Virologic suppression outcomes of second-line antiretroviral therapy in a Nigerian cohort.

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1 TUPE089 Virologic suppression outcomes of second-line antiretroviral therapy in a Nigerian cohort. Authors: Adedotun A. Adetunji 1, MBChB, MSc; Chad Achenbach 2, MD, MPH; Joseph Feinglass 3, PhD; Kristin M. Darin 2, PharmD; Kim Scarsi 2, PharmD, MSc; Ernest Ekong 4, MD, MPH; Babafemi Taiwo 2, MBBS; David O. Olaleye 5, DVM, PhD; Isaac F. Adewole 6, MBBS; Robert L. Murphy 2, MD. Author Affiliations: 1. Department of Family Medicine, University College Hospital, Ibadan. 2. Division of Infectious Diseases, Feinberg School of Medicine, Northwestern University, Chicago. 3. Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago. 4. AIDS Prevention Initiative in Nigeria (APIN), Abuja. 5. Department of Virology, College of Medicine, University of Ibadan. 6. Department of Obstetrics and Gynaecology, College of Medicine, University of Ibadan.

2 Introduction Nigeria has the second largest number (estimated at 3.1 million) of people living with HIV/AIDS in sub- Saharan Africa 1. Nigeria Egypt South Africa Kenya Africa ; HIV Prevalence(%) 2 <1% 1 - <5% 5 - <10% 10 - <20% 20 28% Highly active antiretroviral therapy (HAART) was introduced into Nigeria in In the AIDS Prevention Initiative in Nigeria (APIN) PLUS program, patients who develop virologic failure during first-line antiretroviral therapy (ART) with a nonnucleoside reverse transcriptase inhibitor (NNRTI)-based regimen are switched to a ritonavirboosted protease inhibitor (PI/r)-based regimen for second-line treatment. This retrospective study was carried out at the University College Hospital (UCH), Ibadan, a PEPFAR-supported APIN site in south-western Nigeria.

3 Materials and Methods We analyzed a Nigerian cohort of 225 patients for proportion with undetectable HIV RNA viral load (VL) by six months and one year following initiation of PI/rbased second-line ART, as well as factors associated with virologic suppression at these time points. Aggregated data was obtained from an electronic database including sociodemographic information, data on patient s clinic visits, monthly antiretroviral drug refill, and laboratory results of CD4 cell count and viral load tests every six (6) months. We utilized logistic regression to estimate multivariate odds ratios (OR), with 95% confidence intervals (CI) associated with an undetectable VL at 6 months and 1 year of PI/r-based therapy. P < 0.05 was considered statistically significant.

4 Eligibility criteria Confirmed HIV-infected adults (>18 years old). Initiation of NNRTI-based first line ART between January 2006 and December Confirmed virologic failure (two consecutive VL >1000 copies/ml) after at least 6 months of NNRTI-based first line ART. Treatment switch to PI/r-based regimen for at least one year. Available VL results at 6 months and 1 year of PI/r-based secondline ART.

5 Primary outcome measure The primary outcome measure was proportion of patients with undetectable HIV RNA viral load (VL < 400 copies/ml) by six months and one year of boosted protease inhibitor-based antiretroviral therapy. We defined virologic failure as two consecutive VL > 1,000 copies/ml after at least six months of non nucleoside reverse transcriptase (NNRTI)-based antiretroviral therapy.

6 Dichotomized study covariates Covariate Value Definition Sex Age m/f < 35 years Switch VL <5 log 10 copies/ml VL at point of treatment switch from first-line ART to PI/r-based second-line ART Switch CD4 + cell < 200 cells/mm 3 CD4 + cell count at point of treatment switch from count first-line ART to PI/r-based second-line ART Nadir CD4 + count < 100 cells/mm 3 Lowest ever CD4 + cell count during ART Duration of preswitch virologic failure < 180 days Time interval from the first of 2 consecutive VL >1000 copies/ml (after at least 6 months of first-line ART) until regimen switch to PI/r-based ART. PI/r adherence < 90% Percentage of actual versus expected pharmacy refills of PI/r-based regimen during the first year of second-line ART.

7 Results Of 225 patients, 212 (94.2%) had complete data on all variables. 65% of patients were women. Median age was 34 years (IQR 29, 40). 73% (164/225) and 27% (61/225) were treated with nevirapinebased, and efavirenz- based first-line regimens, respectively. 99% received boosted lopinavir (LPV/r)-based regimens. Median switch viral load: 4.6 log 10 copies /ml (IQR 3.9, 5.2) Median duration of pre-switch virologic failure was 258 days (IQR 112, 379).

8 Proportion of study patients with Results continued (a) Switch VL < 5log 10 copies/ml. (b) Duration of pre-switch virologic failure < 180 days. (c) PI/r adherence > 90%. (a)switch viral load VL < 5 log 10 copies/ml VL 5 log 10 copies/ml (b) Duration of pre-switch virologic failure 180 days >180 days (C) Protease inhibitor regimen adherence. 90% adherence <90% adherence 35.60% 64.40% 61.80% 38.20% 22.70% 77.30% χ 2 : p = 0.04 χ 2 : p = 0.02 χ 2 : p = 0.01

9 Proportion (%) of patients who achieved undetectable VL at 6 months & 1 year of PI/r-based second-line treatment Undetectable viral load 100% PATIENTS (%) 80% 60% 40% 20% 0 6 months 12 months At 6 months and 1 year of PI/r-based therapy, 78.7% (177/225) and 84.9% (191/225) respectively of the cohort reached the primary outcome of undetectable VL.

10 Logistic Regression Results Logistic regression results for achieving undetectable viral load at six months and one year of protease inhibitor-based ART for 225 included patients Patient characteristics Undetectable VL at 6 months Undetectable VL at 1 year Switch Viral load: Odds ratio (OR) 95% CI Odds ratio (OR) 95% CI <5 log PI/r regimen adherence: <90% Duration of virologic failure pre-switch : <180 days

11 Discussion The most important findings of our study are that a high level of viremia (>5 log 10 copies/ml) and prolonged time (>180 days) on a failing first-line NNRTI regimen significantly reduced the likelihood of achieving undetectable VL within the first year of PI/r-based second-line ART. Comparable to our median baseline VL of 4.6 log 10 copies/ml, Ferradini and colleagues 3 also reported a high median VL (4.7 log 10 copies/ml) at the time of switch to second-line ART.

12 Study limitations This is a retrospective analysis with a small sample size exclusive of second-line ART decedents and those lost to follow up. Drug resistance testing was not utilized in this study.

13 Conclusion We present preliminary evidence for a threshold application for first-line to second-line ART switch based on factors associated with early virologic suppression on protease inhibitor-based therapy in a Nigerian cohort. We recommend that provided drug adherence exceeding 90% is ascertained, patients should be promptly switched before : failing viremia exceeds 5 log 10 copies/ml, and within six months of confirmed virologic failure on first-line ART.

14 References National Agency for the Control of AIDS (NACA). Fact sheet 2011: ART in Nigeria. Available at: Accessed 4 th February, The joint United Nations Programme on HIV/AIDS (UNAIDS) 2007Aids epidemic update: Available at Accessed 18 th May, Ferradini L, Ouk V, Segeral O, et al. High efficacy of lopinavir/r-based second-line antiretroviral treatment after 24 months of follow up at ESTHER/Calmette Hospital in Phnom Penh, Cambodia. Journal of the International AIDS Society 2011;14:14 Pujades-Rodríguez M, O Brien D, Humblet P, et al. Second-line antiretroviral therapy in resource-limited settings: the experience of Médecins Sans Frontières. AIDS 2008, 2:

15 Acknowledgements We thank APIN-UCH patients and APIN Working Group; Prof. Phyllis Kanki and her Harvard School of Public Health team; the Division of Infectious Diseases, Feinberg School of Medicine, Northwestern University, Chicago; the NU-AITRP team of University College Hospital, Ibadan; the Centre for Global Health, Northwestern University, Chicago; Fogarty International Center of the NIH; and the Federal Ministry of Health, Nigeria. Support information: The project was supported by Award Number D43TW A1 from the Fogarty International Centre. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Fogarty International Centre of the National Institutes of Health.

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