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Prognostic Value of Virological and Immunological Responses After 6 Months of Antiretroviral Treatment in Adults With HIV-1 Infection in Sub-Saharan Africa

De Luca, Andrea MD*,†; Marazzi, Maria Cristina MD; Mancinelli, Sandro MD§; Ceffa, Susanna PhD; Doro Altan, Anna Maria MD§; Buonomo, Ersilia MD§; Prosperi, Felice Mattia Carlo PhD*,¶; Pedruzzi, Barbara MD*; Noorjehan, Abdul Majid MD#; Scarcella, Paola MD§; Liotta, Giuseppe MD§; Palombi, Leonardo PhD§

JAIDS Journal of Acquired Immune Deficiency Syndromes: March 1st, 2012 - Volume 59 - Issue 3 - p 236–244
doi: 10.1097/QAI.0b013e31824276e9
Clinical Science

Background: HIV RNA monitoring is not available in most antiretroviral treatment (ART) programs in sub-Saharan Africa; switch to second-line therapy is mostly guided by clinical/immunological criteria. This may lead to unnecessary disease progression and drug resistance accumulation. We investigated the prognostic value of virological and immunological status 6 months after ART initiation with respect to death, loss to follow-up, and treatment switch.

Methods: We considered treatment-naive HIV-1–infected patients, starting ART with available 6-month visit and subsequent follow-up, enrolled in a prospective cohort comprising 5 ART sites in 3 sub-Saharan countries. Outcome measures included the time from 6-month visit to death for all causes, loss to follow-up, and switch to second line.

Results: Of 2539 patients, 62% were females, their median pre-ART CD4 count was 215 cells per microliter, median HIV RNA 4.6 Log10 copies per milliliter, 30% were on WHO stage 3/4. At 6 months, 85% had HIV RNA <1000 copies per milliliter. During 3112 person-years follow-up after the 6-month visit, 91 patients died. Death was predicted by 6-month HIV RNA ≥10,000 copies per milliliter, adherence, and 6-month CD4 <200 cells per microliter. The 2-year estimated probability of surviving ranged from 0.69 (with 6-month HIV RNA ≥10,000 and CD4 <200) to 0.95 (with HIV RNA <1000 and CD4 ≥200). Loss to follow-up (1.95 per 100 person-years follow-up) was predicted by the 6-month HIV RNA >10,000 copies per milliliter and adherence but not by CD4. Switch to second line (6.94 per 100 person-years follow-up) was predicted by 6-month HIV RNA and CD4.

Conclusions: In patients starting ART in sub-Saharan Africa, 6-month HIV RNA independently predicts subsequent survival, retention to care, and switch to second-line therapy. This measure warrants further evaluation as specific time point monitoring option.

*Institute of Clinical Infectious Diseases, Catholic University, Rome, Italy

Infectious Diseases Unit, University Hospital of Siena, Siena, Italy

Libera Università Maria SS Assunta (LUMSA), Rome, Italy

§Department of Public Health, University Tor Vergata, Rome, Italy

DREAM Program—Community of Sant'Egidio, Rome, Italy

Department of Pathology, Immunology, and Laboratory Medicine, College of Medicine, Emerging Pathogens Institute, University of Florida, Gainesville, FL

#DREAM Program coordination, Maputo, and Machava Health Center, Mozambique.

Correspondence to: Andrea De Luca, MD, Malattie Infettive Universitarie, Azienda Ospedaliera Universitaria Senese, Viale M Bracci 16 – 53100, Siena, Italy (e-mail: deluca.andrea@fastwebnet.it).

Supported by Cariplo Foundation and Intesa San Paolo Bank, for the DREAM Program in Malawi, and CEI (Conferenza Episcopale Italiana) for the DREAM Program in Mozambique. Many other public and private organizations support DREAM and private citizens in many European countries.

Presented at the 16th Conference on Retroviruses and Opportunistic Infections, Montreal, Canada, February 8-11, 2009. Abstract #597.

Each individual author fully contributed to the preparation of this article: S.M., S.C, and A.M.D.A. obtained the original patient data set in Malawi and Mozambique. M.C.M., G.L. and A.M.N. obtained, plotted and analyzed all clinical parameters and participated in the data analysis. A.M.D.A, P.N., E.B. and P.S. coordinated all data collection efforts from DREAM health clinics in Mozambique and Malawi and performed preliminary data analysis. S.C. and S.M. were responsible for the performance of all laboratory studies and coordinated the laboratory data for the project. A.D.L., M.C.F.P., B.P., and L. P. performed the final data analysis and wrote the article. M.C.M. was responsible for supervision of health centre activities and data base coordination. L.P. is the Principal Investigator and the Scientific Director of the DREAM program who coordinated all research efforts for the present article.

Andrea De Luca had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Andrea De Luca received speakers honoraria, served as consultant or participated in advisory boards for GlaxoSmithKline, Gilead, Abbott Virology, Tibotec-Janssen, ViiV Healthcare, Siemens Diagnostics and Monogram Biosciences. All other authors: no conflicts to disclose.

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Received July 29, 2011

Accepted November 16, 2011

© 2012 Lippincott Williams & Wilkins, Inc.