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Abstracts and Conference Reports from International Workshops on Infectious Diseases & Antiviral Therapy L A T R I H V E I T R N A A P Y N I REVIEWSI in Antiviral Therapy N S I E Reviews N S F A E 2013 C SE INFECTIOUS DISEASES &TIOUS DI & 7 JOURNAL OF ABSTRACTS AND CONFERENCE REPORTS FROM INTERNATIONAL WORKSHOPS ON INFECTIOUS DISEASES & ANTIVIRAL THERAPY Abstract Book Reviews in Antiviral Therapy & Infectious Diseases 5th International Workshop on HIV Pediatrics 28 - 29 June 2013, Kuala Lumpur, Malaysia 7/2013 a medical education company Abstracts 1 th 5 International Workshop on HIV Pediatrics 28 – 29 June 2013, Kuala Lumpur, Malaysia Abstracts Oral presentations Reviews in Antiviral Therapy & Infectious Diseases – Volume 7: 2013 Abstracts 2 Reviews in Antiviral Therapy & Infectious Diseases – Volume 7: 2013 Abstracts 3 Abstract: O_01 129/145 (89%) by pill count. Median daily LPV dose was 543 (447-619) mg/m2/day. Median Treatment of pediatric HIV infection trough plasma LPV concentration was 6.7 (4.1- 9.6) mg/L in 61 children with available samples. Median LPV hair concentrations were Lopinavir hair concentrations 5.43 (3.21 - 9.01) when VL was >1000 and predict virological failure 9.96 (6.51 - 12.31) ng/mg of hair when VL was among Asian children <1000 copies/mL. Plasma and hair LPV levels were not strongly correlated (Pearson’s correlation coefficient = 0.20; p=0.13). In 1 1 2 W. Prasitsuebsai , S.J. Kerr , T.H. Khanh , J. univariate models, age, sex, body surface 1 3 4 5 Ananworanich , D.C. Viet , L.N. Van , N. Kurniati , P. area, LPV plasma trough level and <95% 6 7 8 Kosalaraksa , V. Sirisanthana , K. Chokephaibulkit , N. adherence were not associated with VF. LPV 1 9 1 Thammajaruk , T. Singtoroj , S. Teeraananchai , M. hair concentrations categorized into quartiles 10 9 Gandhi , A.H. Sohn was significantly associated with VF (p for trend = 0.004). Compared to children in the 1 The HIV Netherlands Australia Thailand Research lowest quartile, the odds of VF were reduced 2 Collaboration, Medicine, Bangkok, Thailand; Children's by 75% (odd ratio [OR] 0.25; 95% confidence Hospital Number 1, Pediatrics, Ho Chi Minh City, Vietnam; interval [CI] 0.06 – 0.99) in those with LPV hair 3 Children's Hospital Number 2, Pediatrics, Ho Chi Minh concentrations between the 25th-50th 4 City, Vietnam; National Hospital of Pediatrics, Pediatrics, percentiles, and the odds of VF were identical 5 Hanoi, Vietnam; Cipto Mangunkusumo General Hospital, and reduced by 84% (OR 0.16; 95% CI 0.03 – 6 Pediatrics, Jakarta, Indonesia; Faculty of Medicine 0.79) in the highest two quartiles. Results for Srinagarind Hospital, Pediatrics, Khon Kaen, Thailand; hair were similar when controlled for any of the 7 Research Institute for Health Sciences, Medicine, Chiang other predictors in multivariate models. Mai, Thailand; 8Faculty of Medicine Siriraj Hospital, 9 Pediatrics, Bangkok, Thailand; TREAT Asia/amfAR—The Conclusions: Monitoring antiretroviral levels Foundation for AIDS Research, TREAT Asia, Bangkok, in hair can be a useful and sensitive strategy 10 Thailand; University of California, Medicine, San for identifying non-adherent children at risk for Francisco, USA VF. Background: Protease inhibitor (PI) levels in No conflict of interest hair reflect drug uptake from the systemic circulation over the preceding months, and may be useful in assessing long-term exposure to antiretrovirals and the risk of treatment failure. Methods: Children starting or already on PI- based second-line antiretroviral therapy (ART) were enrolled in a resistance monitoring study in three Southeast Asian countries. Viral load (VL), 30-day visual analogue scales (VAS), pill counts, and lopinavir (LPV) concentrations in plasma and hair were assessed at week 24 after enrollment, using high-performance liquid chromatography in plasma and liquid chromatography/tandem mass spectrometry in hair. Logistic regression was used to evaluate factors predicting virologic failure (VF; VL >1000 copies/mL). Results: Of 149 children, 47% were female; median (IQR) age was 10.3 (7.9-13.3) years. Median duration of LPV-based ART was 2.9 (1.6-4.2) years, during which time 17 (11%) children experienced VF. Adherence was >95% in 135/148 (91%) by VAS and in Reviews in Antiviral Therapy & Infectious Diseases – Volume 7: 2013 Abstracts 4 3 Abstract: O_02 4.62 log10 c/mL and 1192.6 cells/mm , respectively. Using modified intent-to-treat Treatment of pediatric HIV infection based on the Week 48 ATV powder cohort, at Week 48, 61% of subjects had HIV RNA <50 c/mL, and 74% had HIV RNA <400 c/mL. Viral PRINCE1: Safety and efficacy suppression rates increased with higher of ATV powder and RTV liquid baseline weight bands (48%, 68%, and 71% of in HIV-1-infected ART-naïve subjects had HIV RNA <50 c/mL in the 5-<10 kg, 10-<15 kg, and 15-<25 kg bands, and experienced infants and respectively, and 67%, 74%, and 86% of children 3 months to 6 years of subjects had HIV RNA <400 c/mL in the 5-<10 age kg, 10-<15 kg, and 15-<25 kg bands, respectively). Viral suppression did not differ significantly between ART-experienced and - 1 2 3 R. Strehlau , A. Liberty , A. Pena Donati , P. Martinez naïve subjects, with 60% and 62%, 4 5 6 7 6 Arce , J. Lissens , R. Yang , D. Butcher , S. Biguenet respectively, having an HIV RNA <50 c/mL, and 75% and 74%, respectively, with an HIV 1 Rahima Moosa Mother&Child Hospital, Empilweni RNA <400 c/mL. Mean HIV RNA change from Services and Research Unit, Coronationville, South Africa; baseline was -2.66 log10 c/ml (-2.61, -2.93, and 2Chris Hani Baragwanath Hospital, HIV Research Unit, -2.40 log10 c/mL in the 3 increasing weight 3 Soweto, South Africa; Hospital Sotero Del Rio, Infectology bands). Mean CD4 cell count change from 4 Unit, Santiago, Chile; Hospital Civil Fray Antonio Alcade, baseline was 396.5 cells/mm3 (respectively Infectious Diseases and Pediatric HIV Clinic, Guadalajara, 550.1, 225.3 and 373.8 cells/mm3 in the 5-<10 5 Mexico; Bristol-Myers Squibb, Global Development kg, 10-<15 kg, and 15-<25 kg bands). No new 6 Clinical Operations, Braine-l'Alleud, Belgium; Bristol- or unexpected safety events occurred and no Myers Squibb, Research and Development, Wallingford deaths were reported after enrollment. Five 7 CT, USA; Bristol-Myers Squibb, Research and subjects (9%) discontinued due to AEs. SAEs Development, Plainsboro NJ, USA were reported in 11 subjects (20%). Through Week 48 on ATV powder, AEs occurred in 93% of subjects; the most common being Background: PRINCE 1 is an ongoing phase upper respiratory tract infections, diarrhea and 3b prospective, international, multicenter, vomiting. nonrandomized, two-stage clinical trial assessing safety and efficacy of once daily Conclusions: ATV powder boosted with RTV atazanavir (ATV) powder and ritonavir (RTV) liquid once daily plus optimized dual NRTI liquid plus optimized dual NRTI background background therapy was effective and well therapy in antiretroviral treatment (ART)-naïve tolerated in this ART-naïve or -experienced and -experienced HIV-1-infected children ≥3 pediatric population aged ≥3 months to < 6 months to < 6 years of age. years with no new safety findings compared to what has been found in previous ATV pediatric Materials & methods: ART-naïve or - and adult studies. experienced (without prior exposure to ATV) HIV-1-infected children with screening HIV No conflict of interest RNA ≥1000 c/mL were enrolled. Stage 1 dosing regimens of ATV powder boosted with RTV liquid were based on 3 weight bands (5- <10 kg, 10-<15 kg, and 15-<25 kg). Treated subjects transitioned into Stage 2 after 48 weeks on ATV powder or upon reaching the age of 6 years or a weight ≥25kg. Efficacy and safety through Stage 1 are presented. Results: Of 56 treated subjects, 46 completed Stage 1 and 45 entered Stage 2. The majority of subjects (68%) were from Africa. Median age at baseline was 28.5 months (range 3-65 months) and 61% were ART-naïve. Mean baseline HIV RNA and CD4 cell counts were Reviews in Antiviral Therapy & Infectious Diseases – Volume 7: 2013 Abstracts 5 Abstract: O_03 ABC+3TC plus either efavirenz (60%), lopinavir/ritonavir (37%), or nevirapine (3%). Baseline median (IQR) CD4 count was Treatment of pediatric HIV infection 3 841(580-1073) cells/mm . All children completed both PK samplings visits Pharmacokinetics of abacavir without serious adverse events. In overall, and lamivudine once- versus geometric mean AUC0-24 for once- and twice- twice-daily in HIV-infected Thai daily ABC were 14.43 and 10.65 mg·h/l (GMR 1.36, 90%CI 1.11-1.66), and 17.70 and 18.11 children mg·h/l for 3TC (GMR 0.98, 90%CI 0.79-1.20), respectively. By comparing in each weight 1 2 3 P. Punyahotra , T. Bunupuradah , T.R. Cressey , A. band, AUC0-24 of once-daily ABC were higher Srimuan2, N. Thammajaruk2, J. Sophonphan2, C. than twice-daily in weight band 14-<20 kg Sriheara2, T. Puthanakit4, J. Ananworanich5 (p=0.01). Once-daily and twice-daily 3TC AUC0-24 were not significantly different in all 1Chulalongkorn University, Department of Pediatrics weight bands (all p>0.3). 2 Faculty of Medicine, Bangkok, Thailand; the Thai Red In overall, the GMR (90%CI) of ABC Cmax for Cross AIDS Research Centre, HIV-NAT, Bangkok, once- and twice-daily regimens was 2.84 Thailand; 3Program for HIV Prevention and Treatment, (2.18-3.71). Moreover, the GMR (90%CI) of Faculty of Associated Medical Sciences, Chiang Mai, 3TC Cmax for once- and twice-daily regimens Thailand; 41. Chulalongkorn University Department of was 1.69 (1.29-2.20).
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