HIV Care Thailand. Successes vs Challenges. Kiat Ruxrungtham
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1 HIV Care Thailand Successes vs Challenges Kiat Ruxrungtham Professor of Medicine, Chulalongkorn University; and HIV-NAT, Thai Red Cross AIDS Research Center
2 Thailand Translation from Science to Action Sucesses
3
4 When to start ART by guidelines Guidelines CD4 Remark WHO 2016 U.S. DHHS 2016 EACS 2016 Thailand 2016 All All All All When the patient is ready and committed to the life-long treatment
5 Additional year of Life (yrs) 60 Average Life-expectancy National AIDS Program, Thailand ARV started from age 20 Life-expectancy = 72 yo 50 N=12957 Less Equal/more Baseline CD4 counts Remarks: If survived after 6 months, the life-expectancy was increased significantly in all groups Sirinya Teeraananchai et al. Antiviral Therapy 2016
6 Additional year of Life (yrs) Average Life-expectancy 29 National AIDS Program, Thailand Data after survived beyond 6 months of treatment 39 ARV started from age 20 Less 46 Equal/more Baseline CD4 counts 51 Life-expectancy = 81 yo 61 Sirinya Teeraananchai et al. Antiviral Therapy 2016
7 Current and Future direction of HIV Treatment Global and Thailand Status
8 HIV Current Antiretroviral Agents RT Inhibitors (8) NRTI: AZT, ABC,, 3TC,, FTC, TAF NNRTI: EFV, ETV, RPV NTRTI: TDF 1 2 RNA DNA RT vpr ds DNA 3 Transcription Protease Inhibitors (2-3) rtv, LPV/rtv, ATV, DRV Integrase Proviral DNA 4 mrna Genomic RNA 5 6 Protease Entry Inhibitors (1) CCR5 inhbitor: Maraviroc (MVC) Spliced mrna Only N<15 are Currently Prescribing Polyprotein Protein Integrase inhibitors (3) Raltregavir (RAL) Elvitegravir (EVG) Dolutegravir (DTG)
9 Ideal ARVs 1. High Efficacy at any baseline CD4 or VL 2. Excellence tolerability 3. Long-term safety 4. High genetic resistance barrier 5. At least once daily (Long-acting is preferred) 6. No food restriction 7. No drug interaction 8. FDC single tablet regimen with similar half-life 9. Cover both HIV-1, HIV No dose adjustment needed in kidney/liver dis.
10 The Nature of Life Patients older than 50? Careful risk screening is important >20% of old patients are taking 3 other drugs >40% taking lipid lowering agents Smit M, et al. Lancet Infect Dis. 2015;15:
11 Emerging co-morbidities in HIV Renal dysfunction 30% of HIV+ patients have abnormal kidney function 1 Reduced bone mineral density Increased prevalence 63% of HIV+ patients 2 Cancer Neurocognitive dysfunction Impairment present in 50% HIV+ patients 3 Cardiovascular disease 75% increase in risk of acute MI 4 Increased risk of non-aidsdefining cancers e.g. anal, vaginal, liver, lung, melanoma, leukemia, colorectal and renal 5 Gupta SK et al. Clin Infect Dis 2005;40: ,Brown TT et al. J Clin Endocrinol Metab 2004;89(3): , Clifford DB. Top HIV Med 2008;16(2):94 98 Triant VA et al. J Clin Endocrinol Metab 2007;92: , Patel P et al. Ann Intern Med 2008;148:
12 ARV and Risk of Specific Toxicities U.S. DHHS guidelines 2015 TDF Atazanavir/r (renal stone) EVG/cobi 1 DTG 1 TDF Osteoporosis Efavirenz LPV/r ABC* 1 reduced active renal tubular secretion of creatinine with no actual renal impairment. *ABC- CVS risk in some cohorts
13 From TDF to TAF (in 2 in 1 tablet) Less affect on kidney and bones TDF + FTC TAF + FTC The patent on TAF expires until May, 2022 (in next 5 years)
14 Q151M K65R 3 TAMs T69S insertion 4 TAMs 5 TAMs 5 TAMs Margot et al. Gilead Science presented 2013
15 Integrase STIs (INSTIs) Raltegravir 2007 Elvitegravir* 2012 *Stribild : EVG/cobi/TDF/FTC Genvoya: EVG/cobi/TAF/FTC (2015) Vitekta EVG Sep 2014 All are very well tolerated Dolutegravir STR: Triumeq (DTG/ABC/3TC 2013 Aug 2014
16 Dolutegravir : Integrase inhibitor The compound patent for Dolutegravir is expected to expire in 2026 (next 9 yrs)
17 What to start Antiretrovirals NtRTI or NRTI TAF* TDF ABC* *TAF (in FDC) the U.S. DHHS, and EACS guidelines 2016 Combination of the following each ARV from each column NRTI Cytidine Analog FTC + 3TC** Third ARV Dolutegravir Evitegravir/cobi 1 Raltegravir Darunavir/r *if HLA B*5701 is negative, for DTG regimen only **only with ABC/DTG U.S. DHHS Guidelines April 2015; EACS 2015, BHIVA 2015 EACS 2016 also include RPV 1 egfr>70; 2 when VL<100,000 c/ml
18 What to start in Resource-limited settings? Three drug combination in Naïve Patients 2 Nucleoside RT Inhibitors + NNRTI or Boosted PIs NtRTI or NRTI TDF ABC AZT NRTI + + Cytidine Analog FTC + 3TC + Third ARV EFV* RPV* Alternative ATV/r* LPV/r WHO guidelines 2013 *Thai Guidelines 2016: EFV 400, RPV for CD4>350, and ATV/r 200/100 for patients on bpis with VL<50
19 Strategy to improve tolerability Dose optimization for Thai/Asian patients
20 % of Patients % of Patients ENCORE Study: 48 Weeks 94 EFV 400 mg was non-inferior to EFV 600 mg Multi-national study: N= 630. the result was confirmed at 96 weeks follow-up study EFV 400 EFV 600 N=321 N= EFV 400 EFV 600 N=321 N= P = VL <200 c/ml VL <50 c/ml 0 EFV-AEs Encore study group. Lancet 2014; 383:
21 LASA Study: Design and Endpoints N=560 Adults age >18 Yr On boosted PI regimens for 3 mo Plasma HIV-RNA <50 c/ml for 12 mo Randomized 1:1 Stratification by sites, and use of tenofovir, indinavir PI: protease inhibitor, r: ritonavir, OD: once daily Atazanavir/r 200 /100 mg OD With 2 NRTIs Atazanavir/r 300 /100 mg OD Primary endpoint proportion of patients whose HIV-RNA <200 c/ml after 48 weeks of treatment Non-inferiority if the lower limit of the 95% CI for the difference in proportion with VF was above -10% in an ITT analysis at 48 weeks Assessments: 0, 12, 24, 36, and 48 weeks blinded bilirubin results Type analyses: intention to treat (ITT), per protocol (PP), snap shot (non-completer=failure) analysis
22 LASA Study Results at Week 48 N=560 with viral suppressed 3 months ATV/r 200 ATV/r 300 % Patients with HIV-RNA <50 c/ml % Patients Discontinuation ITT Bunupuradah T, et al. Lancet HIV NC=F P = Overall P = Clinical jaundice P =0.06
23 Cost Saving (million Baht) Cost Saving When Using Lower Dose Atazanavir (from 300 to 200 mg) 5 year savings: USD 30 million Up to 1000 million Baht To treat 5000 cases with a 10 % increase/year mg 200 mg 30 tab/bottle 1 month supply tab/bottle (2 months supply)
24 Issues on Second-line ART when prescribing boosted-protease inhibitors Kaletra Atazanavir Darunavir
25 Polypharmacy and Drug Interaction >20% taking 3 other drugs >40% taking lipid-lowering agents Always with caution when prescribing PIs, cobicistat (PK booster)
26 ระว ง ห ามทาน ยา Ergot ก บ PIs Severe AR and headcahe Is a common cause
27 Ergotism while taking bpi is not uncommon in patients who taken ergotamine without awareness WARNING Thai report N=23 All had VL<50, CD4 > hospitalization (4-20 days) 3 gangrene 2 Amputation 1death This was a HCW case was prescribed bpi as a PEP regimen Burger D, Avihingsanond A. et al 2015
28 Challenges?
29 Challenge 1 Reduce New Infection
30 Thailand Situation
31 การต ดเช อรายใหม ท กๆ 1 ช วโมงม 1 คน ต ดเช อ HIV 2 ใน 3 เก ดข น ใน 33 จ งหว ด เก ดข นมากท ส ด ในชายร กชาย 1 ใน 4 (25%) เก ดข นใน กร งเทพฯ
32 เอดส ร กษาให อย จนแก เฒ าได หากร เร วร กษาเร ว แต น าเส ยดายมาก ท ย งม คนเส ยช ว ตจากเอดส ท ก ชม. ท ก ว น die from AIDS every hour ท กๆ 1 ช วโมง จะม 2 คน ตายจากเอดส เพราะต ดเช อมานาน แต ไม เคยตรวจ จ งไม ทราบ และจ งไม มาร กษา
33 What proven work?
34 Major PrEP Studies and the Efficacy among high adherence individuals TDF/FTC regimen PrEP Pre-Exposure Prophylaxis IPERGAY MSM PROUD MSM iprex MSM Partners PrEP Heterosex. 86 % 86 % 92 % 90 %
35 Efficacy of HIV Prevention Strategies From Randomized Clinical Trials Study HPTN 052, ART for prevention; Africa, Asia, Americas Partners PrEP, PrEP for discordant couples; Uganda, Kenya TDF2, PrEP for heterosexual men and women; Botswana Medical male circumcision; Orange Farm, Rakai, Kisumu iprex, PrEP for MSMs; Americas, Thailand, South Africa Sexually transmitted diseases treatment; Mwanza, Tanzania CAPRISA 004, Microbicide; South Africa RV144, HIV vaccine; Thailand Abdool Karim SS, et al. Lancet Efficacy (%) 100 Effect Size, % (95% CI) 96 % (73-99) 73 % (49-85) 63 % (21-84) 54 % (38-66) 44 % (15-63) 42 % (21-58) 39 % (6-60) 31 % (1-51)
36 Preventing HIV Spreading Awareness Condom Use Safe-sex PreEP PEP TasP Treatment-as prevention
37 Challenge 2 Improving HIV Care Cascade
38 HIV Treatment Cascade : NAP-Plus database by 2014 HIV+ reported 445, % HIV+ recruited to care 426,274 96% ART prescribed ART retaining VL <50 copies/ml 320, , ,920 43% 58% 15% No VL test or failure 72% 14% ART dropped out 28% Pre-ART dropped out 0 100, , , , ,000 Number of cases Source: NAP-Plus, September 2014 Sirinya Teeraananchai et al. Ms in submission
39 Figure 5A Geographic information of each province categorized by % of patients who had baseline CD4 count <100 cells/mm 3 Year 2012 Year 2013 Year % n = <50% m= <40% n= 0 <30% n= 0 50% n = <50% m= <40% n= 9 <30% n= 0 50% n = <50% m= <40% n= 6 <30% n= 0 Thailand has 76 provinces in total (by 2015)
40 Figure 5C Geographic information of each province categorized by % of patients who had plasma HIV-1 RNA <50 c/ml in 1 year of ART Year 2012 Year 2013 Year 2014 <80 % n= <85 % n= <90 % n= 2 90 % n= 1 <80 % n= <85 % n= <90 % n= 3 90 % n= 0 <80 % n= <85 % n= <90 % n= 5 90 % n= 4 Thailand has 76 provinces in total (by 2015)
41 How to? or Undiagnosed HIV+
42 How to improve the uptake and coverage on both HIV prevention and treatment?
43 These situations will make us losing the battle against HIV Complacency Weak Monitoring Passive, Routine Action
44 How to win the battle? Proactive and smart implementing of combined prevention and care strategies together with the communities Treatment coverage Viral suppressed cases High Retention New infection Undiagnosed cases Poor-adhered cases Drug-resistance Cases Prevention Coverage Early Test-and-treat PrEP STI treatment
45 How to find patients in early stage of HIV infection? Passively Hospital-based Drop-in center Actively Reach-out Mobile clinics Social media Routine/ indicative screening Self-testing Community-led services
46 Multiple Strategies to get People Tested Drop in Mobile clinic Community based Homebased IPD Self-test OPD HIV Testing Routine check up
47
48 Ending HIV Stigma Social Education Service Friendly Stigma Normalizing HIV Testing Empowering Law
49 Acknowledgement to all of the HIV-NAT and TRCARC staffs, the IRBs, DSMBs, collaborators, funders and in particular to all the study participants Thai Red Cross AIDS Research Center Faculty of Medicine, Chulalongkorn University
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