Elsevier

The Lancet

Volume 360, Issue 9326, 6 July 2002, Pages 34-40
The Lancet

Articles
Assessment of a pilot antiretroviral drug therapy programme in Uganda: patients' response, survival, and drug resistance

https://doi.org/10.1016/S0140-6736(02)09330-3Get rights and content

Summary

Background

Little is known about how to implement antiretroviral treatment programmes in resource-limited countries. We assessed the UNAIDS/Uganda Ministry of Health HIV Drug Access Initiative—one of the first pilot antiretroviral programmes in Africa—in which patients paid for their medications at negotiated reduced prices.

Methods

We assessed patients' clinical and laboratory information from August, 1998, to July, 2000, from three of the five accredited treatment centres in Uganda, and tested a subset of specimens for phenotypic drug resistance.

Findings

912 patients presented for care at five treatment centres. We assessed the care of 476 patients at three centres, of whom 399 started antiretroviral therapy. 204 (51%) received highly active antiretroviral therapy (HAART), 189 (47%) dual nucleoside reverse transcriptase inhibitors (2NRTI), and six (2%) NRTI monotherapy. Median baseline CD4 cell counts were 73 cells/μL (IQR 15–187); viral load was 193 817 copies/mL (37 013–651 716). The probability of remaining alive and in care was 0·63 (95% CI 0·58–0·67) at 6 months and 0·49 (0·43–0·55) at 1 year. Patients receiving HAART had greater virological responses than those receiving 2NRTI. Cox's proportional hazards models adjusted for viral load and regimen showed that a CD4 cell count of less than 50 cells/μL (vs 50 cells/μL or more) was strongly associated with death (hazard ratio 2·93 [1·51–5·68], p=0·001). Among 82 patients with a viral load of more than 1000 copies/mL more than 90 days into therapy, phenotypic resistance to NRTIs was found for 47 (57%): 29 of 37 (78%) who never received HAART versus 18 of 45 (40%) who received HAART (p=0·0005).

Interpretation

This pilot programme successfully expanded access to antiretroviral drugs in Uganda. Identification and treatment of patients earlier in the course of their illness and increased use of HAART could improve probability of survival and decrease drug resistance.

Introduction

Intolerance of the global inequities in AIDS care continues to grow. However, little information is available to guide development and implementation of antiretroviral drug programmes in developing countries. The use of antiretroviral therapy is expected to increase in resource-limited settings as drug prices fall and international agencies increase funding for AIDS programmes.1, 2, 3 At the same time, major challenges exist in the development of infrastructure needed to ensure uninterrupted drug stocks and the appropriate, safe, and effective use of these drugs.4, 5, 6, 7 The UNAIDS HIV Drug Access Initiative (DAI) was a pilot programme developed in 1997 to increase access to AIDS care and drugs in Uganda, Côte d'Ivoire, Chile, and Vietnam.2 The UNAIDS/Uganda Ministry of Health DAI pilot project, one of the first antiretroviral programmes in Africa, began in June 1998.

UNAIDS and the government of Uganda developed terms of agreement for the DAI, which included hiring a project coordinator and establishing an advisory board within the Uganda Ministry of Health. The advisory board conducted general oversight and policy development for the DAI. The initiative established national treatment guidelines, developed information materials, and trained and educated health-care providers on AIDS care. Patients and their families were responsible for paying for all their medical care, drugs, and laboratory tests. The US Centers for Disease Control and Prevention (CDC), in collaboration with the Ministry of Health and UNAIDS, assessed the virological and immunological response to treatment, sustainability of treatment, survival, and emergence of drug resistance among patients using the DAI. We present the results here.

Section snippets

Background

Five health-care facilities were accredited to provide antiretroviral drug treatment through the initiative; all were in or near the capital city of Kampala. Accreditation standards included having trained medical staff, a laboratory, counselling services, secure drug storage, and sufficient resources for the purchase of the first instalment of drugs. The experience and capacity of the participating centres varied greatly, although all represented the highest level of medical care available in

Patients and treatment regimens

912 patients were enrolled in the DAI at the five centres. This analysis included the 476 individuals who enrolled in the DAI at three centres evaluated: Nsambya Hospital (n=286), Mildmay HIV Care and Rehabilitation Center (n=157), and Mulago Hospital (n=33; table 1). Not included in this analysis were 424 patients started at JCRC and 12 at Mengo Hospital. For comparison, baseline characteristics of patients at JCRC were similar to those in this analysis with regard to age (median 37, p=0·3),

Discussion

This report summarises a systematic assessment of one of the first national programmes aimed at increasing access to antiretroviral therapy in Africa. This pilot programme showed that, through modest increases of existing resources, an effective system for drug procurement, distribution, and accountability could be implemented and maintained. This accomplishment led to an uninterrupted supply of drugs that supported sustainable management of patients, despite the often stated financial,

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