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1 E AL TH R IN CT IO U S DIS S SE IN FE EA Reviews & 4 in Antiviral Therapy INFECTIOUS DISEASES 2013 IN VIR PY A TI A N & REVIEWS JOURNAL OF ABSTRACTS AND CONFERENCE REPORTS FROM INTERNATIONAL WORKSHOPS ON INFECTIOUS DISEASES & ANTIVIRAL THERAPY Abstract Book Reviews in Antiviral Therapy & Infectious Diseases 4/2013 a medical education company 7th International Workshop on HIV Treatment, Pathogenesis and Prevention Research in Resource-Limited Settings INTEREST - Workshop May 2013, Dakar, Senegal

2 Abstracts 1 7 th International Workshop on HIV Treatment, Pathogenesis and Prevention Research in Resource- Limited Settings - INTEREST May 2013, Dakar, Senegal Abstracts Oral presentation

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4 Abstracts 3 Abstract: O_01 HIV drug resistance HIV drug resistance in Senegalese pediatric population receiving first and second line antiretroviral treatment K. Kebe 1, O. Diop 1, A. Sow Sall 1, A.A.M. Diouara 1, M. Thiam 1, H. Diop Ndiaye 1, L. Belec 2, A. Dia 3, A. Signate Sy 3, Y. Bâ 4, N.Mbaye 4, S. Mboup 1, C. Toure Kane 1 1 Dakar University, Molecular Biology Unit, Dakar, Senegal; 2 HEGP, Virology Laboratory, Paris, France; 3 Dakar University, CHU FANN, Dakar, Senegal; 4 Roi Baudouin Hospital, Pediatrics, Dakar, Senegal Background: Previous studies examining ART in children infected with HIV-1 have identified several specific difficulties in treating pediatric HIV infection in sub-saharan Africa. The principal factors compromising ART efficacy in HIV-infected children include the limited number of available paediatricformulated antiretroviral drugs, the frequently observed poor adherence to drug therapy schedules, and an increased viral load, which may favour the risk of therapeutic failure and drug resistance. The aim of this study was to evaluate the rate of virological failure (VF) as well as the rate of therapeutic failure as assessed by drug resistancemutations profiles, in a cohort of HIV-1-infected children living in Dakar and receiving ART according to the World Health Organization recommendations for resourceconstrained countries. detectable HIV-1 RNA load, and 86 (51%) met the 2010-revised WHO criteria of VF (defined as plasma HIV-1 RNA load 3.7 log 10 copies/ml). Drug resistance results were available in 74 children with plasma HIV-1 RNA load 3.0 log 10 copies/ml, and viruses carrying resistance mutations were found in 66 (90%) children. Among these 66, mutations conferring resistance to nucleoside reverse transcriptase inhibitors (NRTIs) or non NRTIs were found in 57 (86%) and 67 (97%), respectively. No PI major resistance mutation was observed in our study population. Lopinavir boosted with ritonavir second line regimen was introduced for children with RTI resistance mutations. Preliminary genotypic results after at least one year under second line showed 3 children with viruses harbouring PI minor resistance mutations out of 8 children (38%). Conclusion: High rate (51%) of VF was demonstrated in Senegalese children after 20 months of first-line ART; and therapeutic failure was assessed by the presence of antiretroviral drug resistance mutations in 9 out of 10 children in VF. PI minor resistance mutations were also observed in 38% of children under PI second line regimen during at least 12 month. These findings point out the difficulties of optimizing ART in children living in Sub-Saharan Africa, and the crucial need of laboratory monitoring reinforcement.they also underline the urgent need of making available pediatric third line regimen in resource-limited settings. Method: A cross sectional study was conducted in reference and decentralized sites. Plasma HIV-1 RNA load was measured using Abbott m2000 Real Time HIV-1 assay. Full-length protease gene and partial reverse transcriptase gene were sequenced, and resistance mutations were assessed by reference to Stanford University HIV drug resistance database. Results: In this study, 125 children from the reference and 42 from decentralized sites were included. Of 167 included children (median age, 7 years) taking first-line ART for a median duration of 20 months, 108 (65%) showed

5 Abstracts 4 Abstract: O_02 Basic Science Détection par mha de doubles infections du VIH-1 chez les hommes ayant des rapports sexuels avec d'autres hommes et la population générale au Sénégal N. Leye 1, N. Vidal 2, O. Ndiaye 1, H. Diop-Ndiaye 1, E. Tchiakpé 1, A.A.M. Diouara 1, M. Thiam 1, K. Kébé 1, A. Sow 1, A.S. Wade 3, S. Mboup 1, E. Delaporte 2, M. Peeters 2, C. Touré-kane 1 1 Laboratoire bacteriologie-virologie, Biologie Moléculaire, dakar, Senegal; 2 Institut de Recherche pour le Developpement, UMI 233 Sida et maladies associées, Montpellier, France; 3 Division de Lutte contre le SIDA et les IST, Division de Lutte contre le SIDA et les IST, dakar, Senegal Introduction: Au Sénégal, l'épidémie de VIH est de type concentré et caractérisée par une grande diversité génétique. La prévalence est faible (0,7%) dans la population générale (PG) et élevée chez les hommes ayant des rapports sexuels avec d'autres hommes (HSHs) (21,8%). Le CRF02_AG est la forme génétique du VIH-1 la plus répandue dans la population générale et les femmes professionnelles du sexe, alors que le sous-type C est prédominant (45%) chez les HSHs dont 80% ont affirmé avoir des partenaires sexuelles féminines. Ces pratiques pourraient augmenter les risques de transmission de divers soustypes/crfs vers la PG féminine. L'objectif de cette étude était de déterminer et comparer les fréquences des doubles infections avec des sous-types/crfs différents du VIH-1/M dans ces deux populations. la technique ANRS. La Single Genome Amplification (SGA) a été utilisée en cas de réactions avec des sondes hétérologues pour isoler les populations virales minoritaires. Résultats: La distribution des souches de VIH-1 obtenues par séquençage et par MHA dans les deux populations a confirmé la prédominance du CRF02_AG dans la PG (61,3% vs 26% chez les HSHs) et du soustype C Chez les HSHs (45% vs 5% dans la PG). Dans la PG, 5 autres variants : A, B/D, CRF06_cpx, CRF11_cpx, CRF25_cpx et des souches (U) non classées ont été retrouvées alors que chez les HSHs seuls 3 autres soustypes B, G et CRF09_cpx ont été retrouvés. La survenue d'urfs inter-région gag-vpu était comparable dans les deux groupes (15% dans la PG vs 17% chez les HSHs, p=0,689). La fréquence des doubles infections était sept fois plus élevée dans le groupe des HSHs (39%, n=27/69) que dans la PG (5,4%, N=5/93, p=000001). Chez les HSHs, 63% (n=17/27) des co-infections ont impliqué deux souches différentes du sous-type C vs 40% (n=2/5) dans la PG. La SGA a permis d'isoler les variants minoritaires de 2 cas d'infections multiples incluant une double C+B, une triple C+C+CRF02_AG chez 2 HSHs. Elle a aussi mis en évidence la mixture de variants de VIH- 1 entre un HSH et une femme de la PG. Conclusions: Cette étude a montré une très forte proportion de doubles infections chez les HSHs. Elle a confirmé la mixture des variants de VIH-1 entre les HSHs et la PG. Ce qui augmenterait leur risque à des doubles infections. Cela démontre la nécessité d'accroître les efforts pour soutenir les programmes de prévention et de prise en charge ciblant les HSHs au Sénégal. Matériels et Méthodes: Dans cette étude rétrospective, 93 patients de la PG et 69 HSHs ont été inclus. La recherche d'infections multiples a été réalisée dans les gènes gag et vpu, en utilisant la Multi Hybridization Assay (MHA). Elle est basée sur l'utilisation de sondes fluorescentes spécifiques dans une PCR en temps réel pour détecter les variants de VIH-1/M circulant en Afrique de l'ouest et du Centre. Les réponses MHA ont été comparées avec les séquences obtenues par

6 Abstracts 5 Abstract: O_03 Antiretroviral treatment toxcities Tenofovir plasma exposures and creatinine clearance changes in 1st line regimen of African patients in Cameroon and Senegal: ANRS12115 DAYANA study M. LE 1, S. Koulla-Shiro 2, G. Peytavin 3, P. Salif Sow 4, B. Ndiaye 4, M.B. Koita Fall 4, C. Essomba 2, A. Benalycherif 5, P.M. Girard 5, R. Landman 5 1 Hôpital Bichat-Claude Bernard, Clinical Pharmacokinetic, Paris, France; 2 University of Yaounde 1 and Central Hospital, Infectious Diseases, Yaounde, Cameroon; 3 Hôpital Bichat-Claude Bernard, Clinical Pharmacokinetics, Paris, France; 4 Universitary Fann Hospital, Infectious Diseases, Dakar, Senegal; 5 Institut de Médecine et d'epidémiologie Appliquée, Infectious Diseases, Paris, France Introduction: Dayana was a randomized, open-label, non comparative, 48-weeks, prospective pilot study evaluating four 1 st line TDF containing regimens: TDF/FTC/NVP (Gp1), TDF/LPV/r (Gp2), TDF/FTC/ZDV (Gp3) and TDF/FTC/EFV (Gp4) in antiretroviral (ARV)-naïve, HIV-1-infected patients. At baseline (D0), 119 patients were included: 34% male, median plasma HIV-1-RNA (pvl): 5.4 log 10 c/ml, median CD4: 200/mm 3. At W48, pvl<50 c/ml was achieved in 77% of patients in Gp1, 41% in Gp2, 83% in Gp3 and 70% in Gp4. The objectives of this sub-study were to determine tenofovir (TFV) plasma exposures in the respective ARV regimens and to assess the relationship with creatinine clearance (CrCl). Material & Methods: ARV trough Plasma concentrations (C12h or C24h) were determined at W4 and W48 using LC-MS/MS. Median and IQR25-75% (n) were presented. CrCl were Calculated based on Cockroft-Gault (CG), Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease EPIdemiology collaboration (CKD-EPI) formulae adjusted on respective Body Surface Area. Statistical analysis was performed using Spearman and Student tests. Results: TFV-C 24h was statistically higher with LPV/r (Gp2) in comparison with the other regimens: 86ng/mL (71-111; 20) vs 38ng/mL (23-59; 164) p< Without LPV/r (Gps 1; 3; 4), 21/164 (13%) of TFV-C24h was above 80ng/mL (predictive cut-off of tubulopathy) and most of them occurred at W48. A statistically significant and inversely proportional relationship between TFV-C24h and CrCl was found at W48 whatever the formula (CG, MDRD, CKD-EPI) (p<10-5 ) but not at W4, confirming the probable cumulative mechanism of renal disease. A more pronounced decrease of CrCl (W48-D0) was observed with LPV/r compared to the other groups probably related to the higher TFV-C 24h (p=10-4. Accordingly, higher 25% decrease of CrCl (W48-D0) was observed with LPV/r (39%) vs EFV (13%) vs NVP (4%) vs ZDV (11%). ARV Ctrough (ng/ml) pooled at W4 and W48 were: ZDV-C 12h =10 (10-130, 58); G-ZDV- C 12h =30 (13-993, 58); FTC-C 24h =9 (8-10, 164); EFV-C 12h =2,042 (1,245-3,790, 67); NVP- C 12h =4,594 (3,323-7,647, 69); LPV-C 12h =5,413 (2,542-7,661, 42); RTV-C 12h =150 (97-329, 42). Most of ARV C12h or C24h determined in these African patients were consistent with data previously reported in patients from North countries and confirming the good treatment adherence of the patients enrolled in Dayana trial. Among them, approximately 20% of EFV and NVP C12h were above the thresholds of drug related toxicity 4,000 and 8,000 ng/ml, respectively. Conclusions: The determination of ARV plasma concentrations in these African patients allowed to reinforce the assessment of treatment adherence. It also permit to detect the occurrence of TFV-related renal based on CrCl changes whatever the formula (CG, MDRD, CKD-EPI) particularly in association with LPV/r via a possible inhibition of MRP2/MRP4 efflux transporters.

7 Abstracts 6 Abstract: O_04 HIV drug resistance Use of Dried Blood Spots for HIV-1 drug resistance genotyping in decentralized settings in Senegal A.A.M. Diouara 1, H. Diop-Ndiaye 1, K. Kébé 1, B. Ouattara 2, J. Da Veiga 3, M. Diouf-Sakho 2, E. Tchiakpé 1, M. Thiam 1, N. Vidal 4, A. Ayouba 4, M. Peeters 4, E. Delaporte 4, S. Mboup 1, C. Touré-Kane 1 1 Laboratoire Bactériologie-Virologie, Dakar, Dakar, Senegal; 2 Centre de Santé Roi Baudouin, Guédiawaye, Dakar, Senegal; 3 Hôpital Saint Jean de Dieu, Thiès, Thiès, Senegal; 4 UMI 233 «VIH/SIDA & Maladies Associées» IRD 911 avenue Agropolis, Hérault, Montpellier, France Introduction: Antiretroviral therapy (ART) coverage in sub Saharan Africa was around 56% allowing a reduction by 32% the number of deaths related to HIV/AIDS from 2005 to However, this benefit could be compromised by drug resistance emergence. A structured virological monitoring by plasma viral load (VL) quantification and genotyping could predict this emergence. Due to technical requirements generally needed, the availability of plasma viral load and drug resistance genotyping in resources limited-settings remain a challenge particularly in decentralized areas. The aim of this study was to demonstrate the benefit of DBS collected in remote areas and sent under field conditions to a reference laboratory for HIV-1 VL determination and drug resistance testing in patients with suspected treatment failure. and the Microsoft Excel function statistic category. Results: A total of 285 patients on ART (21 children and 264 adults) were included in the study. Among them, 252 (88%) were on regimen not containing PI and 33 (12%) on PI containing regimen. The median time on ART was 18 months (range 6-72). The overall rate of virological failure (VL 3log 10 cp/ml) in patients on HAART containing PI or not was 15.1% (5/33) and 25.7% (65/252) respectively. HIV genotypes were successfully obtained in 95.7% (67/70). At least one DRM was found in 50/70 (71.4%) with 2/5 patients on PI containing regimen and 48/65 on regimen without PI. The main DRM detected were distributed as follows: M184V/I (n=28), TAMs (n=43) and T69N/P (n=2) for NRTI and K103 (n=21), K101E (n=16), V106M/A (n=16), Y181C (n=8) and Y188L/H (n=7) for NNRTI. No major PI resistance mutation was observed in amplified samples both in PI treated patients or not. Among the 67 genotyped samples, phylogenetic analysis showed the predominance of CRF02_AG with 64.17% (43/67). Other subtypes found were A3 (n=2, 3%), B (n=2, 3%), and one representative of the each following subtype/crfs: G, CRF06_cpx, CRF01_AE and CRF49_cpx. Unique recombinant forms (URFs) were found in the proportion of 23.8% (n=16). Conclusions: Use DBS specimen is suitable to assist national programs for viral load quantitation, drug resistance genotyping and care of patients followed in remote areas in Senegal and other resource limited-settings. Materials & Methods: DBS collected from patients receiving ART at decentralized settings were sent within 15 days maximum to the reference laboratory. HIV-1 RNA was quantified using the NucliSENS EasyQ HIV-1 v1.2 (BioMérieux). Partial pol gene was sequenced using the ANRS protocol. Drug resistance mutations (DRM) were analyzed according to the Stanford University HIV database v Nucleotides sequences alignments and phylogenetic tree was done on Clustal X v1.83 software and recombinant analysis was performed with SimPlot v3.5.1 software. Statistical calculations were performed using SPSS v16.0, Epi Info v3.5.4

8 Abstracts 7 Abstract: O_05 HIV and other STD's Human papillomavirus genotype distribution in invasive cervical cancer in sub-saharan Africa: could HIV explain the differences? C. Ndiaye 1, L. Alemany 2, N. Ndiaye 3, B. Kamaté 4, Y. Diop 5, M. Odida 6, K. Banjo 7, S. Tous 2, J.E. Klaustermeier 2, O. Clavero 2, X. Castellsagué 2, F.X. Bosch 2, H. Trottier 1, S. de Sanjosé 2 1 Université de Montréal, Department of Social and Preventive Medicine, Montreal, Canada; 2 Institut Català d'oncologia, Unit of Infections and Cancer, Barcelona, Spain; 3 Université Cheikh Anta Diop, Department of Anatomy and Pathology, Dakar, Senegal; 4 Université de Bamako, Department of Anatomy and Pathology, Bamako, Mali; 5 Hôpital Principal, Department of Anatomy and Pathology, Dakar, Senegal; 6 Makerere University, Department of Pathology, Kampala, Uganda; 7 Lagos University Teaching Hospital Idi-Araba, Department of Pathology, Lagos, Nigeria Background: Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide and the causal factor of cervical cancer. In sub-saharan Africa (SSA), cervical cancer is the most common cancer in women with an estimated 75,000 new cases and 50,000 deaths each year. HIV infection has been strongly associated with higher prevalence, higher incidence and persistence of HPV infection, and progression of squamous intraepithelial lesions to cancer. More importantly, invasive cervical cancer (ICC) was classified as an AIDS-defining disease by the Centers for Disease Control and Prevention. Objective: To compare HPV type-specific relative contribution (RC) in ICC in 5 sub- Saharan African countries according to HIV prevalence. by reverse hybridization line probe assay (LiPA 25 ). Data from 3 other SSA countries (Mozambique, Nigeria and Uganda) and 35 countries around the world, which followed the same study protocol were extracted from de Sanjosé et al. (Lancet Oncology 2010). Ecological HIV prevalence for each SSA country was retrieved from UNAIDS 2009 report. Estimates and Spearman correlations between HIV and RC of HPV16, HPV18 and HPV45 in ICC were calculated. Results: A total of 711 women from the 5 SSA countries were included in the analyses. In SSA countries, HPV16 was less frequent than in the rest of the world (49.4% vs. 62.6%; P < ) but HPV18 and HPV45 were two times more frequent (19.3% vs. 9.4%; P < and 10.3% vs. 5.6%; P < , respectively). We found a positive ecological correlation between HIV prevalence and the RC of HPV18 (r=0.9; n=5; p=0.037) and a negative ecological correlation between HIV prevalence and the RC of HPV45 (r=-0.9; n=5; p=0.037) in SSA countries. The RC of HPV16 was not correlated with HIV prevalence (p=1.0). Finally, ICC with HPV16, HPV18 and HPV45 infections were diagnosed at younger age than ICC with other HPV types in HIV endemic countries. Conclusions: The comparison between SSA countries and other regions of the world suggests that the development of cancer of the cervix is promoted in a context of high HIV prevalence. Our findings suggest that HIV may play a role in the underlying HPV18 and HPV45 contribution to cervical cancer, but further studies are needed to confirm this correlation. Immunosuppression induced by HIV infection may induce more chances of HPV18 to escape immunity barriers, to persist and to develop neoplasia. This accelerated progression could potentially explain increasing numbers of ICC diagnosed at a younger age in high HIV prevalence areas. Material and methods: A multicentric study was conducted in Mali and Senegal to collect paraffin-embedded blocks of ICC diagnosed between 2006 and HPV DNA detection was performed by SPF10 broad-spectrum PCR followed by deoxyribonucleic acid enzyme immunoassay (DEIA) and genotyping

9 Abstracts 8 Abstract: O_06 Late Breaker Tuberculosis mycobacteremia as a cause of severe sepsis in HIV-infected patients in Lusaka, Zambia L. Muchemwa 1, B. Andrews 1, S. Lakhi 1, A. Kruuner 2, J. Mwaba 3, G. Bernard 4 1 University Teaching Hospital, Internal Medicine, Lusaka, Zambia; 2 University Alabama Birmingham, AL, Birmingham, USA; 3 University Teaching Hospital, Pathology, Lusaka, Zambia; 4 University New Mexico, I Medicine, Albuquerque, USA Background: Although tuberculosis (TB) bloodstream infections have been well described among febrile patients in sub- Saharan Africa, very little information is available regarding tuberculosis mycobacteremia in critically ill patients presenting with severe sepsis. Methods: This was an observational substudy of a pilot randomized controlled trial conducted in Lusaka, Zambia. The parent study evaluated a bundled treatment protocol versus usual care for patients admitted with severe sepsis. Patients were eligible for inclusion if they had severe sepsis defined as infection, 2 or more criteria of systemic inflammatory response syndrome, and endorgan dysfunction. Mycobacterial and aerobic blood cultures were collected from 82 HIV seropositive participants. Positive mycobacterial cultures were examined by gram stain and acid fast staining, and TB speciation was confirmed by MPT64 antigen. In-hospital and 30-day outcomes were recorded. Results: 31 of 82 participants (37.8%, 95%CI %) had positive mycobacterial blood cultures, all of which were identified as M. tuberculosis. In-hospital mortality was 71.0% in the TB mycobacteremia group and 60.8% in the non-tb group (OR 1.17, p=0.35). Median CD4 count was significantly lower in the TB bacteremia group (24.5 vs. 73, p=0.002). Two (6.5%) of the 31 patients with TB bacteremia had concomitant Staphylococcus aureus bacteremia. Only 13 (41.9%) of those with TB bacteremia were treated for TB during the hospitalization. 30 (96.8%) of 31 TB bacteremia patients and 49 (96.1%) of 51 nonmycobacteremic patients had at least one of the following symptoms for greater than two weeks: cough, fever, night sweats, or weight loss. Chief complaints were similar between those with and without mycobacteremia. Illness severity was similar, with median SAPS3 score of 61 in the TB bacteremia group and 58 in the non-tb group (p=0.17). Conclusion: Tuberculosis mycobacteremia prevalence is very high in critically ill HIV positive patients presenting with severe sepsis in Lusaka, Zambia. Mortality in these patients exceeds 70%, in part because of lack of TB recognition and treatment. Disseminated tuberculosis should be suspected in all HIV positive patients with low CD4 counts from Southern Africa presenting with severe sepsis. New diagnostic methods or a lower threshold for empiric treatment mat be necessary in order to reduce the mortality due to TBassociated severe sepsis.

10 Abstracts 9 7 th International Workshop on HIV Treatment, Pathogenesis and Prevention Research in Resource- Limited Settings - INTEREST May 2013, Dakar, Senegal Abstracts Poster presentation

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12 Abstracts 11 Abstract: PP_01 Late Breaker Durability of initial ART regimens and predictors of regimen modification among adult patients receiving HIV care in Nairobi, Kenya L. Mwakisachi 1, M.N. Armes 2, J. Penner 3, J. Lewis-Kulzer 2, B. Chiboli 1, S.B. Shade 2, C. Blat 2, C.R. Cohen 2, C. Mwachari 1 1 Kenya Medical Research Institute, Center for Respiratory Diseases Research, Nairobi, Kenya; 2 University of California San Francisco, Departments of Obstetrics Gynaecology and Reproductive Sciences, California San Francisco, USA; 3 University of British Columbia, Department of Family Practice, Canada, Canada Background: In resource-limited settings, a critical goal for anti-retroviral therapy (ART) is to maintain patients on their initial fully suppressive regimen for as long as possible (and as long as it is suppressive), before switching to regimens that are often more expensive, less well tolerated, and have higher pill burden. Data on durability of initial ART regimens and predictors of regimen modification in sub-saharan Africa are scarce. This study sought to examine time to regimen modification and predictors of modification among adults newly initiated on ART. Materials & Methods: Adult patients initiated on first-line ART between January 2005 and August 2010 at two Family AIDS Care and Education Services supported clinics in Nairobi, Kenya, were retrospectively evaluated using routine clinical data. Patients were included if they were ART-naïve at enrollment and active in care for >3 months after ART initiation. ART was initiated based on CD4 count and/or WHO clinical stage per Kenyan National Guidelines. Clinical and laboratory data were collected at baseline and each follow-up visit. Regimen modification was defined as any sustained drug change to a patient s initial ART regimen. Time-to-event analysis was performed using a Cox proportional hazards model to determine predictors of ART regimen modification. Potential predictors included patient demographic and clinic characteristics at time of ART initiation. Patients were censored at date of confirmed pregnancy, loss to follow-up, transfer-out, confirmed death, ART discontinuation, or end of study period (August 30, 2011). Results: Among 1,634 patients initiated on first-line ART, 1,510 (92%) were evaluable. Median age was 37 years (IQR 32-43) and the majority (62%) were female. At initiation, median CD4 count was 175 (IQR ), 44% of patients were in WHO stage III or IV, and median BMI was 21.9 (IQR ). For initial ART regimens, 99% of patients were on 3TC, the most common other NRTI was d4t (57%), and the most common NNRTI was NVP (60%). Over a median follow-up period of 25 months (IQR 14-36), total regimen modification was 37%. Median time to ART modification was 45 months (IQR 25-69). Males as well as individuals in WHO stage IV at baseline in comparison to those in WHO Stage 1, were less likely to have regimen modification (AHR 0.73, 95% CI ) and (AHR 0.59, 95% CI ) respectively. In contrast, baseline BMI <18.5 was associated with a higher rate of modification (AHR 1.36, 95% CI ). At baseline, d4t had an increased hazard of ARV modification compared to AZT (AHR 1.79, 95% CI ). This hazard is dependent on time and increases overtime; 6 months past baseline, the adjusted hazard ratio was 2.16 (95% CI ). Conclusions: These findings demonstrate a reasonable durability of initial ART regimens among adults in a resource-limited setting. A low BMI, female gender, and starting a d4tbased regimen were predictors of regimen modification, and hazard of modification increased with duration of d4t exposure. Additional studies are needed to determine if regimen modifications can be minimized by selecting individualized initial regimens based on the known predictors for modification.

13 Abstracts 12 Abstract: PP_02 Late Breaker High level resistance to didanosine observed in South African children failing an abacavir or stavudine based first-line regimen. K. Steegen 1, L. Levin 2, I. Ketseoglou 1, M. Bronze 1, S.C. Carmona 3, M.A. Papathanasopoulos 1, W.S. Stevens 1 1 University of Witwatersrand, Haematology and Molecular Medicine, Johannesburg, South Africa; 2 Right To Care, Johannesburg, South Africa; 3 National Health Laboratory Services, Haematology and Molecular Medicine, Johannesburg, South Africa Background: In 2010 the preferred 1 st -line regimen for children in South Africa was changed from d4t/3tc to ABC/3TC-based regimens, whereas the 2 nd -line regimen is based on AZT/ddI. This study investigated the suitability of the 2 nd -line regimen for children in the context of ARV drug resistance patterns emerging after 1 st -line virologic failure. Methods: A retrospective dataset of 370 ARV drug resistant genotypes from children, identified as virological failures on either ABC (n=91) or d4t (n=279) based regimens, was analysed. Samples were sent to the HIV genotyping laboratory at Charlotte Maxeke Johannesburg Academic Hospital for routine testing between 2009 and Obtained pol sequences were submitted to the Stanford HIV database for genotypic predictions. Results: Patients had an average VL of 4.6 log10 RNA copies/ml with a median age of 8 years and were exposed to ABC or d4t-based regimens for an average of 21 and 36 months, respectively (p<0.0001). Complete susceptible drug resistance profiles were observed in 11.0% and 2.1% in the ABC and d4t group respectively (p=0.0011). These wild-type genotypes were excluded from further analysis. Predictably, most patients (n=316, 89.3%) developed M184V/I conferring resistance to 3TC. At time of failure, children exposed to ABC demonstrated high level resistance to ABC (n=50, 61.7%). An additional 19 children developed intermediate resistance to ABC (n=19, 23.5%). Development of high-level and intermediate cross-resistance to ABC in the d4t exposed group was observed in 22 (8.1%) and 235 (86.1%) children respectively. A large proportion of children remained susceptible to d4t regardless of exposure to ABC (n=63, 77.8%) or d4t (n=204, 74.7%) (p= ). The majority of children remained fully susceptible to AZT after exposure to ABC (n=72, 88.9%) and d4t (n=217, 79.5%, p=0.0712). The prevalence of complete susceptibility to TDF was significantly larger in the d4t group (n=214, 78.4%) compared to the ABC group (n=44, 54.3%, p<0.0001). The frequency of reduced susceptibility to ddi was substantial in the ABC exposed group: 49 (60.5%) and 7 (8.6%) children developed high level and intermediate resistance to ddi respectively. Resistance to ddi was commonly attributed to L74V/I mutation (n=44). Despite the lower rate of high-level ddi resistance after exposure to d4t (n=25, 9.2%) an important proportion of these patients still developed intermediate resistance to ddi (n=93, 34.1%). Development of TAMs was did not seem to be affected by the NRTI backbone. Conclusion: Analysis reveals that the currently recommended 2 nd line regimen for children in South Africa is far from ideal, given the high frequency of cross-resistance to ddi observed at 1 st line failure; especially after ABC exposure. Based on observed resistance profiles, a combination of AZT and recycled 3TC may provide a superior 2 nd line backbone for patients failing both ABC and d4t-based regimens. Whereas in older patients, a combination AZT and TDF would be suitable for those exposed to d4t. The data presented provides some evidence for the need to revise current paediatric antiretroviral treatment guidelines in South Africa.

14 Abstracts 13 Abstract: PP_03 Late Breaker Daily Infant Nevirapine (NVP) through Six months of Life for Prevention of Mother-to-Child Transmission of HIV-1 (PMTCT) - Adherence and NVP Exposure J. Aizire 1, E. Capparelli 2, C. Herron 3, E. Brown 3, H. Coovadia 4, A.C. Desmond 5, S. Eshleman 6, B. Maldonado 7, K. Manji 8, M.G. Fowler 9, M. Mirochnick 10, J. Aizire 11 1 MU-JHU Research Collaboration, 046 STUDY PROMISE STUDY, Kampala, Uganda; 2 University of California San Diego San Diego CA US, NA, San Diego CA, USA; 3 Fred Hutchinson Cancer Research Center Seattle WA US, NA, Seattle WA, USA; 4 Maternal & Child Health University of Witwatersrand South Africa, NA, Durban, South Africa; 5 Centre for the AIDS Programme of Research in South Africa (CAPRISA) Nelson R Mandela School of Medicine University of KwaZulu Natal, NA, Durban, South Africa; 6 Johns Hopkins University School of Medicine, NA, Baltimore MD, USA; 7 Stanford University School of Medicine, NA, Stanford CA, USA; 8 Muhimbili University of Health and Allied Sciences, NA, Dar es Salaam, Tanzania; 9 Johns Hopkins University, NA, Baltimore MD, USA; 10 Boston University School of Medicine, NA, Boston MA, USA; 11 Makerere Uni Johns Hopkins Uni, NA, Kampala, Uganda Introduction: Adherence to infant NVP for PMTCT is crucial to ensure effectiveness, and can be assessed by plasma NVP concentrations. We report the relation of infant plasma NVP concentrations to infant HIV infection status in a large randomized African trial (HPTN 046), which compared the efficacy of 6 weeks versus 6 months of daily infant NVP dosing for PMTCT. recorded at each visit. Fisher s exact test was used to compare reported adherence in uninfected and infected infants. Results: Eight (1.1%) of 727 infants randomized to the NVP arm became HIV infected between 6 weeks and 6 months of age; 1 infant whose mother was on antiretroviral therapy at randomization was excluded. NVP concentrations were available from 7 infected (of these 1 excluded from analysis due to missing data) and 21 matched uninfected infants. Infant birthweight, gender, maternal CD4 at randomization and age at weaning were similar in infected and uninfected infants. Maternal-report of poor adherence to infant dosing (missed 1 dose since the previous visit) at month 3 was higher among infected infants, although not statistically significant: 4 (66.7%) vs. 9 (42.9%), respectively, P=0.39. No significant differences were observed among infected and uninfected infants at week 8 and month 3 in either median (range) of plasma NVP concentration or proportion with NVP concentration 100 ng/ml (target for effective PMTCT). Conclusion: Infants with reported missed NVP doses had lower plasma NVP concentrations than those with no reported missed doses. However, there was no difference in median NVP concentration at week 8 and month 3 among infected infants and uninfected controls. Plasma NVP concentrations effective for PMTCT did not differ significantly between infected and uninfected infants. We conclude that infant infection was not explained by low plasma NVP concentrations in the first several months of life. Materials and Methods: We compared all HIV-infected infants who received 6 months of NVP with a matched group of uninfected infants (1:3 ratio). Plasma samples at week 8 and month 3 were assayed for NVP concentration by high pressure liquid chromatographic/mass spectroscopy. HIV-1 DNA Polymerase Chain Reaction assays were performed at 2 and 5 weeks, and at 3, 6, 9, and 12 months. Maternal self-reported adherence to administering infant NVP was

15 Abstracts 14 Abstract: PP_04 HIV epidemiology Growth among HIV infected children receiving antiretroviral therapy in Dar es Salaam, Tanzania R. Mwiru 1, D. Spiegelman 2, C. Duggan 3, G. Seage 2, H. Semu 4, G. Chalamilla 5, R. Kisenge 6, W. Fawzi 7 1 Management and Development for Health, Nutrition, Dar es Salaam, Tanzania; 2 Harvard School of Public Health, Epidemiology, Boston, USA; 3 Harvard School of Public Health, Nutrition, Boston, USA; 4 Ministry of Health and Social Welfare, Nutrition, Dar es Salaam, Tanzania; 5 Management and Development for Health, MDH, Dar es stunting at ART initiation (P<0.001) were associated with increased risk of lower HAZ score profiles. Significant predictors of lower WHZ/BMIZ scores were male sex (P=0.04), advanced WHO disease stage (P<0.001), older age (P=0.04), TB infection (P=0.004), and wasting at ART initiation (P <0.001). Stavudine containing regimens on the other hand were associated with favorable WHZ/BMIZ scores. Conclusions: These findings suggest that, additional interventions such as nutritional support may be needed for children on ART to ensure that the growth of these children is optimized to the greatest extent possible. Salaam, Tanzania; 6 Muhimbili University of Health and Allied Sciences, Pediatrics, Dar es Salaam, Tanzania; 7 Harvard School of Public Health, Global Health and Population, Boston, USA Background: A common feature of human immunodeficiency virus (HIV) infection in children is disturbance in growth. Despite the magnitude and duration of the HIV epidemic in Sub-Saharan Africa, there is limited data on growth among pediatric patients receiving antiretroviral therapy (ART). Materials and Methods: The study involved 3144 children under the age of 15 years, initiating ART between 2004 and 2010 in Dar es Salaam, Tanzania. The prospective relationships of growth and baseline as well as time-varying covariates were examined using the Generalizing Estimating Equations. Results: We observed that the mean weightfor-age z scores (WAZ) and height-for-age z scores (HAZ) increased steadily after ART initiation then levelled off after about 6 months of treatment. Weight-for-height and body mass index z scores (WHZ/BMIZ) on the other hand though lower than WAZ and HAZ throughout, showed a steady increase over the entire period of follow-up. Children were at increased risk of lower WAZ score profiles if they were underweight at ART initiation (P<0.001), had advanced WHO disease stage (P<0.001), had TB infection (P=0.04), if they had lower CD4+ T cells level (P=0.001), anemic (P<0.001), or older than 5 years (P for trend=0.09). In addition, use of cotrimoxazole (P=0.01), and

16 Abstracts 15 Abstract: PP_05 HIV drug resistance Monitoring Virologique du traitement antirétroviral chez des patients VIH-1 suivis en milieu décentralisé au Sénégal, Mali et République de Guinée A.A.M. Diouara 1, I. Guindo 2, N. Bangoura 3, H. Diop- Ndiaye 1, N. Leye 1, O. Ndiaye 1, K. Kébé 1, A. Sow 1, N. Vidal 4, A. Ayouba 4, M. Peeters 4, E. Delaporte 4, S. Mboup 1, C. Touré-Kane 1 1 Laboratoire Bactériologie-Virologie, Dakar, Dakar, Senegal; 2 Laboratoire de bactériologie virologie INRSP, Bamako, Bamako, Mali; 3 Laboratoire CTA, Conakry, Conakry, Guinea Conakry; 4 UMI 233 «VIH/SIDA & Maladies Associées» IRD 911 avenue Agropolis, Hérault, Montpellier, France Introduction: Le suivi virologique des patients constitue un véritable challenge et particulièrement en zones décentralisés dans le pays en développement. L objectif de cette étude était de documenter l utilisation des DBS (Dried Blood Spot) comme support de prélèvements pour des tests de charge virale et de génotypage de résistance du VIH-1. Méthodes: L étude a porté sur des patients sous traitement ARV depuis au moins 6 mois et suivi en milieu décentralisé au Sénégal, au Mali et en République de Guinée. Les DBS ont été collectés et acheminés dans un délais maximal de 30 jours des sites de prise en charge vers le laboratoire de référence (LBV- HALD) situé à Dakar puis stockés à -80 C jusqu à leurs utilisations. Les acides nucléiques ont été extraits selon la technologie de Boom (Biomérieux) et les charges virales quantifiées soit avec la plateforme de BioMérieux (NucliSens EasyQ HIV-1 v2.0) soit avec m2000rt d Abbott Diagnostics (HIV-1 Real-Time ). Les échantillons en rebond virologique (CV 1000 copies/ml) ont fait l objet de tests résistance selon le protocole de l ANRS. L analyse et l interprétation des mutations de résistance ont été faites sur l algorithme de Stanford (HIV db algorithm V6.0.8). Sénégal, 7 au Mali et 4 en Guinée. Au total, 432 patients répartis comme suit : 132, 164 et 136 respectivement pour le Sénégal, le Mali et la Guinée ont été inclus dans cette étude. Le sexe ratio Homme/Femme varié de 0.25, à Et les patients sous première ligne de traitement (2 INTI + 1 INNTI) étaient de 97% à 94,8% avec des médianes de suivi allant de 32 à 39 mois. L échec virologique (CV 1000 copies/ml) observé était de 29,5% (n=39), 10,9% (n=18) et 24,2% (n=33) respectivement pour le Sénégal, le Mali et la Guinée. Les taux respectifs de succès du génotypage sont de 82% (32/39), 77,7% (14/18) et 84,8% (28/33) pour le Sénégal, le Mali et la Guinée. Au moins une mutation de résistance aux ARV a été décelé chez les patients en échec virologique, soit des taux de résistance globale de 15,9% (21/132), 8,5% (14/164) et 16,1% (22/136) respectivement pour le Sénégal, le Mali et la Guinée. L analyse des mutations a montré la fréquence des mutation suivantes : M184V (14, 11 et 11); TAMs (34, 15 et 28) pour les INTI; K103N (6, 6 et 8) ; Y181C (5, 6 et 4) pour les INNTI respectivement pour le Sénégal, le Mali et la Guinée. Aucune mutation de résistance aux IP n a été observée chez les patients Guinéens. Au Sénégal et au Mali, 1 patient de chacun de ces pays présentait au moins une mutations aux IP. Conclusion: Ces résultats montrent que l utilisation des DBS comme support de prélèvement pourrait contribuer au bon monitoring virologique et prise en charge des patients sous ARV suivis en zone décentralisée dans les pays à ressources limitées. Résultats: Le recrutement des patients a été effectué au niveau de 9 sites décentralisés au

17 Abstracts 16 Abstract: PP_06 HIV-2 infections Infection à VIH-2 au Sénégal: Echecs virologiques a M12 et M24 et limites des options thérapeutiques de seconde ligne S. Ba 1, N.M. Dia 1, L. Fortes 1, C.T. Ndour 1, M. Toure 1, P.S. Spw 1, G.S. Gottlieb 2 1 Service maladies infectieuses du CHUN de FANN, Dakar, Dakar, Senegal; 2 Université de Washington, Washington, Seattle, USA Introduction: Le VIH-2 est naturellement résistant aux inhibiteurs non nucléosidiques de la transcriptase inverse, ce qui rend difficile la prise en charge de l'infection dans un contexte de pays à moyens limités, surtout en cas d échec du traitement de première ligne. et M24 dont 28 en échec virologique (21 à M12 et 7 à M24), soit une prévalence de 30% et 11%. Des résistances génotypiques aux INRT ont été notées dans 33%, aux IP dans 33% (31/96) et des multi résistances aux INRT et IP dans 30%(28/96) des cas.. La létalité a été de 3% (M12) et 2,8%(M24) le taux de perdus de vus de 10% (M12) et 3%(M24) Conclusion: L inaccessibilité des nouveaux IP et des inhibiteurs de l intégrase n offrait aucune option de deuxième ligne aux patients en échec, qui ont été laissés sous le traitement initial puisque la seule alternative pour le traitement de 2eme ligne reste au Sénégal l Atazanavir boosté. Un accès plus étendu des nouvelles molécules s avère aujourd hui nécessaire pour assurer une bonne prise en charge des patients infectés par le VIH-2 Objectifs: Evaluer la prévalence des échecs thérapeutiques de première ligne chez le patient infecté par le VIH-2 et argumenter les options de deuxième ligne Méthodologie: C est une étude descriptive longitudinale et prospective, débuté en octobre Etait inclus tout patient infecté par le VIH-2, âgé de 18 ans ou plus, sous traitement antirétroviral de première ligne, et consentant à participer à l étude. Après inclusion le suivi était régulier au premier mois puis tous les quatre mois L échec virologique a été défini comme toute charge virale supérieure a 50 copies/ml. Résultats: Au total 96 patients ont été colligés, d âge médian de 49 ans, avec un ratio F/H de 1,8. A l inclusion, 31% des patients étaient symptomatiques, classés au stade 4 de l OMS, avec un IMC médian de 19,7 kg/m2.. L immunodépression était globalement sévère avec un taux de LT CD4+ inferieur à 200 cellules /mm3 dans 88% des cas. Le schéma antirétroviral associait 2INRT à 1IP dans 96% des cas. Sur les 96 patients, 44 (45,8%) ont débuté un traitement à base d indinavir non boosté, seul IP disponible aux débuts de l ISAARV, avant d être mis sous lopinavir/ritonavir. Au total, 70 puis 60 patients ont respectivement complété leur bilan de M12

18 Abstracts 17 Abstract: PP_07 HIV drug resistance Résistance secondaire aux antirétroviraux et diversité génétique chez les patients HIV1 mauritaniens de la cohorte nationale. Z. Fall Malick 1, S.A. Ould Soufiane 2, H. Diop-Ndiaye 3, M.V. Ould Abdallahi 2, A. Ould Ebaye 4, E. Tchiapé 5, A. Ould Horma 6, B. Lo 7, S. Mboup 5, C. Touré-Kane 5 1 Laboratoire de Virologie de l'institut National de Recherches en Santé Publique Nouakchott / Mauritanie) / Laboratoire de Bactériologie Virologie A. Le Dantec de Dakar., Biologie moléculaire, Dakar, Senegal; 2 Centre Hospitalier National de Nouakchott., Centre de Traitement Ambulatoire, Nouakchott, Mauritania; 3 Laboratoire de bactériologie Virologie A. Le Dantec de Dakar, Biologie moléculaire, Dakar, Senegal; 4 Ministère de la Santé, Unité Sectorielle de Lutte contre le SIDA, Nouakchott, Mauritania; 5 Laboratoire Bactériologie VIrologie A Le Dantec, Biologie moléculaire, Dakar, Senegal; 6 Hôpital de l'amitié, Service de Gastro-entérologie, Nouakchott, Mauritania; 7 Faculté de Médecine, Biologie, ouakchott, Mauritania Problématique: La résistance aux antirétroviraux (ARV) constitue un problème de santé publique. En Mauritanie la cohorte nationale était constituée de 2997 patients dont 1667 sous ARV (mars 2010). Les ARV ont été introduits dans le pays en 2004 et la charge virale en Le taux de résistance secondaire et la diversité génétique chez les patients sous traitement sont méconnus. L objectif de cette étude est d évaluer pour la première fois les profils de résistance secondaire et la diversité génétique des souches VIH-1 chez des patients mauritaniens sous traitement antirétroviral pour lesquels un échec virologique a été observé. Matériels et Méthodes: L étude a porté sur 86 patients en échec virologique (CV>1000copies/ml) recrutés entre janvier 2009 et mars L ARN a été extrait par le kit QIamp viral RNA de QIAGEN, amplifié et séquencé selon la technique ANRS sur des fragments du gène pol (totalité protéase et 240 premiers acides aminés de la Transcriptase Inverse). Pour l exploitation des données, les logiciels suivants ont été utilisés : Clustal X1.83 et Simplot 2.6 pour la phylogénie, Excel et SPSS 16.0 pour l analyse statistique. L analyse des mutations de résistance a fait recours au site de Stanford (http://hivdb.stanford.edu/). Résultats: Sur les 1667 patients sous ARV, 144 (%) sont décédés et 377(%) perdus de vue, seuls 86 patients en échec virologique on fait l objet de cette étude dont 58 hommes, 28 femmes. La médiane d âge était de 35 ans. Au moment de l échec virologique, la médiane de suivi était de 32 mois avec une charge virale de 4,85 log copies/ml. Les lignes thérapeutiques étaient composées de 2 molécules d INRT associées soit à 1 INNRT (n=79) ou à 1 IP (n=7). Pour l instant 51 échantillons ont pu être amplifiés. L analyse phylogénétique a révélé 34 CRF02_AG, 3 CRF_06cpx, 1CRF11_cpx, 4 A3, un représentant des sous types B, C et G, et 6 recombinants uniques. Parmi les patients en échec virologique, 37 présentaient au moins une mutation de résistance à une classe d ARV dont 27/37 aux INRT, 32/37 aux INNRT et 23/37 à une double mutation de résistance (INRT+INNRT). Parmi les 7 patients sous IP, 1 présentait des mutations de résistance à cette classe d ARV. La mutation M184V et TAMs ont été retrouvés respectivement chez 26 et 13 patients. Parmi ceux présentant des TAMs, 1 patient cumulait les TAMs et la K219E. Pour les INNRT, les mutations K103N et/ou Y181C ont été retrouvées chez 32 patients. Les mutations de résistance aux IP retrouvées chez le patient, parmi les 7 sous traitement de 2ème ligne étaient la M46I, I54V, V82A et L10I. Conclusion:Nos résultats ont montré un taux de résistance élevé parmi les patients mauritaniens en échec virologique. De plus, ce travail a permis de déceler un taux de décès précoce et de perdus de vue élevé. Il est alors nécessaire de mettre en place un suivi immuno-virologique structuré incluant le test génotypique de résistance et un dispositif d aide à l observance pour une meilleure prise en charge.

19 Abstracts 18 Abstract: PP_08 High risk populations: epidemiology and prevention Prevalence of anal intraepithelial neoplasia in HIV positive men who have sex with men attending comprehensive care clinics in Nairobi. E.W. Njagi 1, L.W. Muchiri 1 1 University of Nairobi, Human Pathology, Nairobi, Kenya Background: Men who have Sex with Men (MSM) populations exist in virtually all cultures and communities. Men who have sex with Men have a heavy burden of HIV and associated conditions including anal squamous cell carcinoma and its precursor lesions. High risk Human Papilloma Virus (HPV) infection associated causally with both invasive squamous carcinoma and its precursor lesions has been identified in 70% of all MSM irrespective of HIV status. Highly Active anti- Retroviral Therapy (HAART) does not significantly alter the pathogenesis of anal squamous intrapithelial lesion (ASIL), HPV infections or squamous cell carcinoma (SCC). As more and more HIV positive MSM continue to live longer due to HAART, the prevalence of ASIL, HPV infections and SCC is expected to rise. It is expected that screening with the aim of detecting early precursor lesions and treating them before they become invasive cancer will reduce the prevalence, morbidity and mortality associated with invasive squamous cell carcinoma. Screening using pap smears is expected to achieve similar success to that of cervical pap smears. practice and medical history. Conventional smears were prepared for anal cytology and stained with Papanicolau stain. Slides were reviewed by the principal investigator and two cytopathologists. In case of any discrepancy, a tie-breaker reviewed the slides. Setting: Casino Special Treatment Center clinic and Kenyatta National Hospital Cytology Laboratory. Results: Ninety four eligible participants who gave consent were included in the study. Forty, (44%) showed normal anal cytology, 51 (56%) had abnormal anal cytology as follows: Atypical squamous cells of undetermined significance (ASC-US), 16(17.6%), low grade squamous intraepithelial lesion (LSIL), 29 (31.8%) and high grade squamous intraepithelial lesion (HSIL) 6 (6.6%), while 3 (3.2%) had unsatisfactory smears. candida was the most frequent organism accounting for 77%. I. butschlii cysts were observed in 11% of smear, while coccobacilli were in 6% of smears. Conclusion: The prevalence of AIN is high, among HIV positive MSM in Kenya, similar to that reported in western countries. Recommendation: Routine screening for high- risk MSM is recommended, and screening and treatment for candidiasis, an opportunistic infection in HIV positive persons should be done. Objective: To determine the prevalence of anal intraepithelial neoplasia in HIV positive Men who have Sex with Men (MSM) attending comprehensive care clinics in Nairobi. Design and methods: A cross sectionaldescriptive study was done. A total of ninety four HIV positive MSM who met the inclusion criteria were recruited using respondent-driven sampling, and completed a questionnaire, detailing their socio-demographic data, sexual

20 Abstracts 19 Abstract: PP_09 The Burden of Tuberculosis in HIV-infected Patients who died while on Antiretroviral Therapy (ART) in western Kenya An Autopsy Study F. Some 1, A. Gardner 2, A. Mwangi 3, D. Chumba 4, M. Karoney 5, P. Koskei 5, I. Mauled 5, K. Kenina 5, A. Siika 6 1 Moi University School of Medicine, Medicine, Eldoret, Kenya; 2 Moi University & Indiana University School of Medicine, Medicine, Eldoret Indianapolis, Kenya; 3 Moi University School of Medicine, Behavioural Sciences, Eldoret, Kenya; 4 Moi University School of Medicine, Human Pathology, Eldoret, Kenya; 5 AMPATH, Moi University Clinical Research Centre, Eldoret, Kenya; 6 Moi University School of Medicine, Medicine, Eldoret, Kenya Background: Globally, tuberculosis (TB) is a leading cause of death in those with HIV infection particularly in Sub-Saharan Africa (SSA). Antiretroviral therapy (ART) is associated with reduction in the incidence of TB. Identifying the causes of death and characterizing the pattern of TB in HIV deaths in western Kenya would provide information that could be used to mitigate TB death in HIV. Materials and Methods: AMPATH enrolled HIV-infected patients who died while on ART were studied. Detailed pathological autopsies were performed on non-embalmed bodies within 72 hours of death. Body tissue and fluid specimens harvested at autopsy underwent histological, hematological, and microbiological tests. Specimens taken from cerebrospinal fluid, bone marrow, lung tissue, hilar lymph node, spleen, and adrenal gland were cultured on Lowenstein-Jensen media. Mycobacterium tuberculosis (MTB) speciation was confirmed using Capilia testing. Chi Square and Kruskal Wallis statistical tests were used for analysis of comparative data (p-value < 0.05 being significant). Other causes were pulmonary, central nervous system and gastrointestinal conditions; malignancies, septicemia, kaposi sarcoma, cardiomyopathy, malaria and anemia. TB was found in 119 (52.4%) autopsy cases; 49 (21.6%) had definite TB (at least one positive culture), 45 (19.8%) had probable TB (positive histology/afb smear), 25 (11.0%) had possible TB (gross pathologic features i.e. tubercle, cavity). In additional 24 (10.6%) patients were on TB treatment at the time of death for a median duration of 9.5 weeks (IQR 3, 21.2). Those with definite or probable TB had a lower median CD4 cell count, were more likely to be male and were more likely to have died in hospital (p < 0.05). There were 21 (9.3%) cases of isolated pulmonary tuberculosis (PTB), 31 (13.7%) of extrapulmonary tuberculosis (EPTB) and 67 (29.5%) cases of combined PTB and EPTB. Of those with at least one culture positive for MTB, 41 (83.7%) had evidence of TB in more than one anatomic site. Conclusions: Tuberculosis is highly prevalent in HIV patients who died while on ART in western Kenya. Late presentation to care with low CD4 cell count, male sex, and being hospitalized are significantly associated with TB at death, with extra pulmonary manifestation of TB being common. Early diagnosis and initiation ART in HIV patients as well as aggressive diagnosis and treatment of TB, may improve outcome of HIV patients in resource-limited settings such as Kenya. Results: Pathological autopsies and tissue studies were performed in 227 bodies (61.2% female) over a period of 24 months. At the time of death, median age was 40.1 years; median CD4 cell count closest to death was 95; all the patients were on ART and median duration of ART was 10.2 (IQR 2.2, 29.4) months. The main contributing cause of death was TB.

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