Comparison of efavirenz and nevirapine in HIV-infected patients (NEEF Cohort)

Department of Dermatology, University of Heidelberg, Germany.
International Journal of STD & AIDS (Impact Factor: 1.05). 07/2005; 16(6):404-9. DOI: 10.1258/0956462054094060
Source: PubMed


The non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz (EFV) and nevirapine (NVP) taken in combination with nucleoside reverse transcriptase inhibitors (NRTIs) have both shown to be just as highly effective as protease inhibitors (PIs) in reducing viral load in patients infected with HIV. Our study compares the performance of these two NNRTIs with each other. This was a non-randomized, prospective, two-arm, multi-centre trial. We evaluated all patients with an EFV- or NVP-containing antiretroviral regimen. The primary endpoint was the difference in success rates defined as a viral load of </=50 copies/mL at week 48. chi(2)-tests were used for naïve and pretreated patients using intention-to-treat (ITT) and on-treatment analysis. As secondary endpoints, a viral load of </=500 copies/mL and CD4 count at week 48 for naïve patients were evaluated. A Cox regression was used to adjust for prespecified covariates. We included 662 patients (NVP 337, EFV 325). The difference in success rates in the ITT analysis was 4.5% ( -11.5%, 19.0%), P=0.578. Pretreated patients with a triple therapy show a difference of 10.1 (-0.3, 20.6), P=0.056. Non-significant results appeared for all secondary analyses. In this trial, no difference between EFV and NVP in combination with NRTI backbone therapy can be shown, regarding viral load. Further randomized studies are necessary to evaluate possible differences.

6 Reads

  • Revue de l'infirmière 06/2005;
  • [Show abstract] [Hide abstract]
    ABSTRACT: Efavirenz und Nevirapin zhlen zu den oft verwendeten Medikamenten bei HIV-Infektion. Wichtige Nebenwirkung dieser Substanzen sind Arzneimittelexantheme. In der vorliegenden Studie werden die Exantheme als hufigste Nebenwirkung beider Substanzen charakterisiert.In einer prospektiven nichtrandomisierten Multicenterstudie wurden 662 HIV-infizierte Patienten mit einer antiretroviralen Kombinationstherapie mit Efavirenz (n=325) oder Nevirapin (n=337) eingeschlossen. In dieser Studie wurden Hufigkeit und Dauer der Exantheme sowie Rezidivexantheme bei Reexposition erfasst.Insgesamt traten bei 4,5% (n=30) der Patienten Exantheme auf (Nevirapin: 2,4%, Efavirenz: 6,4%). Bei 4Patienten wurde die Therapie bei einem aufgetretenen Exanthem nach einer Einzelfallentscheidung fortgefhrt; bei 3Personen wurden die initial verwendeten Medikamente bei Reexposition toleriert.Bei Arzneimittelexanthemen unter Nevirapin- oder Efavirenztherapie kann bei fehlender Blasenbildung, Schleimhautbeteiligung oder systemischen Zeichen eine Therapiefortsetzung erwogen werden.Efavirenz and nevirapine are frequently used drugs in antiretroviral therapy. Rashes are common side effects of these drugs. In this study, we examined the characteristics of efavirenz- and nevirapine-associated rashes.This prospective nonrandomized multicenter study included 662 HIV-infected patients (efavirenz: 325, nevirapine: 337) to determine incidence, duration, cross-reactivity, and outcome upon reexposure.Of the treated patients, 4.5% (n=30) developed rashes (nevirapine: 2.4% and efavirenz: 6.4%). In four patients treatment was not interrupted. Three patients were reexposed to the initial drug without any side effects.Therapy with nevirapine or efavirenz does not have to be interrupted if rashes exhibit no blistering, mucosal manifestations, or systemic signs.
    Der Hautarzt 08/2005; 56(9):847-853. DOI:10.1007/s00105-005-0911-z · 0.56 Impact Factor
  • [Show abstract] [Hide abstract]
    ABSTRACT: The presence of human immunodeficiency virus (HIV) in the central nervous system (CNS) is associated with the development of HIV-1-associated dementia (HAD), a major cause of HIV-related mortality. To eradicate HIV in the CNS, anti-HIV drugs need to reach the brain and cerebrospinal fluid (CSF) in therapeutic concentrations. This involves passage through the blood-brain and blood-CSF barriers. Using a well established guinea pig in situ brain perfusion model, this study investigated whether nevirapine [6H-dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one,11-cyclopropyl-5,11-dihydro-4-methyl], a non-nucleoside reverse transcriptase inhibitor (NNRTI), could effectively accumulate in the CNS. [(3)H]Nevirapine was coperfused with [(14)C]mannitol (a vascular/paracellular permeability marker) through the carotid arteries for up to 30 min, and accumulation in the brain, CSF, and choroid plexus was measured. [(3)H]Nevirapine uptake into the cerebrum was greater than uptake of [(14)C]mannitol, indicating significant passage across the blood-brain barrier and accumulation into the brain (this was further confirmed with capillary depletion and high-performance liquid chromatography analyses). Likewise, [(3)H]nevirapine showed a great ability to cross the blood-CSF barrier and accumulate in the CSF, compared with [(14)C]mannitol. The CNS accumulation of [(3)H]nevirapine was unaffected by 100 muM nevirapine, suggesting that passage across the blood-brain barrier can occur by diffusion. Furthermore, coperfusion with 100 muM efavirenz [2H-3,1-benzoxazin-2-one, 6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-, (4S)-; another NNRTI] did not significantly alter CNS accumulation of [(3)H]nevirapine, indicating that the efficacy of nevirapine in the CNS would not be altered by the addition of this drug to a combination therapy. Together, these data indicate that this anti-HIV drug should be beneficial in the eradication of HIV within the CNS and the subsequent treatment of HAD.
    Journal of Pharmacology and Experimental Therapeutics 06/2006; 317(2):746-51. DOI:10.1124/jpet.105.098459 · 3.97 Impact Factor
Show more