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Michael S. Saag, MD Professor of Medicine Associate Dean for Global Health University of Alabama at Birmingham Birmingham, Alabama Cases From the Clinic(ians):

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Presentation on theme: "Michael S. Saag, MD Professor of Medicine Associate Dean for Global Health University of Alabama at Birmingham Birmingham, Alabama Cases From the Clinic(ians):"— Presentation transcript:

1 Michael S. Saag, MD Professor of Medicine Associate Dean for Global Health University of Alabama at Birmingham Birmingham, Alabama Cases From the Clinic(ians): A Case-based, Panel Discussion FORMATTED: 03-28-16 Chicago, Illinois: May 9, 2016 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA.

2 Slide 2 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Learning Objectives After attending this presentation, participants will be able to: Select antiretroviral therapy for patients who are: – Coinfected with hepatitis B virus and HIV – Pregnant – Partners of HIV-seropositive patients – Experiencing chronic kidney disease

3 Slide 3 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Cost Effectiveness of 5 ARVs (‘07-’12) FTC/RPV/TDF EFV/FTC/TDF

4 Slide 4 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Minimum Costs of ARV treatments ______________________________________________________________ CombinationEstimated price / year ______________________________________________________________ TDF/3TC/ATV/r$279 TDF/FTC/ELV/c$184 ABC/3TC/DTG$179 TDF/FTC/EFV600$144 TDF/3TC/EFV600$130 TDF/3TC/EFV400$100 TAF/3TC/DTG$60 DTG/3TC$46 _______________________________________________________ GREEN – FULLY GENERIC WORLDWIDE IN 2017 RED – STILL PATENTED TO 2025+ : VOLUNTARY LICENSES

5 Slide 5 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Dolutegravir in pregnancy: Background No fetal toxicity or teratogenicity in animal studies described in manufacturer’s submission for regulatory approval 1 High placental transfer of DTG relative to other ARVs in an ex vivo study 2 “Unexpected placental transfer of DTG with fetal accumulation and then slow neonatal clearance” 3 1. European Medicines Agency. Dolutegravir. Annex I: Summary of Product Characteristics. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_- _Product_Information/human/002753/WC500160680.pdf 2. Schalkwijk S, Greupink R, Colbers AP, Wouterse AC, Verweij VGM, van Drongelen J, et al. Placental transfer of the HIV integrase inhibitor dolutegravir in an ex vivo human cotyledon perfusion model. J Antimicrob Chemother. 2015 Nov 3 pii: dkv358. [Epub ahead of print] Available from: http://www.jac.oxfordjournals.org/lookup/doi/10.1093/jac/dkv358http://www.jac.oxfordjournals.org/lookup/doi/10.1093/jac/dkv358 3. Pain JB, Lê MP, Caseris M, Amiel C, Lassel L, Charpentier C, et al. Pharmacokinetics of Dolutegravir in a Premature Neonate after HIV Treatment Intensification during Pregnancy: FIG 1. Antimicrob Agents Chemother [Internet]. 2015 Jun;59(6):3660–2. Available from: http://aac.asm.org/lookup/doi/10.1128/AAC.00173-15

6 Slide 6 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Dolutegravir PK IMPAACT P1026s Mulligan N et al. CROI 2016. Poster abstract 398 DTG AUC 25-30% lower in 2 nd /3 rd trimester vs paired postpartum (PP) data. Differences not significant. DTG Cmax significantly lower in 3 rd trimester vs postpartum. C 24 41% lower in 2 nd /3 rd trimester – not significant. 6/9 (67%) women in 2 nd trimester, 12/15 (80%) in 3 rd and 8/9 postpartum had AUC above 10 th percentile (37.5 mcg*hr/mL) of non- pregnant adults. “ AUC and trough exposures appeared to be lower in pregnancy compared to postpartum. But antepartum AUC and trough values still similar to those seen in non-pregnant adults.”

7 Slide 7 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Hunt, et al. CROI 2016 Abs 671

8 Slide 8 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA.

9 Slide 9 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA.

10 Slide 10 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Change in eGFR (Cockcroft-Gault) with TAF vs TDF Studies 104 and 111: Week 48 Combined Analysis *Cockcroft-Gault (mL/min). -6.6 -11.2 p <0.001 Time (Weeks) Mean (SD) Change from Baseline eGFR*

11 Slide 11 of 11 From MS Saag, MD, at Chicago, IL: May 9, 2016, IAS-USA. Conclusions: Early ART does not seem to be associated with higher mortality in resource rich settings, in contrast to data from resource limited settings Underpowered to provide robust evidence Limitation: lack of data on CM treatment and disease management. We aim to obtain this in the future. Results:  235 patients from 28 cohorts  84% male, median age at CM 38 years.  Death rate at 6 months: 42/235 (18%)  Hazard Ratios (95% CI) for deferred vs early ART  Crude 1.29 (0.68-2.43)  Adjusted 1.30 (0.66-2.55)

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