INDUCTION/MAINTENANCE Clinical Case
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1 INDUCTION/MAINTENANCE Clinical Case Dr. Jose R
2 INDUCTION/MAINTENANCE (more or less) Dr. Jose R
3 Disclosures Speaker s Bureau: Viiv, Janssen, Abbvie, BMS, Gilead, MSD Board Member/Advisory Panel: Merck, Gilead Induction-maintenance 3
4 Past Medical History Syphillis in 1976 Oral candidiasis in Oct 1994 Surgery for gastric perforation 1998 Recurrent genital herpes Prior smoker 1995 Induction-maintenance 4
5 Past Medical History HIV diagnosed in Oct Heterosexual. 40 years old No hepatitis coinfections Induction-maintenance 5
6 PRIOR ART June 1996: AZT-DDI. CD4 328 May 1997: AZT-DDC Induction-maintenance 6
7 INDUCTION-MAINTENANCE June 1996: AZT-DDI May 1997: AZT-DDC Resitance testing 10/2004 while still receiving AZT-ddC Genotype showing? Induction-maintenance 7
8 QUESTION (AZT-DDI, AZT-DDC) 1. M41L, D67N, K70R, T215F, K219Q 2. K65R, L210W Induction-maintenance 8
9 QUESTION Induction-maintenance 9
10 INDUCTION-MAINTENANCE June 1996: AZT-DDI May 1997: AZT-DDC Resitance testing 10/2004 while still receiving AZT-ddC M41L, D67N, K70R, T215F, K219Q Induction-maintenance 10
11 INDUCTION-MAINTENANCE Induction-maintenance 11
12 INDUCTION-MAINTENANCE June 1996: AZT-DDI May 1997: AZT-DDC Resitance testing 10/2004 while still receiving AZT-ddC: M41L, D67N, K70R, T215F, K219Q May 2005 with 756 CD4 and VL of 38,000 treatment switched to... Induction-maintenance 12
13 QUESTION. MAY 2005 (756 CD4 and VL of 38,000, M41L, D67N, K70R, T215F, K219Q ) 1. Treatment interruption 2. TDF monotherapy to mantain decreased fitness 3. LPV/r + FTC + T LPV/r + FTC + EFV 5. TDF/FTC + ATV/r MORE DRUGS LESS DRUGS TDF Induction-maintenance 13
14 INDUCTION-MAINTENANCE June 1996: AZT-DDI May 1997: AZT-DDC Resitance testing 10/2004 while still receiving AZT-ddC: M41L, D67N, K70R, T215F, K219Q May 2005 with 756 CD4 and VL of 38,000 treatment switched to... TDF monotherapy Induction-maintenance 14
15 IMPACT ON FITNESS (M41L, D67N, K70R, T215F, K219Q) Induction-maintenance 15
16 IMPACT ON FITNESS (M41L, D67N, K70R, T215F, K219Q) Deeks NEJM Induction-maintenance 16
17 INDUCTION-MAINTENANCE Remains on TDF monotherapy from May/2005 until March/2009 when he reached 360 CD4 and a viral load of New genotype showing 1. M41L, D67N, T69N; K70R, T215F, K219Q Induction-maintenance 17
18 INDUCTION-MAINTENANCE Induction-maintenance 18
19 INDUCTION-MAINTENANCE Remains on TDF monotherapy from May/2005 until March 2009 when he reached 360 CD4 and a viral load of 8,000 New genotype showing? M41L, D67N, T69N; K70R, T215F, K219Q Patient switched to... (INDUCTION REGIMEN) Induction-maintenance 19
20 QUESTION (360 CD4 and a viral load of 8,000, TDF monotherapy M41L, D67N, T69N; K70R, T215F, K219Q) 1. TDF/FTC-ATV/r 2. FTC-ATV/r-RAL 3. FTC-DRV/r-ETV 4. FTC-LPV/r-RAL LESS DRUGS MORE DRUGS Induction-maintenance 20
21 QUESTION (360 CD4 and a viral load of 8,000, TDF monotherapy M41L, D67N, T69N; K70R, T215F, K219Q) M41L, D67N, T69N; K70R, T215F, K219Q Patient switched to... TDF/FTC-ATV/r Induction-maintenance 21
![GARDEL Viral load <50 copies/ml at weeks 48 and 96 (ITTe) Patients with HIV-1 RNA <50 copies/ml (%) 100% 90% 80% 70% 60% 50% 40% 30% Week 48 (P=0.171, difference +4.6% [95% CI: 2.2%, +11.8%]) 88.](/docs-images/89/97703213/images/22-2.jpg "3% 90.3% 83.7% 84.4% Week 96 (P=0.165, difference +5.91% [95% CI: 2.3%, 14.1%]) 20% 10% DT TT 0% 0 BSL W4 4 W8 8 W12 W24 W36 W48 W96 Time (weeks) Cahn P et al. EACS 2015.")
22 GARDEL Viral load <50 copies/ml at weeks 48 and 96 (ITTe) Patients with HIV-1 RNA <50 copies/ml (%) 100% 90% 80% 70% 60% 50% 40% 30% Week 48 (P=0.171, difference +4.6% [95% CI: 2.2%, +11.8%]) 88.3% 90.3% 83.7% 84.4% Week 96 (P=0.165, difference +5.91% [95% CI: 2.3%, 14.1%]) 20% 10% DT TT 0% 0 BSL W4 4 W8 8 W12 W24 W36 W48 W96 Time (weeks) Cahn P et al. EACS Abstract PS10/4 Induction-maintenance 22
23 INDUCTION-MAINTENANCE M41L, D67N, T69N; K70R, T215F, K219Q Patient switched to... TDF/FTC-ATV/r Doing well on TDF/FTC-ATV/r from March/2009 to September/2009 (CD4 558, VL < 50) In September/2009 another doctor sees the patient and ask why this patient is on TDF if genotype confers high-level resistance? (CD4 558, VL < 50) Induction-maintenance 23
24 QUESTION 1) New doctor doesn t even think to change a regimen prescribed by Dr. Arribas 2) New doctor couldn t care less and changes regimen. Induction-maintenance 24
25 INDUCTION-MAINTENANCE Regimen switched to FTC-ATV/r Induction-maintenance 25
26 SALT STUDY Perez-Molina, Journal of Antimicrobial Chemotherapy, dkw Induction-maintenance 26
27 SALT STUDY Perez-Molina, Journal of Antimicrobial Chemotherapy, dkw Induction-maintenance 27
28 INDUCTION-MAINTENANCE Regimen switched to FTC-ATV/r Patient keeps doing well for 5 years on FTC- ATV/r On 11/2014 (CD4 932, VL < 50) starts treatment with omeprazol Regimen switched to... Induction-maintenance 28
29 QUESTION (CD4 932, VL < 50M, OMEPRAZOL, FTC-ATV/r) 1. FTC-LPV/r 2. FTC-DRV/r Induction-maintenance 29
30 OLE HIV-1 RNA <50 copies/ml On triple therapy with for at LPV/r + 2 nucleosides* for at least 6 months No resistance to LPV/r or 3TC/FTC No positive HBsAg Randomization 1:1 LPV/r BID + 3TC QD (DT, dual therapy) LPV/r BID + 2 NUCS (TT, triple therapy) 0 48 weeks *ABC/3TC, TDF/FTC, TDF/3TC Primary endpoint Arribas JR et al. Lancet Infect Dis 2015;15: Induction-maintenance 30
31 OLE Dual therapy Triple therapy 97,29 97,34 89,83 90, Virologic failure Blips Virologic failure or any blip Arribas JR et al. Lancet Infect Dis 2015;15: Induction-maintenance 31
32 Non-inferiority of dual-therapy with darunavir/ritonavir plus 3TC vs. triple therapy with darunavir/ritonavir plus TDF/FTC or ABC/3TC for maintenance of viral suppression: 48-week results of the DUAL-GESIDA 8014-RIS-EST45 Trial DUAL: DarUnavir And Lamivudine Federico Pulido. Esteban Ribera. María Lagarde. Ignacio Pérez-Valero. Jesús Santos. José A. Iribarren. Antonio Payeras. Pere Domingo. José Sanz. Miguel Cervero. Adrián Curran. Francisco J. Rodríguez. María J. Téllez. Pablo Ryan. Pilar Barrufet. Hernando Knobel. Antonio Rivero. Belén Alejos. María Yllescas. José R. Arribas. DUAL-GESIDA-8014-RIS-EST45 Study Group Abstract #: O331
33 QUESTION 1. FTC-LPV/r 2. FTC-DRV/r Induction-maintenance 33
34 INDUCTION-MAINTENANCE M41L, D67N, T69N; K70R, T215F, K219Q Regimen switched to FTC-ATV/r Patient keeps doing well on FTC-ATV/r On 11/2014 (CD4 932, VL < 50) starts treatment with omeprazol Regimen switched to.. FTC-DRV/r Induction-maintenance 34
35 INDUCTION-MAINTENANCE M41L, D67N, T69N; K70R, T215F, K219Q Patient keeps doing well on FTC-ATV/r On 11/2014 (CD4 932, VL < 50) starts treatment with omeprazol Regimen switched to.. FTC-DRV/r Patient doing well until August/2015 (CD4 1029, VL <50) Induction-maintenance 35
36 INDUCTION-MAINTENANCE Patient doing well until August/2015 (CD4 1029, VL <50) Angina. Cath with severe artheriosclerotic disease of 3 main vessels. 3 stents Depressive/ansious syndrome. On follow-up by Psychiatry Chronic low back pain Bisoprolol, Nigroglicerin patch, Aspirin, Trazodone, Clonazepam, Gabapentine, Atorvastatin LDL 65, HDL 40 Induction-maintenance 36
37 INDUCTION-MAINTENANCE 8/2015. Severe cardiovascular disease. Chronic pain. Polypharmacy. Regimen switched to... Induction-maintenance 37
38 QUESTION (M41L, D67N, T69N; K70R, T215F, K219Q. On DRVr + FTC) 1. DTG-RPV 2. FTC-DTG 3. TDF/FTC-DTG 4. FTC-DTG-RPV LESS DRUGS MORE DRUGS Induction-maintenance 38
39 SWORD STUDIES Induction-maintenance 39
40 INDUCTION-MAINTENANCE 8/2015. Severe cardiovascular disease. Chronic pain. Polypharmacy. Regimen switched to... TDF/FTC-DTG Induction-maintenance 40
41 QUESTION Would it work (TDF/FTC-DTG)? 1. Yes 2. No Induction-maintenance 41
42 QUESTION Would it work better (TAF/FTC-DTG)? 1. Yes 2. No VIROLOGIST IN THE ROOM Induction-maintenance 42
43 QUESTION Would it work better (TAF/FTC-DTG)? Induction-maintenance 43
44 INDUCTION-MAINTENANCE August/2015. Severe cardiovascular disease. Chronic pain. Polypharmacy. Regimen switched to... TVD-DTG October/2016. VL < 50. CD4 720 Induction-maintenance 44
45 INDUCTION-MAINTENANCE August/2015. Severe cardiovascular disease. Chronic pain. Polypharmacy. Regimen switched to... TVD-DTG October/2016. VL < 50. CD4 720 Induction-maintenance 45
46 PADDLE Study: Efficacy # SCR BSL DAY 4 DAY 7 W.2 W.3 W.4 W.6 W.8 W.12 W.24 W.36 W <50 <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 <50 < Not done 105 <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 SAE <50 <50 <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 < <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 < < <50 <50 <50 <50 <50 < <50 <50 <50 Not done <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 <50 <50 < <50 <50 <50 <50 <50 PDVF <50 <50 <50 <50 <50 <50 <50 <50 <50 SAE = serious adverse event PDVF = protocol defined virologic failure Cahn P, et al. AIDS 2016; Durban, South Africa; July 18-22, 2016; Abst. FARB0104LB.
47 GEMINI STUDIES Induction-maintenance 47
48 QUESTION Would you switch to FTC-DTG? 1. Yes 2. No Induction-maintenance 48
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Dr. Jose R Arribas @jrarribas Financial disclosures JOSE R ARRIBAS Research Support: Speaker s Bureau: Viiv, Janssen, Abbvie, BMS, Gilead, MSD Board Member/Advisory Panel: Merck, Gilead Stock/Shareholder:
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