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.