Viability and effectiveness of large-scale HIV treatment initiatives in sub-Saharan Africa: experience from western Kenya

Objectives:To determine the clinical and immunological outcomes of a cohort of HIV-infected patients receiving antiretroviral therapy. Design:Retrospective study of prospectively collected data from consecutively enrolled adult HIV-infected patients in eight HIV clinics in western Kenya. Methods:CD4 cell counts, weight, mortality, loss to follow-up and adherence to antiretroviral therapy were collected for the 2059 HIV-positive non-pregnant adult patients treated with antiretroviral drugs between November 2001 and February 2005. Results:Median duration of follow-up after initiation of antiretroviral therapy was 40 weeks (95% confidence interval, 38–43); 111 patients (5.4%) were documented as deceased and 505 (24.5%) were lost to follow-up. Among 1766 (86%) evaluated for adherence to their antiretroviral regimen, 78% reported perfect adherence at every visit. Although patients with and without perfect adherence gained weight, patients with less than perfect adherence gained 1.04 kg less weight than those reporting perfect adherence (P = 0.059). CD4 cell counts increased by a mean of 109 cells/μl during the first 6 weeks of therapy and increased more slowly thereafter, resulting in overall CD4 cell count increases of 160, 225 and 297 cells/μl at 12, 24, and 36 months respectively. At 1 year, a mean increase of 170 cells/μl was seen among patients reporting perfect adherence compared with 123 cells/μl among those reporting some missed doses (P < 0.001). Conclusions:Antiretroviral treatment of adult Kenyans in this cohort resulted in significant and persistent clinical and immunological benefit. These findings document the viability and effectiveness of large-scale HIV treatment initiatives in resource-limited settings.

[1]  J. Montaner,et al.  A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study. , 1998, JAMA.

[2]  B. Gazzard,et al.  Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN Study , 2004, The Lancet.

[3]  M. Chesney,et al.  The consistency of adherence to antiretroviral therapy predicts biologic outcomes for human immunodeficiency virus-infected persons in clinical trials. , 2002, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[4]  P. Weidle,et al.  Assessment of a pilot antiretroviral drug therapy programme in Uganda: patients' response, survival, and drug resistance , 2002, The Lancet.

[5]  E. Carter,et al.  Addressing the educational void during the antiretroviral therapy rollout. , 2004, AIDS.

[6]  R. Steinbrook.  The AIDS epidemic in 2004. , 2004, The New England journal of medicine.

[7]  Rebecca Voelker,et al.  Conquering HIV and stigma in Kenya. , 2004, JAMA.

[8]  Caroline A Sabin,et al.  Factors influencing increases in CD4 cell counts of HIV-positive persons receiving long-term highly active antiretroviral therapy. , 2004, The Journal of infectious diseases.

[9]  J. Montaner,et al.  A randomized, double-blind trial comparing combinations of nevirapine, didanosine, and zidovudine for HIV-infected patients: the INCAS Trial. Italy, The Netherlands, Canada and Australia Study. , 1998, JAMA.

[10]  A. Gelfand,et al.  Hierarchical Bayes Models for the Progression of HIV Infection Using Longitudinal CD4 T-Cell Numbers , 1992 .

[11]  Susan Swindells,et al.  Adherence to Protease Inhibitor Therapy and Outcomes in Patients with HIV Infection , 2000, Annals of Internal Medicine.

[12]  J. Neaton,et al.  A comparative trial of didanosine or zalcitabine after treatment with zidovudine in patients with human immunodeficiency virus infection. The Terry Beirn Community Programs for Clinical Research on AIDS. , 1994, The New England journal of medicine.

[13]  William M. Tierney,et al.  An electronic medical record system for ambulatory care of HIV-infected patients in Kenya , 2005, Int. J. Medical Informatics.

[14]  M A Fischl,et al.  A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. , 1997, The New England journal of medicine.

[15]  A. Harries,et al.  Preventing antiretroviral anarchy in sub-Saharan Africa , 2001, The Lancet.

[16]  G. Maartens,et al.  Outcomes after two years of providing antiretroviral treatment in Khayelitsha, South Africa , 2004, AIDS.

[17]  William M. Tierney,et al.  Academic institutions linking access to treatment and prevention. Case study. , 2004 .

[18]  Gene D Morse,et al.  Comparison of four-drug regimens and pairs of sequential three-drug regimens as initial therapy for HIV-1 infection. , 2003, The New England journal of medicine.

[19]  J. Weeks.  AIDS epidemic. , 1992, The National medical journal of India.

[20]  AVANTI 2. Randomized, double-blind trial to evaluate the efficacy and safety of zidovudine plus lamivudine versus zidovudine plus lamivudine plus indinavir in HIV-infected antiretroviral-naive patients , 2000, AIDS (London).

[21]  J J Mamlin,et al.  Partnerships in international health. The Indiana University-Moi University experience. , 1995, Infectious disease clinics of North America.

[22]  D. Spiegelman,et al.  Understanding the role of HIV load in determining weight change in the era of highly active antiretroviral therapy. , 2005, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[23]  K. Tashima,et al.  Efavirenz plus zidovudine and lamivudine, efavirenz plus indinavir, and indinavir plus zidovudine and lamivudine in the treatment of HIV-1 infection in adults. Study 006 Team. , 1999, The New England journal of medicine.

[24]  S. Weiss,et al.  The AIDS epidemic. , 1985, The New England journal of medicine.

[25]  L. Kingsley,et al.  Weight loss prior to clinical AIDS as a predictor of survival. Multicenter AIDS Cohort Study Investigators. , 1995, Journal of acquired immune deficiency syndromes and human retrovirology : official publication of the International Retrovirology Association.

[26]  D. Bates,et al.  Mixed-Effects Models in S and S-PLUS , 2001 .

[27]  E. Delaporte,et al.  Access to antiretroviral drugs and AIDS management in Senegal , 2003, AIDS.

[28]  E. Delaporte,et al.  Long-Term Benefits of Highly Active Antiretroviral Therapy in Senegalese HIV-1-Infected Adults , 2005, Journal of acquired immune deficiency syndromes.

[29]  D S Stein,et al.  Within-subject variation in CD4 lymphocyte count in asymptomatic human immunodeficiency virus infection: implications for patient monitoring. , 1994, The Journal of infectious diseases.