Background:To assess the efficacy (viral load [VL]; CD4 count) and safety of a simpliflied regimen in subjects showing poor adherence to antiretroviral (ARV) treatment, assessed by a questionnaire designed to improve patients' involvement in therapeutic choices. Methods: Seventy out of 220 consecutive HIV+ adults, treated with Pi plus NRTI-based regimens for a median of 12 months before evaluation, answered a questionnaire with closed questions. In 25 out of 70 (median age: 31 yrs, range 23-46; 19 male, 6 female; 13 MSM, 5 hetero; 7 ex-IDUs; none unemployed), poor adherence to therapy was due to pill burden; treatment was switched to ZVD+3TC+ABV. Genotypic resistance was assessed at baseline; CD4 count, plasma HIV-1 RNA (B-DNA) and blood chemistry at baseline and monthly for 6 months, then every 3 months. Results:Genotypic tests showed no resistance to either NRTI or Pis (patients admitted treatment interruptions since at least 15 wks). During a 120 wks follow-up, 16 pts with baseline VL >50 copies/mL (mean 4.45 ± 0.34 log copies/mL) showed a decrease to < 50 copies/ml after switching and remained stable throughout the follow-up, while 7 with baseline VL <50 copies/ml maintained negative VL. Only 2 pts showed a viremia "blip"(VL< 450 copies/ml) at 72 and 80 wks after switching. Switch therapy led to a mean increase of 157± 42 CD4 cells/îl at the end of follow-up (p<0.01 by paired t-test) in the 16 pts with baseline VL >50 copies/mL, while no significant variation of CD4 cells was evident in pts with baseline VL <50 copies/mL, including the 2 pts with "blips". No haematological or liver toxicity was detected. Conclusions: Switching to a regimen of ZVD, 3TC and ABV appears to be safe and effective in pts with difficulties in maintaining adherence. This regimen was successful in achieving undetectable viral loads as well as a satisfactory immunological profile up to 120 wks, in patients whose poor adherence to ARV treatment was assessed by a specific questionnaire.
Lack of adherence to antiretrovirals caused by pill burden; efficacy and safety of simplification to a triple-nucleoside regimen (Trizivir)
BIGLINO, Alberto;
2004-01-01
Abstract
Background:To assess the efficacy (viral load [VL]; CD4 count) and safety of a simpliflied regimen in subjects showing poor adherence to antiretroviral (ARV) treatment, assessed by a questionnaire designed to improve patients' involvement in therapeutic choices. Methods: Seventy out of 220 consecutive HIV+ adults, treated with Pi plus NRTI-based regimens for a median of 12 months before evaluation, answered a questionnaire with closed questions. In 25 out of 70 (median age: 31 yrs, range 23-46; 19 male, 6 female; 13 MSM, 5 hetero; 7 ex-IDUs; none unemployed), poor adherence to therapy was due to pill burden; treatment was switched to ZVD+3TC+ABV. Genotypic resistance was assessed at baseline; CD4 count, plasma HIV-1 RNA (B-DNA) and blood chemistry at baseline and monthly for 6 months, then every 3 months. Results:Genotypic tests showed no resistance to either NRTI or Pis (patients admitted treatment interruptions since at least 15 wks). During a 120 wks follow-up, 16 pts with baseline VL >50 copies/mL (mean 4.45 ± 0.34 log copies/mL) showed a decrease to < 50 copies/ml after switching and remained stable throughout the follow-up, while 7 with baseline VL <50 copies/ml maintained negative VL. Only 2 pts showed a viremia "blip"(VL< 450 copies/ml) at 72 and 80 wks after switching. Switch therapy led to a mean increase of 157± 42 CD4 cells/îl at the end of follow-up (p<0.01 by paired t-test) in the 16 pts with baseline VL >50 copies/mL, while no significant variation of CD4 cells was evident in pts with baseline VL <50 copies/mL, including the 2 pts with "blips". No haematological or liver toxicity was detected. Conclusions: Switching to a regimen of ZVD, 3TC and ABV appears to be safe and effective in pts with difficulties in maintaining adherence. This regimen was successful in achieving undetectable viral loads as well as a satisfactory immunological profile up to 120 wks, in patients whose poor adherence to ARV treatment was assessed by a specific questionnaire.
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