Improving the treatment follow up of HIV/AIDS patients Implementation of HIV-1 Viral Load testing

Transcription

1 17/05/2011 ë Improving the treatment follow up of HIV/AIDS patients Implementation of HIV-1 Viral Load testing Pensières, Sept Dr Phimpha Paboriboune phimpha@ccm-laos.org

2 Plan 1. HIV/AIDS situation in Lao PDR -National recommendations for screening test, ARV treatment and VL testing 2. History of implementation HIV VL in Centre Christophe Mérieux. 3. Samples reception 4. Latest data at CCML 5. Perspectives 2

3 HIV/AIDS situation in Lao PDR Total Population 6.5 M HIV prevalence estimated 0.3% (2009), people are living with HIV. The first HIV identified on 1990 The first AIDS identified 1992 Cumulative number of HIV/AIDS from /2010: Number of province reported 17 Number of patients registered : 3030 Number of patient under ARVs: Source of information: Center for HIV/AIDS/STI

4 National Recommendations (1) 1. Screening test : 2 rapid tests : Determine VIH 1/2 and Unigold VIH 1/2. If discordant result : confirm by WB. 2. ARV treatment : 1 st /2 nd line are available in Laos. When to start? New recommendation (2009) : CD4 350cells/mm 3, or WHO clinical stage 3 or 4 irrespective of CD4 cell count. What to start? 1 st line regimen Preferred regimen - AZT + 3TC + EFV/NVP - TDF + 3TC + EFV/NVP Alternative regimen - d4t + 3TC + EFV/NVP - ABC + 3TC + EFV/NVP 2nd line regimen A boosted protease inhibitor (bpi) plus two NRTIs are recommended for second-line ART. ATV/r and LPV/r are the preferred bpi. Simplification of second NRTI options is recommended 4 Source of information: Center for HIV/AIDS/STI

5 National Recommendations (2) 3. CD4 and Viral Load monitoring a) CD4 machines are available in 2 AIDS treatment Centers in Vientiane (Mahosotand Setthathirath), once in the south (Savannakhet). The CD4 count test will be done every 6 months. b) Viral Load testing : 6 months after HAART initiation Then, 1 VL/year (excepted if any suspicion of treatment failure) When VL detectable on HAART, boost adherence and re-test VL after 3 months If VL remains detectable, switch to 2nd line or resistance genotype (if available) 5

6 History of HIV-1 Viral load implementation Before may 2009, the tests were performed in Thailand (expensive and complex logistics). Originally, the implementation was planed in Mahosothospital by ESTHER project. But the lack of appropriate infrastructure, human resources etc. Meetings/discussions between partners : CHAS, WHO, ESTHER, Pasteur Institutof Cambodia (IPC), AFD, Fondation Mérieuxto implement this testing at Centre Christophe Mérieux (CCML). On 25 June 2009, technical transfer to CCML from IPC (Dr Eric Nerrienet). The technique used at the CCML was developed by ANRS (Agence Nationale de Recherche sur le SIDA, France) AC11/AC12; Biocentric(Real- Time RT-PCR). MoUbetween CHAS & CCML signed on 6 August

7 Quality control : CCM Inte r labo reproductibility 7,0 6,5 R 2 = 0,9611 6,0 5,5 5,0 4,5 4,0 3,5 3,0 2,5 2,0 2,0 3,0 4,0 5,0 6,0 7,0 IPC Intra labo reproductibility 7,0 R 2 = 0,9859 6,5 6,0 5,5 5,0 4,5 4,0 3,5 3,0 2,5 2,0 2,0 2,5 3,0 3,5 4,0 4,5 5,0 5,5 6,0 6,5 7,0 R u n 1 Result comparison of RNA plasmatic VL of HIV patients from Laos vscambodia 2009 : EQC IPC/CCML Oct 2010 : C.T.C.B a Toulouse; 7

8 Organized National Workshops 1 st : On Nov : for clinicians/technicians lab, sample collection and shipment, interpretation of results, treatment follow-up, information form of patients. 2 nd : On Mai 2010 : for clinicians/labs, Introducing of HIV-1 RNA VL and virologic escape. 3 rd planed on 2 nd week of Nov : ARV drugs resistance, cases study 8

9 Samples reception ARVsTTT Centers Days send By Spmt Bokéo Tuesday plane-1h plasma LNT Wed avion-1h Plasma/ EDTA LPB Wed avion-1h plasma Savanh Tuesday Bus-8h plasma Paksé Tuesday Bus-11h plasma Mahosoth Monday EDTA Settha Monday EDTA Results sent every 2 nd and 4 th week of month 9

10 TechnicalProcedure atcentre Christophe Mérieux o Protocol: 1. Blood withdrawal 2. Shipment to the laboratory 3. Extraction of viral RNA 4. Reverse-transcription into DNA 5. Quantification by amplification (Real-Time RT-PCR) o Specificity of test Specificity = VIH-1 Sensitivity = 250 RNA copies (200 of µl plasma) o The price actually is 25$ per test. o Support by Global Found & ESTHER 10

11 Latest data: 6/09-31/08/2010 On 31 August, 975 samples received at CCML, 100% were validatedand analyzed, representing 853 patients. Among them, 46,4% (n=396) were women. Median age is 35 yo. Age group Freq. Percent 1. Age 2-6 yo 2. Age < 2 yo 3. Age > Co-infection reported Tuberculosis Hepatitis B HBV+TB Hepatitis C PCP CMV % 2,2% (n=19) 1,6% (n=14) 0,35% (n=3) 0,12% (n=1) 0,35% (n=3) 0,12% (n=1) 11

12 juillet août 12 Samples received Total juin janv-10 fevrier mars avril mai 1 st workshop 2 nd workshop Total juin-09 juillet aout septembre octobre novembre décembre

13 Monitoring VL testing in AIDS TTT Centers Hospitals NbP registered NbP under ARV (Data 08/2010) NbP beneficed on 1 st VL (31/8/10) Under ARV No ARV Bokeo (77.7%) 1 Setthathirath (34.1%) 32 Savanakhet (53.2%) 1 Mahosot (50%) 73 Luang Namtha (75%) 3 Luang Prabang (46.4%) 4 Mother / Children Paksé (9.6%) 0 Total (43%)

14 ARVsregimes Among 853 patients, 86,5% (n=738) were under ARVs: 96% (n=710) on 1st line, 4% (n=28) on 2 nd line. Median duration on 1 st line is 3.1 y (±1.87) and on 2 nd line 3.6 y (±1.61) 6% 5% 3% d4t; 3TC + NVP 3TC; AZT+ NVP 11% 8% d4t; 3TC+LPV 11% d4t; 3TC+ EFV 3TC; TDF/AZT + LPV/RTV 57% 3TC; ABC+ NVP 22% 59% 3TC; ABC/ddI+ LPV 18% 3TC; TDF+ EFV 3TC; d4t+nvp or 3TC; AZT+EFV or 3TC; ABC+ EFV ddi; ABC+ LPV/RTV or d4t; AZT + LPV or d4t; 3TC+LPV. 14

15 Patients under ARVs follow up 738 patients 1 st VL check up Undetectable 84%(n=622/738) Detectable 16% (118/738), with VL median 5 Log and Median duration of TTT is 2,8 y 2 nd VL after adherence boosted n=30/118 Undetectable 60% (n=18/30) Detectable 40% (12/30) 15

16 Patients with 2 detectable VL on HAART ARV regimen : 11 patients have ARVs1 st line since 2004 (d4t; 3TC+NVP, 3TC; AZT+ NVP, 3TC; TDF+NVP) 1 patient on 2 nd line (TDF; ABC+LPV/r) since With VL median 4,8 Log 58% (n=7) are women; with median age 33 yo 16

17 Conclusion The implementation of HIV RNA VL assay (Biocentric): Encourage patients with undetectable VL to stay adherent Monitor treatment failures Early Infant Diagnosis (6 weeks-18 months) Strengthen the activity of HIV/AIDS Treatment Centers Provide Monitoring/Evaluation indicators for the National Program The results showed the importance to check the adherence in all patients with detectable VL, thanks to meeting or workshop every 6 months. 17

18 Perspectives Technique transfer of genotype testing from IPC to CCML is on going Participate whit CHAS to write National Guideline Develop database for HIV VL Assay In 2011 to develop the early diagnosis of HIV infection in the newborn 18

19 Khopchailai lailai lai! CCML team CHAS Fondation Mérieux Institut Pasteur Cambodia ESTHER EHESP, Alexia Kieffer OMS AFD/GB AIDS Treatment Centers 19