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The Body Covers: The 45th Interscience Conference on Antimicrobial Agents and Chemotherapy

Severe Events Unrelated to AIDS or Antiretrovirals Were Most Common in Early HAART Patients

Coverage provided by Brian Conway, M.D., F.R.C.P.C.

December 16, 2005

As antiretroviral treatment evolves, the causes of morbidity in HIV-infected patients evolve with it. Over the past 20 years we have seen significant changes in what are the most common health complications among HIV-infected patients, particularly as AIDS-defining opportunistic infections gave way to other morbidities -- many of which cannot be directly attributed to antiretrovirals themselves.

The latest evidence of this trend comes from the French APROCO-COPILOTE study, which was conducted with 1,281 patients who started a protease inhibitor-based regimen between 1997 and 1999. Vincent Le Moing presented the five-year findings from this prospective cohort study at this conference.

Participants in APROCO-COPILOTE had a baseline CD4+ cell count of 275 copies/mm3 and a baseline HIV plasma viral load of 4.4 log10 copies/mL. Seventy-seven percent of the cohort was male, the median age was 37 years, 57% of the patients previously received antiretroviral therapy, and 25% were coinfected with hepatitis C. Researchers recorded incidence of death and "severe" events, defined as events that were grade 3 or 4, that were life threatening or that led to hospitalization.

Over five years of observation, there were 101 deaths (1.9 per 100 patient-years, or an overall risk of 10%), 120 cases of AIDS-defining illnesses (3.11 per 100 patient-years; overall risk 16%) and 1,107 other severe events, including 431 serious drug-related adverse events (8.3 per 100 patient-years; overall risk 30%). Serious adverse events other than AIDS-defining illnesses or serious drug-related adverse events were more common than other events, with an overall risk of 35%.

In terms of specific events, there was a relatively high incidence of five-fold elevation of transaminase levels (9.5%), as well as cardiovascular events (6%) and depression or suicide (3%). The single most common type of severe event unrelated to AIDS or antiretrovirals was bacterial infection (15%). The frequency of all events was highest in those with a CD4+ cell count below 50 cells/mm3.

In patients with more mild immune disease, serious events (excluding disease progression or death) were most frequent in those who were coinfected with hepatitis B or hepatitis C (42%) or who were injection drug users (34%).

These data may primarily be of historical interest, since they reflect the serious limitations and pitfalls of our first highly active antiretroviral therapy (HAART) regimens; after all, this study recruited patients who initiated therapy in the late 1990s.

Nonetheless, as we treat more injection drug users and individuals coinfected with viral hepatitis, study results such as these serve as a reminder that special care may be warranted to manage the side effects of therapy and other medical events that may occur after we initiate HAART. This may be the key to long-term treatment success among these patients.

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