title: Evaluation of the safety and effectiveness of nevirapine plus coformulated tenofovir/emtricitabine as first-line therapy in routine clinical practice.
abstract: Despite having demonstrated noninferior efficacy against atazanavir/ritonavir plus coformulated tenofovir/emtricitabine (cTDF/FTC), the combination of nevirapine plus cTDF/FTC is not included among preferred regimens in some international guidelines. This combination is frequently used in Spain. We analyzed its effectiveness and safety as first-line therapy in a routine clinical practice. A retrospective, multicenter study was performed in treatment-naive HIV-1-infected subjects who started nevirapine plus cTDF/FTC as first-line therapy according to the nevirapine CD4(+) cell count threshold. The primary endpoint was the proportion of subjects with plasma HIV-1 RNA <50 copies/ml at week 48. We included 123 subjects starting the regimen from 2005 to 2008. The median age was 41.0 years, the median baseline CD4(+) cell count was 215 cells/μl, the median plasma viral load (VL) was 4.83 log(10) copies/ml, and 22% had hepatitis C coinfection. At week 48, 96 subjects (78%; 95% CI: 69.9-84.4) had a VL <50 copies/ml in an ITT analysis, and the median rise in the CD4(+) cell count was 118 cells/μl. Virological failure was observed in 6.5% (8/123) of subjects, all them before week 24 and related to poor adherence. There was no relationship between virological failure and baseline CD4(+) cell count or VL. Ten percent (13/123) of the subjects discontinued the treatment due to adverse events. There was a significant decrease in total/HDL-cholesterol ratio (p=0.03) with an increase in HDL-cholesterol (p=0.01) over 48 weeks. The combination of nevirapine plus cTDF/FTC showed a high virological efficacy without unexpected toxicities as a first-line treatment in a routine clinical practice.
authors.affiliation: Department of Internal Medicine, Hospital del Mar, Barcelona, Spain. 91773@parcdesalutmar.cat
authors.forename: Gabriel
authors.initials: G
authors.lastname: Vallecillo
authors.forename: Pere
authors.initials: P
authors.lastname: Domingo
authors.forename: Josep
authors.initials: J
authors.lastname: Mallolas
authors.forename: Jesús
authors.initials: J
authors.lastname: Blanch
authors.forename: Elena
authors.initials: E
authors.lastname: Ferrer
authors.forename: Manuel
authors.initials: M
authors.lastname: Cervantes
authors.forename: Enric
authors.initials: E
authors.lastname: Pedrol
authors.forename: Hernando
authors.initials: H
authors.lastname: Knobel
authors.forename: Josep M
authors.initials: JM
authors.lastname: Llibre
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000453:epidemiology; D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000494:pharmacology*; D018791:CD4 Lymphocyte Count; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D000068679:Emtricitabine; D005260:Female; D017320:HIV Protease Inhibitors / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D019829:Nevirapine / Q000009:adverse effects / Q000494:pharmacology*; D063065:Organophosphonates / Q000009:adverse effects / Q000494:pharmacology*; D012367:RNA, Viral / Q000187:drug effects; D013030:Spain / Q000453:epidemiology; D000068698:Tenofovir; D019562:Viral Load / Q000187:drug effects
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D017320:HIV Protease Inhibitors; D063065:Organophosphonates; D012367:RNA, Viral; D003841:Deoxycytidine; D019829:Nevirapine; D000068698:Tenofovir; D000068679:Emtricitabine; D000225:Adenine