title: Short communication: lamivudine plus a boosted-protease inhibitor as simplification strategy in HIV-infected patients: proof of concept.
abstract: There are scarce data about the use of a dual therapy with lamivudine plus a ritonavir-boosted protease inhibitor (PI/r) as simplification strategy. We performed a retrospective cohort study of 44 HIV-infected patients on suppressive triple therapy PI/r-based HAART, HBV negative, who discontinued one nucleoside analogue (NA) due to toxicity, and continued dual therapy with lamivudine plus the PI/r. The median time of HIV infection was 18.6 years, and CD4(+) count nadir was 150 cells/μl (6-470). They had received a mean of four regimens before (2-20), and 55% had a previous AIDS diagnosis. In eight cases, a previous resistance test showed two to seven secondary mutations in the protease gene, without resistance to the PI/r. The 184V mutation was not observed, but previous failure with a lamivudine-including regimen had been observed in four patients (9%). At baseline, patients had viral suppression (<50 copies/ml) for a median time of 794 days (235-2344), while receiving atazanavir/r in five cases, lopinavir/r in 14, and darunavir/r in 25. They discontinued mainly tenofovir (19, 43%) and didanosine (15, 34%). During 101.5 patient-years of follow-up, only two patients failed (5%), because of incomplete adherence. CD4(+) count increase at 48 weeks was 55 cells/μl. No new adverse events were observed, although total cholesterol and triglycerides increased significantly during the first 6 months after simplification. In conclusion, dual therapy with lamivudine plus a boosted PI was safe and effective as simplification strategy in patients with toxicity to NA. This combination could be an alternative to mono or triple therapy in hard-to-treat patients.
authors.affiliation: Department of Infectious Diseases, Ramon y Cajal Hospital, Madrid, Spain. jcasado.hrc@salud.madrid.org
authors.forename: José L
authors.initials: JL
authors.lastname: Casado
authors.forename: Cristina
authors.initials: C
authors.lastname: de la Calle
authors.forename: María
authors.initials: M
authors.lastname: del Palacio
authors.forename: María J
authors.initials: MJ
authors.lastname: Perez-Elías
authors.forename: Ana
authors.initials: A
authors.lastname: Moreno
authors.forename: Santiago
authors.initials: S
authors.lastname: Moreno
mesh_terms: D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D023241:Antiretroviral Therapy, Highly Active / Q000009:adverse effects / Q000379:methods*; D015331:Cohort Studies; D024882:Drug Resistance, Viral; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020125:Mutation, Missense; D012189:Retrospective Studies; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D019380:Anti-HIV Agents; D017320:HIV Protease Inhibitors; D019259:Lamivudine