVR12 (%) Overall (n=218) 1a (n=144) 1b (n=44) Genotype 4 (n=28) Yes No (n=35) (n=183) Baseline Cirrhosis SVR12 by ART containing: abacavir (95.7%), tenofovir DF (97.5%), raltegravir (96.4%), dolutegravir (1%), rilpivirine (94.6%). Rockstroh JK, et al. J Hepatol. 215;62(suppl 2):S675. Abstract P887. ASTRAL-5 HIV/HCV Coinfection Study 12 weeks of Sofosbuvir/Velpatasvir SVR12 (%) relapse 1 LTFU 62 1 LTFU Total 1a 1b Genotype 11 1 withdrew consent 11 4 LTFU, lost to follow-up. Error bars represent 95% confidence intervals. 22 Page 11 of 15

12 HIV/HCV: Compensated Cirrhosis Regimen Genotype Weeks Study SVR12 Velpatasvir + Sofosbuvir all 12 ASTRAL-1 19/19 (1%) Sofosbuvir + ledipasvir 1 12 ION 4 63/67 (94%) Elbasvir/grazoprevir 1,4 12 C-Edge coinfection 35/35 (1%) Paritaprevir/Ombitasvir/RBV 1 12 Turquoise-1 5/6 (83%) Daclatasvir + Sofosbuvir /RBV ALLY-2 39/4 (98%) NOT HEAD TO HEAD TRIALS Guidelines from EASL and AASLD/IDSA: Prioritize HCV Treatment for Persons with HIV Coinfection Recommendation HIV/HCV-coinfected persons should be treated and retreated the same as persons without HIV infection, after recognizing and managing interactions with antiretroviral medications Rating: Class I, Level B Treatment should be prioritized in patients at high risk for liver-related complications which includes patients with HCV/HIV coinfection, regardless of fibrosis stage Treating patients at high risk for transmitting HCV to others may decrease transmission and HCV disease prevalence which includes MSM with high-risk sexual practices and active injection drug users AASLD/IDSA/IAS USA. Recommendations for testing, managing, and treating hepatitis C Page 12 of 15

13 Acute HCV: Ledipasvir/Sofosbuvir for 6 weeks in Treatment of acute HCV in HIV coinfection 26 HIV patients with acute HCV GT 1 or 4 HCV Ab/PCR negative in previous 6 months Week 6 18 N=26 LDV/SOF FDC LDV/SOF N=26 Mean age, y (range) 41 (25-58) SVR12 Men, n (%) 26 (1) White, n (%) 24 (92) Mean BMI, kg/m2 (range) 24 (2-35) IL28B CC, n (%) 12 (46) GT, n (%) 1a 18 (69) 4 8 (31) Mean HCV RNA, log1 IU/mL (range) 5.4 (<LLOQ-7.3) Mean CD4 count, cells/ul (range) 675 ( ) Rockstroh J, et al. 23rd CROI; Boston, MA; February 22-25, 216. Abst. 154LB. SVR4 and SVR12 4 Virologic failures* 22/26 SVR4 4 Virologic failures* 2 Lost to followup 2/26 SVR12 GT (LiPA) Baseline HCV RNA, log 1 IU/mL IL28B BMI, kg/m 2 Duration of Infection, weeks CT a 7. CT 22 N/A 1a 7.2 CT Rockstroh, J et al. CROI 216; Boston #154LB 26 *3 patients relapsed, 1 was reinfected (GT 1a at baseline, 4d in post-treatment). Error bars represent 95% confidence intervals. Page 13 of 15

14 Acute HCV LDV/SOF study: Baseline HCV RNA and Treatment Outcome (SVR) 8 SVR12 SVR4 Relapse Reinfection 7 HCV RNA (log 1 IU/mL) Rockstroh J, et al. 23rd CROI; Boston, MA; February 22-25, 216. Abst. 154LB. Individual Patients Incidence of Sexually Transmitted Hepatitis C Virus Infection in HIV-positive Men Who Have Sex with Men: a Systematic Review and Meta-Analysis HCV seroconversion increased from an estimated rate of: 1991:.42/1 person-years to 21: 1.9/1 person-years and 212: 1.34/1 person-years Infections were attributable to high-risk behaviors including traumatic sex and sex while on methamphetamines Hagan H et al. AIDS 215 Page 14 of 15

15 Persons with HIV infection may be a greater risk for HCV re-infection following curative treatment Risk of HCV reinfection following SVR: meta-analysis of 66 studies in 11,71 patients HIV-infected male partners with re-infection with telaprevir resistant HCV (V36M) Franco et al. Gastroenterology 214; Hill et al CROI 215 (#654) HCV Management and treatment: HIV/HCV coinfection Are there clinically important drug-drug interactions? Expert consideration of HIV and HCV disease Treatment should not be shortened to 8 weeks for most HIV coinfected patients Risk of re-infection may be high among HIV-infected MSM Harm-reduction after SVR Page 15 of 15

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