1. THE 6 TH NATIONAL SCIENTIFIC CONFERENCE ON HIV/AIDS The acquired HIV drug resistance among HIV adults receiving ART at least 36 months in Vietnam Vũ Quốc Đạt 1, Đỗ Thị Nhàn 2, Nguyễn Hữu Hải 2, Trương Thị Xuân Liên 3, Nguyễn Thị Lan Anh 4, Huỳnh Hoàng Khánh Thư 3, Nguyễn Trần Hiển 4, Lương Quế Anh 3, Dương Thị Thu Thủy 4, Đỗ Thị Ngọc Thảo 3, Tạ Thị Thu Hồng 4, Nguyễn Vũ Thượng 3, Đỗ Huy Dương 4, Trần Phúc Hậu 3, Khưu Văn Nghĩa 3, Nguyễn Duy Phúc 3, Phạm Thị Minh Hằng 3, Nguyễn Thị Thúy Vân 5, Bùi Đức Dương 2, Masaya Kato 5 1 Hanoi Medical University (HMU) 2 Viet Nam Administration of HIV/AIDS Control (VAAC) 3 Pasteur Institute (PI) – Ho Chi Minh city 4 National Institute of Hygiene and Epidemiology (NIHE) 5 World Health Organisation (WHO)

2. The 6 th National Scientific Conference on HIV/AIDS Outline 1.Background 2.Objectives 3.Methods 4.Results & Discussions 5.Conclusions

3. The 6 th National Scientific Conference on HIV/AIDS Background The surveillance of acquired drug resistance is essential in context of rapid ART scaling up. The study aims to estimate representative prevalence of viral load suppression and HIV drug resistance among individuals who started ART ≥ 36 months in Vietnam.

4. The 6 th National Scientific Conference on HIV/AIDS Objectives 1. Prevalence of viral load suppression (VL<1000 copies/mL) among individuals sampled who have been on ART ≥ 36 months –Prevalence of viral load suppression (VL<1000 copies/mL) among individuals sampled who have been on first-line ART ≥ 36 months 2. Prevalence of HIV drug resistance among individuals sampled who have been on ART ≥ 36 months 3. Prevalence of HIV drug resistance among individuals sampled with viral load >1000 copies/mL who have been on ART ≥36 months –Prevalence of HIV drug resistance among individuals sampled with viral load >1000 copies/mL who have been on first-line ART ≥ 36 months

5. The 6 th National Scientific Conference on HIV/AIDS Survey Population Participant inclusion criteria –HIV (+) Individuals who provide informed consent –Adults who are 18 years of age or older who have been on ART for at least 36 months at the time of clinic visit, regardless of site of therapy initiation. Participant exclusion criteria –Individuals with HIV-2 or HIV-1/HIV-2 co-infection, if information available

6. The 6 th National Scientific Conference on HIV/AIDS Methods A cross-sectional surveys using cluster sampling The sampling frame is the list of all adult ART clinics in Vietnam by the end of 2010 where patients receiving ART Probability proportional to proxy size (PPPS) sampling –A likely proxy is the total eligible number of patients on ART for ≥ 36 months at each clinic that as of December 2010. –This number of patients is proxy population size will be used for sampling. –In PPPS sampling, the probability that a clinic is sampled is proportional to the size of the proxy patient population.

7. The 6 th National Scientific Conference on HIV/AIDS Methods We planed to sample n=16 clinics without stratification assumes that prevalence of viral load suppression of 70% for the 36+ month time point, and desires a confidence interval length of ±7%, assume laboratory failure rate of 15% The actual sample size of 368

8. The 6 th National Scientific Conference on HIV/AIDS Methods Until 12/2010, there was total of 217 ART clinics with 48.606 patients on ART by 2010 throughout Vietnam Sampling frame consist of 216 eligible clinics, exclude: –9 pediatric ART clinics –4 military ART clinics and 3 interim ART offices under Department of Labor, War Invalids and Social Affairs without tracking system (consists of 494 patients) To enhance the geographic representativeness of the sample, clinics are listed by geographic area before using systematic sampling for generating probability proportional to size sample

9. The 6 th National Scientific Conference on HIV/AIDS Study locations Name of OPC Name of province No. of active ART pts by end of 2010 RegionLevel Required sample OPC of Health Center, Thanh hoa cityThanh Hoa395MidDistrict23 Quang Ninh Provincial Hospital OPCQuang Ninh984NorthProvincial23 Dong Da hospital OPCHa Noi583NorthDistrict23 Yen Bai provincial hospital OPCYen Bai478NorthProvincial23 Vietnam-Sweden Friendship Hospital, Uong Bi OPCQuang Ninh330NorthNational23 Health Center, Tu Liem district OPCHa Noi250NorthDistrict23 OPC of the Health Center, Thai Nguyen cityThai Nguyen178NorthProvincial23 Health Center, Thanh Xuan district OPCHa Noi101NorthDistrict23 Tropical Diseases HospitalHCMC3334SouthProvincial23 Binh Thanh district OPCHCMC1146SouthDistrict23 District 6 OPCHCMC1033SouthDistrict23 District 2 OPCHCMC963SouthDistrict23 Phu Nhuan preventive medicine center OPCHCMC530SouthDistrict23 Dong Thap Provincial AIDS prevention centerDong Thap386SouthProvincial23 Vinh Long provincial hospital OPCVinh Long322SouthProvincial23 Kien Giang provincial hospital OPCKien Giang180SouthProvincial23 TOTAL368

10. The 6 th National Scientific Conference on HIV/AIDS Methods Specimens with a VL of ≥1000 copies/mL were genotyped to determine HIVDR status in the two laboratories accredited by WHO for National HIV Drug Resistance laboratory (NIHE and Pasteur Institute). HIVDR genotypic test was conducted on pol gene with the ABI 3130XL system using the Big-Dye Terminator v3.1 Cycle Sequencing Kit (Applied Biosystem, California, USA). HIVDR was interpreted with the HIValg program in the Stanford HIV drug resistance database.

11. The 6 th National Scientific Conference on HIV/AIDS Results A total of 368 patients with HIV was recruited from 16 clinics throughout the country. –Three were excluded because of the violation of the inclusion criteria of ART duration of at least 36 months. The final number of 365 PLHIV was eligible for analysis –365 patients receiving viral load testing –20 patients failure to viral load suppression –19 patients with any drug mutation

12. The 6 th National Scientific Conference on HIV/AIDS Results CharacteristicNTotal sampled patientsNPts with any mutation All participants36519 Age in years (CI95%)36538.0 (37.3 - 38.7)1938.1 (35.4 -40.7) Sex Male24767.7%1368.4% Female11832.3%631.6% HIV risk exposure Injecting drug use14138.6%947.4% Heterosexual20155.1%947.4% Homosexual10.3% Others or unknown226%15.2% Length of ART Median (IQR)36575 (56-90)1965 (57-85) 36 month - 47 months3810.4%210.5% 48 months - 71 months12935.3%842.1% ≥ 72 months19854.3%947.4% Characteristic of study population

13. The 6 th National Scientific Conference on HIV/AIDS Results CharacteristicN Total sampled patients NPts with any mutation Pre-treatment CD4 cell count (cells/µL) Median (IQR)351105 (47-189)19124 (43-179) <10016647.3%842.1% ≥10018552.7%1157.9% Pre-treatment immunodeficiency classification by CD4 count 351 Normal (CD4 ≥500)72.0%00 Mild (CD4 350-499)185.0%00 Advanced (200-349)5315.2%421.1% Severe (CD4<200)27377.8%1578.9% Characteristic of study population (cont.)

14. The 6 th National Scientific Conference on HIV/AIDS Results CharacteristicN Total sampled patients NPts with any mutation Most recent CD4 cell count (cells/µL) Median (IQR)362421 (295-590)19250 (115-320) <10071.9%315.8% ≥10035598.1%1684.2% Current immunodeficiency classification by CD4 count 362 Normal (CD4 ≥500)13637.6%210.5% Mild (CD4 350-499)9927.4%15.3% Advanced (200-349)9225.4%842.1% Severe (CD4<200)359.6%842.1% Characteristic of study population (cont.)

15. The 6 th National Scientific Conference on HIV/AIDS Results CharacteristicN Total sampled patients N Pts with any mutation Initiating ART regimen NNRTI regimen36499.7%19100% PI regimen10.3% 0 0 Current ART regimen NNRTI regimen34594.5%19100 PI regimen205.5%00 Characteristic of study population (cont.)

16. The 6 th National Scientific Conference on HIV/AIDS Results Objectives%95%CI 1. Prevalence of viral load suppression (VL<1000 copies/mL) among individuals sampled who have been on ART for at least 36 months at the time of the clinic visit 95.192.3-96.9 a. Prevalence of viral load suppression (VL<1000 copies/mL) among individuals sampled who have been on first-line ART for at least 36 months 92.989.2-95.4 2. Prevalence of HIV drug resistance among individuals sampled who have been on ART for at least 36 months 4.62.8-7.5 3. Prevalence of HIV drug resistance among individuals sampled with viral load >1000 copies/mL 94.864.3-99.4 a. Prevalence of HIV drug resistance among individuals sampled with viral load >1000 copies/mL who have been on first-line ART for at least 36 months 93.959.8-99.4 Prevalence of viral load suppression and HIV drug resistance

17. The 6 th National Scientific Conference on HIV/AIDS Results Resistance profile among mutations

18. The 6 th National Scientific Conference on HIV/AIDS Results Level of resistance among RT mutations

19. The 6 th National Scientific Conference on HIV/AIDS Conclusions This is the first survey to describe acquired HIV drug resistance status using nationally representative sample in Vietnam. The results suggest a low acquired HIV drug resistance prevalence of 4.6% and high viral load suppression rate of 95.1% among patients who initiated ART for at least 36 months

20. The 6 th National Scientific Conference on HIV/AIDS Thank you for your attention! Acknowledgment –Viet Nam Administration of HIV/AIDS Control (VAAC) –Pasteur Institute (PI) – Ho Chi Minh city –National Institute of Hygiene and Epidemiology (NIHE) –World Health Organisation (WHO)