Data from studies demonstrating potential models for the delivery of antiretroviral therapy (ART) have shown ART to be effective in resource-limited settings [1,2]. It is unclear whether these models can be generalized to other settings, as data on the use of ART in primary care, non-research settings are not available. This current study was designed to describe patients prescribed ART in a private primary care clinic in rural Kwazulu-Natal, South Africa. A retrospective chart review was undertaken in January and February 2002 to describe demographic variables, financing mechanisms, current drug usage patterns, adherence (as measured from drug prescription renewals) and effectiveness of therapy, as reflected by changes in the CD4 cell count and viral load. Seventy-two patients were prescribed ART through the clinic between March 1999 and the study period. Seventy out of the 72 patients (97.2%) were black and two were white (2.8%). Forty-two patients (58.3%) were women. The median age at diagnosis was 33 years (6 months to 55 years). Employment data was available for 43 patients: 26 out of 43 (60%) were teachers, 12 (28%) were skilled labourers and five (12%) were policemen. Fifty-four patients (75%) were tested for HIV after presenting with clinical signs of infection, six (8%) were tested because of contact (three patients), pregnancy (two patients) or for insurance (one patient). The reasons for testing were unknown in 12 cases. Tuberculosis (12 patients), lymphadenopathy (eight patients), weight loss (eight patients) and shingles (eight patients) were the most common presenting conditions. Twenty-five patients (44%) with charted reasons for testing presented with an AIDS-defining illness. The median haemoglobin level was 10.4 g/dl (range 6.6–15.7) in women and 12.8 g/dl (range 6.9–15.3) in men. The median CD4 cell count was 245 cells/mm3 (range 23–650) and the median viral load was 102 917 (range < 400 to > 750 000) copies/ml. (Table 1).Table 1: Patient characteristics at initial visit.Sixty-two patients (86%) had a medical aid scheme that covered ART, and 10 paid for their drugs out of pocket. In the medical aid group, insurers refused ART to seven patients because their CD4 cell count was greater than 350 cells/mm3. Eight patients were not started as their insurance had expired or no longer covered ART. Of the remaining 57 patients, 31 (55%) received triple therapy, 17 (30%) received double therapy, seven (12%) received a hydroxyurea-containing regimen, and two (3%) received single nucleoside therapy. The most commonly prescribed regimen was zidovudine, lamivudine and efavirenz (37%). No patients without medical aid received triple therapy. Adherence data were available for 36 patients and were based on the number of prescriptions filled. Eight patients (22%) were more than 90% adherent and 21 (58%) were less than 70% adherent. The reasons for non-adherence were rarely known, but included patients thinking that a month of therapy was sufficient, sharing with a spouse and medical aid funds being exhausted. Follow-up data were available for 37 patients (two on single therapy, eight on double therapy, six on hydroxyurea regimens, and 21 on triple therapy). Twelve patients (32%) achieved a viral load of leas than 400 copies/ml. The CD4 cell count at a mean of 217 days after initiation of therapy increased 70 cells/mm above baseline (P < 0.05). Haemoglobin levels were unchanged from the initial visit and no liver function abnormalities were noted in the 15 patients who were tested after the initiation of ART. This study describes the use of ART in a real life primary care setting in rural Africa, and reveals a number of barriers to effective ART in an area with relatively advanced infrastructure and monitoring. First, patients presented late in the course of their disease; almost half had CD4 cell counts of less than 200 cells/mm3. Second, only 55% received treatment that followed the World Health Organization (WHO) guidelines for resource-limiteited settings [3], no patients without insurance received recommended therapy. Third, adherence was poor when measured by prescription refill. The possible reasons suggested here include medical aid funds being exhausted for the year, poor patient education about ART, and a lack of provider training and expertise. Finally, the virological and immunological responses were suboptimal, which may be the result of inadequate combinations of antiretroviral drugs or poor adherence. Studies performed in centres with considerable support for providers and patients have shown that ART can be safe and effective in resource-limited settings [1,2]. Our study shows that when ART is introduced without adequate support for providers and patients the results can be disappointing. Discovering the reasons for success in these more controlled settings will be important. There is an immense need for operational research in antiretroviral delivery in resource-limited settings that not only advocates the use of these medications but describes ways to integrate them into existing private and public sector activities.
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Livesley et al. (2003) studied this question.