TAF an overview Who? When? How? co-infected/ monoinfected

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1 TAF an overview Who? When? How? co-infected/ monoinfected Dr Kosh Agarwal Institute of Liver Studies King s College Hospital ICVH Chicago 2017

2 Disclosures I am a Hepatologist Involved in the global TAF program EASL panel Abbvie, Astellas, Achillion, BMS, Gilead, Merck, Intercept, Vir Acknowledge R Byrne

3 Prodrug Pharmacology Tenofovir alafenamide (TAF) A Novel Prodrug of Tenofovir GI TRACT TFV (tenofovir) RENAL TUBULAR CELL TFV OAT OAT 1 1& &3 3 PLASMA HEPATOCYTE DIANION TFV TDF (tenofovir disoproxil fumarate) ESTER 300 mg short plasma half-life TFV TAF (tenofovir alafenamide) 25 mg TFV-DP longer plasma half-life - greater plasma stability ~90% LOWER PLASMA TFV AMIDATE RENAL TUBULAR CELL OAT OAT 1&3 TFV T1/2 based on in vitro plasma data - TDF = 0.4 minutes, TAF = minutes. Lee W et. Antimicr Agents Chemo 2005;49(5): Birkus G et al. Antimicr Agents Chemo 2007;51(2): Babusis D, et al. Mol Pharm 2013;10(2): Ruane et al. J Acquir Immune Defic Syndr 2013; 63: Sax P, et al. JAIDSDRAFT FOR Sep 1;67(1):52-8. Sax P,USE et al. Lancet 2015.NOT Jun 27;385(9987): Agarwal KOR et al.promotion. J Hepatology 2015; 62: ; 3 -P,GILEAD CONFIDENTIAL AND PROPRIETARY INTERNAL ONLY. FOR DISTRIBUTION Buti M et al. Lancet G&H 2016; doi: /S (16) ; Chan HLY et al. Lancet G&H 2016; doi: / /S (16) HBV

4 Older patients: risk of co-morbidities in European real-world cohorts VIREAL cohort (n=440)1 Mean age 45 years (11% 65 years) Treatment experienced: 59% Patients (%) Marcellin P, et al. Dig Dis Sci 2016;61: ; 2. Petersen J, et al. Dig Dis Sci 2016;61: GEMINIS cohort (n=400)2 Mean age 45 years (9% 65 years) Treatment experienced: 54% Consider DDIs if 2.3 using 2.1polypharmacy to manage co-morbidities DDI: drug drug interaction

5 Many factors affect CHB disease progression Multiple factors affect CHB disease progression Patient Fattovich G. Semin Liver Dis 2003;23:47 58, Fattovich G, et al. J Hepatol 2008;48:335 52

6 Gill, Zissimopoulos et al., J. Infect Dis. 2014

7 Study 108 and 110: Phase 3 CHB Studies: TAF vs TDF Submitted to J Hep

8 Study 108 and 110: Phase 3 CHB Studies: TAF vs TDF P ro p o rtio n o f P a tie n ts, % ( 9 5 % C I) Antiviral Efficacy of TAF and TDF at Week 48 Rates of Viral Suppression HBV DNA <29 IU/mL HBeAg- HBeAg+ TAF: 94% TDF: 93% TAF TDF 80 TAF: 64% TDF: 67% Treatment difference +1.8 (-3.6, +7.2); p= Treatment difference: 3.6 ( 9.8, 2.6); p= Week Week HBV DNA suppression rates were lower in HBeAg+ vs HBeAg patients No significant difference between TAF and TDF No resistance was detected through 48 weeks Seto, AASLD 2016, Oral 67 HBV DNA suppression was comparable between TAF and TDF treatment up to Week 72

9 Study 108 and 110: Phase 3 CHB Studies: TAF vs TDF P a t ie n t s W it h A L T N o r m a liz a t io n, % ALT Normalisation of TAF and TDF at Week 72 AASLD Criteria P a t ie n t s W it h A L T N o r m a liz a t io n, % 40 * TAF TDF TAF: 49.1% TDF: 39.0% * Central Lab Criteria * * * * * 100 * TAF: 76.1% TDF: 68.4% * Significantly higher ALT normalisation rate with TAF vs TDF <19 and <30 U/L for females and males, respectively 34 and 43 U/L for females and males, respectively, aged <69 y, and 32 and 35 U/L, respectively, aged >69 y Fung, AASLD 2016, Poster 1852; Data on File, Gilead Sciences Inc. *p<0.05 p<0.005 p 0.001

10 Study 108 and 110: Phase 3 CHB Studies: TAF vs TDF Renal Laboratory Parameters in CHB Patients Treated with TAF or TDF M e d ia n e G F R C h a n g e, % M e d ia n e G F R C h a n g e, % Smaller egfr declines with TAF vs TDF in patients with older age and those with comorbid conditions (HTN/DM/CVD) Age n=642 0 n=294 Age <50 y n=185 n=123 Age 50 y Comorbid Conditions n=691 0 n=136 No HTN/DM/CVD n=80 HTN/DM/CVD P< n= P=0.01 n=5 P<0.001 n=8 P=0.003 n=5 n=8 In patients at greater risk for kidney disease, TAF treatment resulted in smaller declines in egfrcg and fewer patients showed CKD stage worsening compared with TDF treatment *p-values from Wilcoxon 2-sample test; Hypertension (HTN), diabetes mellitus (DM), and cardiovascular disease (CVD) determined by medical history or concomitant medication. Agarwal, AASLD 2016, Poster 1844

11 TAF Phase 3: Week 96 Results TAF Group Performance Relative to TDF Group Week 48 Week 96 Viral Suppression Non-inferior Non-inferior ALT Normalization Significantly Better Significantly Better Bone Safety Significantly Better Significantly Better* Renal Safety Significantly Better Significantly Better* None None Viral Resistance early biomarkers clinical endpoints

12 Management of HIV co-infected patients Recommendations: 1) All HIV-positive patients with HBV co-infection should start antiretroviral therapy (ART) irrespective of CD4 cell count. (Evidence level II-2, grade of recommendation 1) 2) HIV-HBV co-infected patients should be treated with a TDF- or TAF-based ART regimen. (Evidence level I for TDF, II-1 for TAF, grade of recommendation 1) EASL 2017 CPG HBV, J Hepatol 2017

13 NA for naïve CHB patients Recommendations: 1) The long-term administration of a potent NA with high barrier to resistance is the treatment of choice regardless of the severity of liver disease. (Evidence level I, grade of recommendation 1) 2) The preferred regimens are ETV, TDF and TAF as monotherapies. (Evidence level I, grade of recommendation 1) 3) LAM, ADV and TBV are not recommended in the treatment of CHB. (Evidence level I, grade of recommendation 1) EASL 2017 CPG HBV, J Hepatol 2017

14 Indications for selecting ETV or TAF over TDF* * TAF should be preferred to ETV in patients with previous exposure to nucleoside analogues. ** ETV dose needs to be adjusted if egfr <50 ml/min; no dose adjustment of TAF is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) 15 ml/min or in patients with CrCl <15 ml/min who are receiving haemodialysis. EASL 2017 CPG HBV, J Hepatol 2017

15 HIV Survival Efficacy Tolerability

16 Background Tenofovir disoproxil fumarate (TDF) is included in most recommended antiretroviral regimens, and although potent and generally well tolerated, has been associated with clinically significant renal and bone toxicity1-3 Relative to TDF 300 mg, tenofovir alafenamide (TAF) 25 mg has 90% lower circulating plasma TFV, while maintaining high antiviral activity4 1. DeJesus E, et al. Lancet 2012;379: ; 2. Gallant JE, et al. J Infect Dis 2013;208:32-9; 3. Sax PE, et al. Lancet 2012;379: ; 4. Ruane P, et al. J Acquir Immune Defic Syndr 2013; 63:

17 FDA TAF Timeline Elvitegravir/cobicistat/emtricitabine/TAF - Genvoya; approved November 2015 Emtricitabine/rilpivirine/TAF - Odefsey; approved March 2016 Emtricitabine/TAF - Descovy; approved April 2016 TAF (compensated HBV) - Vemlidy; approved November 2016

18 TAF as initial HIV Therapy: Studies 104 and 111 Primary Endpoint Week 0 n=866 Tx-Naïve Adults HIV-1 RNA 1000 c/ml egfr 50 ml/min E/C/F/TAF QD 1:1 n=867 E/C/F/TDF QD (Stribild, STB) Two Phase 3 randomized, double-blind, double-dummy, active-controlled studies Study 104 (North America, EU, Asia), Study 111 (North America, EU, Latin America) Stratified by HIV-1 RNA, CD4 cell count, geographic region Primary endpoint: proportion of patients with HIV-1 RNA <50 copies/ml (Taqman 2.0) Non-inferiority (12% margin) based on Week 48 FDA snapshot analysis Combined efficacy analysis pre-specified Pre-specified Week 48 safety endpoints: serum creatinine, proteinuria, hip BMD, spine BMD 18

19 Primary Endpoint: HIV-1 RNA <50 copies/ml at Week 48 Studies 104 and 111: Week 48 Combined Analysis Treatment Difference (95% CI) HIV-1 RNA <50 c/ml, % Virologic Outcome 100 E/C/F/TAF (n=866) E/C/F/TDF (n=867) Favors E/C/F/TDF Favors E/C/F/TAF % 0.7% 4.7% Success 4 Failure 4 6 No Data 12% 0 +12% E/C/F/TAF was non-inferior to E/C/F/TDF at Week 48 in each study 93% E/C/F/TAF vs 92% E/C/F/TDF (Study 104) 92% E/C/F/TAF vs 89% E/C/F/TDF (Study 111) 19

20 TAF vs. TDF Summary Virologic efficacy: E/C/F/TAF noninferior to E/C/F/TDF1 TAF associated with: Smaller decrease in egfr (-6.4 vs. -11 ml/min) Less proteinuria Smaller decrease in bone mineral density (BMD) But greater increase in cholesterol, LDL, HDL, TGs D TC: +29 mg/dl D LDL: + 14 mg/dl D TC:HDL: same HIV-1 RNA <50 % E/C/F/TAF 80 E/C/F/TDF Success 4 Failure 4 6 No Data EVG/c/FTC/TAF approved for patients with CrCL down to 302 Sax P et al, Lancet, 2015; 2Pozniak A et al, JAIDS,

21 Conclusions Studies 104 and 111: Week 48 Combined Analysis 92% of patients treated with E/C/F/TAF achieved virologic suppression through Week 48 (combined analysis) Virologic response for E/C/F/TAF, 93% (Study 104) and 92% (Study 111) E/C/F/TAF was non-inferior to E/C/F/TDF High and similar response rates, irrespective of age, sex, race, HIV-1 RNA, and CD4 cell count Low rates of virologic failure, with resistance <1% in both arms Both drugs were well tolerated and safe Discontinuations due to AEs were low in both arms 0.9% (8) for E/C/F/TAF vs 1.5% (13) for E/C/F/TDF No proximal tubulopathy cases Common AEs similar between treatment arms 21

22 GS-US single-arm, open-label Phase 3 study of HIV-1-infected participants with mild-moderate renal impairment (egfrcg ml/min) who switched to E/C/F/TAF Primary Endpoint Week N= E/C/F/TAF QD Phase 3, 96-week, multicenter, open-label study of virologically suppressed adults switching from TDF- or non-tdf containing regimens to E/C/F/TAF Eligibility: stable egfrcg (30 69 ml/min) Primary endpoint: change from baseline in egfr at Week 24 Actual GFR assessed with iohexol clearance in a participant subset A Pozinak J Acquir immun Def Syn 2016

23 Proteinuria: Change From Baseline to Week 48 Total* TDF* Non-TDF Baseline 200 Week Median (µg/g) Median (mg/g) UPCR 10 UACR RBP:Cr b-2-m:cr Tubular Proteins *All Total and TDF changes statistically significant; all non-tdf changes not statistically significant. 23

24 BMD: Mean Change from Baseline to Week 48 TDF Total Non-TDF Hip 2.95* 2.29* 0.99 Mean (SD) % Δ Hip BMD Mean (SD) % Δ Spine BMD Spine 1.85* 1.47* 0.70 Baseline Week 24 Week 48 Baseline Week 24 Week 48 n=236 n=226 n=214 n=236 n=225 n=216 *p<0.05 by two-sided Wilcoxon signed-rank test. 24

25 Conclusions Participants on TDF at time of switch had No change in actual GFR Significant improvements in urinary markers of renal function Significant improvements in BMD Significant increases in lipids Participants not on TDF at time of switch had No changes in actual GFR Stable urinary markers of renal function and BMD Significant decreases in cholesterol fractions 25

26 HIV/HBV co-infection data Limited GS US open-label, small sample, noncomparative switch study evaluating the efficacy and safety of E/C/F/TAF in HIV suppressed, HBV co-infected participants At 48 weeks, 91.7% of the 72 participants maintained or achieved virologic suppression (HIV-1 RNA <50 copies/ml; HBV DNA <29 IU/mL) Gallant J Acquir immun Def Syn 2016

27 GS US Participants maintained high rates of HIV and HBV suppression, had improved renal function, and reduced biomarkers of bone turnover, consistent with other E/C/F/TAF studies E/C/F/TAF was well tolerated with no discontinuations because of renal events Seroconversion occurred in 2.9% of HBsAg-positive participants and 3.3% of HBeAg-positive participants 40% of those with abnormal ALT normalized by week 48; which is lower than the percentage seen in naive HBV-monoinfected populations and similar to treatment-experienced coinfected populations There were no ALT flares, and assessments of other liver-related parameters did not suggest increased hepatic risk. E/C/F/TAF was effective against HIV and HBV, well tolerated, and demonstrated improvements in renal and bone safety consistent with the clinical profile of TAF.

28 Management of HIV co-infected patients Recommendations: 1) All HIV-positive patients with HBV co-infection should start antiretroviral therapy (ART) irrespective of CD4 cell count. (Evidence level II-2, grade of recommendation 1) 2) HIV-HBV co-infected patients should be treated with a TDF- or TAF-based ART regimen. (Evidence level I for TDF, II-1 for TAF, grade of recommendation 1) EASL 2017 CPG HBV, J Hepatol 2017

29 TAF or TDF When should you definitely use TAF over TDF? Patient with osteoporosis or osteopenia Patient with renal disease (egfr >30) or evidence for proximal tubular dysfunction (e.g. proteinuria) Growing proportion of patients: greying of the epidemic When should you definitely not use TAF? Patient on rifamycin (may decrease TAF levels) Pregnant women For pre-exposure prophylaxis (PrEP)??

30 Should TAF replace TDF? Reasons to choose TAF Reasons to choose TDF TAF is virologically as effective as TDF. Compared with TDF, TAF has more favorable effects on renal and bone markers. Particularly important in patients who already have renal or bone disease or who are at high risk of these complications. Compared with TAF, more and longer-term data with TDF, particularly in studies in treatment naïve patients. More favorable lipid effects. Renal and bone marker advantages of TAF not yet known to translate into better clinical outcomes. TDF-regimens likely to be cheaper than TAF when TDF goes generic. Cost of TAF- and TDF-regimens currently similar

31 Issues? Cost and access NAFLD/Lipids Cost/generic TDF Long term data Short term data -?significant clinical outcomes

32

33 KOSH FYI current NHSE policy for TAF in HIV NHSE have approved funding of TAF for the following categories of patients: 1. Patients with definite contra-indication or intolerance to tenofovir disoproxil fumarate (TDF) and abacavir. Confirmed osteoporosis on DEXA or a high risk of major fracture as determined by FRAX Renal disease based on NICE definition CKD stage G3 or stage G1/2 plus stage A3 proteinurea Previous renal toxicity or intolerance of TDF 2.Patients with relative contra-indication or intolerance to TDF and abacavir Approaching threshold of osteoporosis Renal markers approaching thresholds where TAF is thought to be more appropriate VC referral?? Category 1 Virtual clinic referral NOT required Patients with a definite contra-indication or intolerance to tenofovir disoproxil and abacavir Confirmed osteoporosis on DEXA or a high risk of major fracture as determined by FRAX (FRAX score >10%) Renal disease based on NICE definition CKD stage G3 (egfr < 60ml/min) or stage G1/2 plus stage A3 proteinurea (egfr >60ml/min plus severe proteinurea). Switch to TAF should generally be based on more than an isolated reading for renal disease. Previous renal toxicity or intolerance of TDF Patients starting or switching to TAF who fall in category 1 do not require referral and approval by the virtual clinic. The reason for the choice of TAF as opposed to tenofovir disoproxil or abacavir must be clearly documented in the notes by the prescriber, for future audit purposes. Category 2 virtual clinic referral required Patients with relative contra-indication or intolerance to TDF and where abacavir is not a suitable alternative Where there is an increased risk of bone disease and fracture probability: children and young people below age of peak bone mass (approx. 25 years), post-menopausal women, those on long-term glucocorticoid therapy or those who have already had a low-trauma fracture or who fall frequently. Renal disease based on NICE definition CKD G1 or 2 plus A2 proteinurea (egfr> 60mls/min and moderate proteinurea) and one of the following additional risk factors: older age, diabetes, cardiovascular disease and hypertension. Other co-morbidities and concomitant nephrotoxic medication should be considered if associated with a higher risk of chronic renal disease progression. Patients who are starting or switching to TAF under category 2 must be referred to the virtual clinic for approval. Ideally this should be done prospectively. If TAF is required urgently then this must be discussed with agreed with a consultant physician and a retrospective referral made to the virtual clinic. The reason for the choice of TAF as opposed to tenofovir disoproxil or abacavir must be clearly documented in the notes by the prescriber, for future audit purposes.

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