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Substitution of Efavirenz or Nevirapine for Protease Inhibitor (80% "success")
Reported by Jules Levin
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A research group from France, Romania, and Portugal (abstract H-170) reported
results from following patients for 2 years after switching from a protease
inhibitor to a NNRTI. The study authors did not mention if the patients
changed their NRTIs. 139 patients were included in this study. 82 patients
switched to nevirapine and 57 to efavirenz. They looked retrospectively at
patients attended their clinics between June 1999 and June 2000. Viral load
had to be <400 copies/ml at the time of the switch. In assessing whether a
patient was a failure, the authors considered if the patient was still
continuing on their initial NNRTI, had viral failure (<1000 copies/ml), had
immunologic failure (that is, no opportunistic infection or significant
decrease in CD4: more than 50% from baseline), discontinued due to adverse
events, or discontinued for other reasons. Patients in both groups had been
<400 copies for on average 20 months; had been on HAART for on average 24
months. CD4 wee on average 520 in both groups. 32% of patients were on
AZT/3TC and 12% on d4T/ddI. Most were taking indinavir or nelfinavir. This
was the first switch for 40-49% of patients; 50-59% had more than 1 switch.
15% of patients were coinfected with HCV. Cholesterol & triglyceride levels
were about the same in both groups: Cholesterol was about 6 mmol/L (I think
this translates to 247 mg/dL cholesterol by US measures) and TGs about 2.30
mmol/L (202 mg/dL). ALT and AST were under 50 in both groups
RESULTS
After 2 years following the switch 80% of patients (ITT analysis) were
considered successful. Patients were considered a success if they remained on
the NNRTI switched to initially, viral load remained below <1000, and they
had no immunological failure (50% decrease in CD4 and no opportunistic
infection). 80% in both groups were considered successful in their switch,
this overall 80% rate was the same for both NVP and EFV. However the reasons
for failure were different. Viral failures were more frequent in the
nevirapine group; adverse events were more frequent in the efavirenz group,
the most frequent adverse event was neurologic, about 50% reported neurologic
reaction. Rash (8%) occurred more often in the nevirapine group. The authors
assessed metabolic changes and found partial improvements: nevirapine
patients appeared to have better improvement in triglycerides (p=0.045) and a
trend for better improvement in total cholesterol (p=0.18). But HDL (good
cholesterol) and LDL (bad cholesterol) was only available on 36% of patients
so this was not analyzed.
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