OBJECTIVE: To explore relationships between exposure to nevirapine and the virological response in HIV-1-infected individuals participating in the INCAS trial. METHODS: The elimination rate constant of plasma HIV-1 RNA (k) was calculated during the first 2 weeks of treatment with nevirapine, zidovudine and didanosine in 51 antiretroviral-naive HIV-1-infected patients. The relationships between the value of k, the time to reach an undetectable HIV-1 RNA concentration in plasma (< 20 copies/ml) and the success of therapy after 52 weeks of treatment as dependent variables and the exposure to nevirapine, baseline HIV-1 RNA and baseline CD4 cell count as independent variables, were explored using linear regression analyses, proportional hazard models and logistic analyses, respectively. RESULTS: The value of k for HIV-1 RNA in plasma was positively and significantly associated with the mean plasma nevirapine concentration during the first 2 weeks of therapy (P = 0.011) and the baseline HIV-1 RNA (P = 0.008). Patients with a higher exposure to nevirapine reached undetectable levels of HIV-1 RNA in plasma more rapidly (P = 0.03). From 12 weeks on, the median nevirapine plasma concentration was significantly correlated with success of therapy after 52 weeks (P < 0.02). CONCLUSIONS: A high exposure to nevirapine (in a twice daily regimen) is significantly associated with improved virological response in the short as well as in the long term. These findings suggest that optimization of nevirapine concentration might be used as a tool to improve virological outcome in (antiretroviral-naive) patients treated with nevirapine.
RCT Entities:
OBJECTIVE: To explore relationships between exposure to nevirapine and the virological response in HIV-1-infected individuals participating in the INCAS trial. METHODS: The elimination rate constant of plasma HIV-1 RNA (k) was calculated during the first 2 weeks of treatment with nevirapine, zidovudine and didanosine in 51 antiretroviral-naive HIV-1-infectedpatients. The relationships between the value of k, the time to reach an undetectable HIV-1 RNA concentration in plasma (< 20 copies/ml) and the success of therapy after 52 weeks of treatment as dependent variables and the exposure to nevirapine, baseline HIV-1 RNA and baseline CD4 cell count as independent variables, were explored using linear regression analyses, proportional hazard models and logistic analyses, respectively. RESULTS: The value of k for HIV-1 RNA in plasma was positively and significantly associated with the mean plasma nevirapine concentration during the first 2 weeks of therapy (P = 0.011) and the baseline HIV-1 RNA (P = 0.008). Patients with a higher exposure to nevirapine reached undetectable levels of HIV-1 RNA in plasma more rapidly (P = 0.03). From 12 weeks on, the median nevirapine plasma concentration was significantly correlated with success of therapy after 52 weeks (P < 0.02). CONCLUSIONS: A high exposure to nevirapine (in a twice daily regimen) is significantly associated with improved virological response in the short as well as in the long term. These findings suggest that optimization of nevirapine concentration might be used as a tool to improve virological outcome in (antiretroviral-naive) patients treated with nevirapine.
Authors: Rieneke M E van Praag; Elisabeth C M van Weert; Rolf P G van Heeswijk; Xiao-Jian Zhou; Jean-Pierre Sommadossi; Suzanne Jurriaans; Joep M A Lange; Richard M W Hoetelmans; Jan M Prins Journal: Antimicrob Agents Chemother Date: 2002-03 Impact factor: 5.191
Authors: Monique M R de Maat; G Corine Ekhart; Alwin D R Huitema; Cornelis H W Koks; Jan W Mulder; Jos H Beijnen Journal: Clin Pharmacokinet Date: 2003 Impact factor: 6.447
Authors: D González de Requena; S Bonora; S Garazzino; M Sciandra; A D'Avolio; R Raiteri; R Marrone; M Boffito; F G De Rosa; A Sinicco; G Di Perri Journal: Antimicrob Agents Chemother Date: 2005-09 Impact factor: 5.191
Authors: José Moltó; Asunción Blanco; Cristina Miranda; José Miranda; Jordi Puig; Marta Valle; Meritxell Delavarga; Carmina R Fumaz; Manuel José Barbanoj; Bonaventura Clotet Journal: Br J Clin Pharmacol Date: 2007-01-12 Impact factor: 4.335
Authors: Julius O Soyinka; Cyprian O Onyeji; Sharon I Omoruyi; Adegbenga R Owolabi; Pullela V Sarma; James M Cook Journal: J Pharm Pharmacol Date: 2009-04 Impact factor: 3.765
Authors: Lawrence Mbuagbaw; Sara Mursleen; James H Irlam; Alicen B Spaulding; George W Rutherford; Nandi Siegfried Journal: Cochrane Database Syst Rev Date: 2016-12-10