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Switch from PI to Nevirapine: 3 yr follow-up, lipids, viral load
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Efficacy and Safety of Protease Inhibitor (PI) Switching to Nevirapine (NVP) in HIV Patients with Undetectable Viral Load: Results after 3 Years
Reported by Jules Levin
Gil et al, Madrid, Spain. ICAAC poster H-846. ICAAC Sept 14-17, Chicago, 2003.
This study from Spanish researchers report on 143 patients who were PI therapy and switched to a nevirapine based regimen. The study is observational, longitudinal, and prospective and reports safety and viral responses 3 years after the switch. After 3 years following the switch 67% of patients retained viral suppression (<200 copies/ml, ITT) after 3 years on nevirapine based regimen. The study also showed improvements in lipids..
17% of the patients are HCV/HIV co-infected, and 70% were treatment-naïve prior to the PI regimen from which they switched. Average CD4 count was 600 at the time of switching. The reasons for switch by patients were to simplify treatment, hypercholesterolemia, hypertryglyceridemia, and renal impairment. Patients has <200 copies/ml HIV viral load for at least 3 months prior to switching.
The efficacy of the treatment for maintaining undetectable viral load (less than 200 copies/mL) in the first, second and third years were 79%, 74% and 67% using an intention to treat analysis (missing = failure).
9 patients had a viral rebound: four in the first year, two in the second year and three in the third year. Sixteen patients stopped nevirapine due to side-effects: rash (n=7 all of which occurred in the first 15 days); clinical hepatitis (n=2); transaminase elevations (n=5) and methadone interaction (n=2). All but two of the side-effects occurred in the first year after the switch. The liver toxicity was associated with patients who were co-infected with hepatitis C and two subjects developed hepatitis A.
CD4 counts increased about 100 over 3 years: mean CD4 cell count increased by 8.7%, 12.6% and 17.7%in years one, two and three, respectively.
The percent reduction of total cholesterol and triglycerides in years one, two and three as 21%, 20%, 19% and 71%, 69%, 72%, respectively. The reason for the high percent of reductions in triglycerides appeared to be because fasting lipid testing was conducted on a small number of patients. Many of the patients had TG levels greater than 1,000 mg/dl, decreasing to 330 mg/dl after switching to nevirapine. 28 patients who had fasting lipids had total cholesterol more than 240 mg/dl at baseline and 18 patients with triglycerides more than 400 mg/dL at baseline which were used for the lipid analysis. However, from a number of studies we know that nevirapine usually has a signifucantly beneficial effect on cholesterol and triglycerides.
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