Nevirapine-raltegravir combination, a NRTI and PI/r sparing regimen, as maintenance antiretroviral therapy in virologically suppressed HIV-1-infected patients

Véronique Reliquet, Catherine Chirouze, Clotilde Allavena, Patrice Muret, Gilles Peytavin, Elisabeth André-Garnier, Dominique Bettinger, Virginie Ferré, Bruno Hoen, François Raffi
2013 Antiviral Therapy  
Nucleoside reverse transcriptase inhibitor (NRTI) and protease inhibitor (PI)/ritonavir sparing regimens may be useful to some HIV-infected patients. Nevirapine (NVP) and raltegravir (RAL) are both potent antiretrovirals with good long-term safety profiles. Methods: We retrospectively identified from our electronic database all patients with HIV RNA<50 copies/ml for >6 months on an NVP-containing regimen and no prior exposure to integrase strand transfer inhibitors who were switched to RAL plus
more » ... NVP. Data was collected for 36 months or until discontinuation of RAL plus NVP for any reason. Results: A total of 39 patients (30 male) were included in this analysis. Median duration of prior antiretroviral therapy was 14 years (IQR 10-17) and median duration with plasma HIV-1 RNA<50 copies/ml prior to switch was 50 months (IQR 22-96). Switched regimens included mainly a boosted PI (n=24) or tenofovir disoproxil fumarate/emtricitabine (n=12). After switching, the percentages of patients with HIV-1 RNA<50 copies/ml were 87.2% (95% CI 76.7, 97.7) and 82.1% (95% CI 70.0, 94.1) at 6 and 12 months, respectively, in the intent-to-treat-exposed analysis, 97.1% (95% CI 91.6, 100) and 94.1% (95% CI 86.2, 100), respectively, in the per-protocol analysis. All patients with follow-up to month 24 (n=22) or month 36 (n=14) had HIV-1 RNA<50 copies/ml. One virological failure was observed (related to archived non-nucleoside reverse transcriptase inhibitor resistance mutation). During follow-up, no patient experienced Grade 3 or 4 adverse events. Median values of serum creatinine and lipids significantly improved after switch. Conclusions: In patients with prolonged HIV-1 RNA<50 copies/ml, switching to NVP-RAL combination maintained virological suppression throughout 36 months. This combination deserves further evaluation in patients unable to tolerate NRTI or PI/ritonavir agents. Nucleoside reverse transcriptase inhibitor (NRTI)-and protease inhibitor (PI)-sparing antiretroviral regimens may be useful in patients faced with resistance or intolerance to these two classes of drugs. Among other classes, non-nucleoside reverse transcriptase inhibitors (NNRTIs) and integrase strand transfer inhibitors (INSTIs) have high potency. Nevirapine (NVP), a member of the NNRTI class, has a very good long-term safety profile [1]. Raltegravir (RAL), the first available INSTI, has also demonstrated good tolerability over 5 years [2] . Neither of these two antiretrovirals are associated with drug-limiting adverse events in the long-term, such as increased cardiovascular risk, lipid elevations, renal, bone or central nervous system toxicity. Furthermore, RAL is metabolized primarily via uridine diphosphate glucuronosyltransferase (UGT) 1A1, instead of cytochrome P-450 [3]; therefore, no clinically meaningful drug-to-drug interaction is expected between RAL and NVP. There is only limited data on the use of a dual combination of an NNRTI and an INSTI as a maintenance regimen in virologically suppressed Short communication Nevirapine-raltegravir combination, an NRTI and PI/r sparing regimen, as maintenance antiretroviral therapy in virologically suppressed HIV-1-infected patients
doi:10.3851/imp2691 pmid:24145365 fatcat:tpokwjq33nhtzaxf7pqfi2yqhe