Quality of Life in Patients Treated with First-Line Antiretroviral Therapy Containing Nevirapine And/Or Efavirenz
Authors:   the 2NN study group, van Leth Frank , Conway Brian , Laplumé Hector , Martin Des , Fisher Martin , Jelaska Ante , Wit Ferdinand W , Lange Joep MA , Laplumé H , Lasala MB , Losso MH , Bogdanowicz E , Lattes R , Krolewiecki A , Zala C , Orcese C , Terlizzi S , Duran A , Ebensrteijn J , Bloch M , Russell O , Russell DB , Roth NR , Eu B , Austin D , Gowers A , Quan D , Demonty J , Peleman R , Vandercam B , Vogelaers D , van der Gucht B , van Wanzeele F , Moutschen MM , Badaro R , Grinsztejn B , Schechter M , Uip D , Netto EN , Coelho SS , Badaró F , Pilotto JH , Schubach A , Barros ML , Leite OHM , Kiffer CRV , Wunsch CT , Nunes D , Catalani A , de Cassia Alves Lira R , Dossin TJ , D'Alló de Oliveira MT , Martini S , Conway B , de Wet JJ , Montaner JSG , Murphy C , Woodfall B , Sestak P , Phillips P , Montessori V , Harris M , Tesiorowski A , Willoughby B , Voigt R , Farley J , Reynolds R , Devlaming S , Livrozet JM , Rozenbaum W , Sereni D , Valantin MA , Lascoux C , Milpied B , Brunet C , Billaud E , Huart A , Reliquet V , Charonnat MF , Sicot M , Esnault JL , Slama L , Staszewski S , Bickel M , Lazanas MK , Stavrianeas N , Mangafas N , Zagoreos I , Kourkounti S , Paparizos V , Botsi Ch , Clarke S , Brannigan E , Boyle N , Chiriani A , Leoncini F , Montella F , Francesco L , Ambu S , Farese A , Gargiulo M , Di Sora F , Lavria F , Folgori F , Beniowski M , Boron Kaczmarska A , Halota W , Prokopowicz D , Bander DB , Leszuzyszyn-Pynka MLP , Wnuk AW , Bakowska E , Pulik P , Flisiak R , Wiercinska-Drapalo A , Mularska E , Witor A , Antunes F , Sarmento RSE , Doroana M , Horta AA , Vasconcelos O , Andrews SM , Huisamen CB , Johnson D , Martin O , Bekker L-G , Maartens G , Wilson D , Visagie CJ , David NJ , Rattley M , Nettleship E , Martin DJ , Keyser V , Moraites TM , Moorhouse MA , Pitt JA , Orrell CJ , Bester C , Parboosing R , Moodley P , Gathiram V , Woolf D , Bernasconi E , Magenta L , Cardiello P , Kroon E , Ungsedhapand C , Fisher M , Wilkins EGL , Stockwell E , Day J , Daintith RS , Perry N , Timaeus C , Intosh-Roffet J Mc , Powell A , Youle M , Tyrer M , Madge S , Drinkwater A , Cuthbertson Z , Carroll A , Becker S , Katner H , Rimland D , Saag MS , Thompson M , Witt M , Aguilar MM , LaVoy A , Illeman M , Guerrero M , Gatell J , Belsey E , Hirschel B , Potarca A , Cronenberg M , Kreekel L , Meester R , Khodabaks J , Botma H-J , Esrhir N , Farida I , Feenstra M , Jansen K , Klotz A , Mulder M , Ruiter G , Bass CB , Pluymers E , de Vlegelaer E , Leeneman (VCL) R , Carlier H , van Steenberge E , Hall D 
Published: April 2022

Objective To assess whether differences in safety profiles between nevirapine (NVP) and efavirenz (EFV), as observed in the 2NN study, translated into differences in ‘health related quality of life’ (HRQoL). Design A sub-study of the 2NN study, with antiretro-viral-naive patients randomly allocated to NVP (once or twice daily), EFV or NVP+EFV, in addition to stavudine and lamivudine. Methods Comparing differences in changes of HRQoL over 48 weeks as measured with the Medical Outcomes Study HIV Health Survey (MOS-HIV) questionnaire, using analysis of variance. Results The 2NN study enrolled 1216 patients. No validated questionnaires were available for 244 patients, and 55 patients had no HRQoL data at all, leaving 917 patients eligible for this sub-study. A total of 471 (51%) had HRQoL measurements both at baseline and week 48. The majority (69%) of patients without HRQoL measurements did, however, complete the study. The change in the physical health score (PHS) was 3.9 for NVP, 3.4 for EFV and 2.4 for NVP+EFV ( P=0.712). For the mental health score (MHS) these values were 6.1, 7.0 and 3.9, respectively ( P=0.098). A baseline plasma HIV-1 RNA concentration (pVL) ≥100 000 copies/ml and a decline in pVL (per log10) were independently associated with an increase of PHS. An increase of MHS was only associated with pVL decline. Patients experiencing an adverse event during follow-up had a comparable change in PHS but a significantly smaller change in MHS, compared with those without an adverse event. Conclusions First-line ART containing NVP and/or EFV leads to an improvement in HRQoL. The gain in HRQoL was similar for NVP and EFV, but slightly lower for the combination of these drugs.