Failure of HAART in Baltimore
Source: Lucas GM, et al. Ann Intern Med 1999;131:81-87.
Near perfect adherence to the newer antiretroviral regimens is essential to an effective and durable virologic response. Whereas clinical trials data continue to suggest that the most effective regimens can suppress HIV viral loads in a majority of patients for up to 2-3 years, comparable results in unselected community-based patients appear more elusive. Changes in plasma viral loads were assessed in 273 protease-inhibitor (PI) naive patients attending the Johns Hopkins HIV Clinic in the heart of Baltimore who were beginning a PI-containing regimen. The selection of PI therapy was fairly balanced: 39% received indinavir, 34% nelfinavir, and 27% ritonavir. Sa-quinavir was additionally used in 1% of patients receiving indinavir, 11% receiving nelfinavir, and 68% receiving ritonavir.
Undetectable viral loads were observed in only 42% of patients at 1-90 days, 44% at 3-7 months, and 37% at 7-14 months. Only 23% experienced viral suppression during all three time periods. Missed visits, nonwhite ethnicity, injection drug use, lower CD4+ cell counts, and higher viral loads were each associated in univariate analysis with failure to suppress viral load. In multivariate analysis, however, the single most significant factor associated with failure was a history of missed clinic appointments. Adverse effects to medication were also a significant risk factor for drug failure by 7-14 months of therapy. Side effects to ritonavir (49%; most of which were gastrointestinal) were more than twice as frequent as those to either indinavir (21%) or nelfinavir (22%), although this may have, in part, been due to the more frequent use of dual PIs in this group. In addition, women experienced significantly more frequent side effects to medication than men (37% vs 25%; P = 0.008).
The implications of these data from an organization dedicated to providing HIV care to a large number of inner city subjects are potentially disastrous, with the resulting development of multi-drug-resistant virus in most of those who fail therapy. Lucas and associates suggest that special programs directed at specific hard-to-treat groups, with a focus on patients who frequently miss appointments, should be further explored. Delaying the initiation of therapy in patients who frequently miss appointments, especially those with earlier disease, may be a necessary and important first step. The identification of simplified regimens with better tolerance is next.
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