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Sir, Despite the use of potent and less-toxic drugs, NRTI exposure is associated with increasing reports of toxicity. In the search of alternatives, boosted PI monotherapy is not as effective as triple therapy, with a lower rate of viral suppression and increased intermittent viraemia (blips). However, dual therapy with lamivudine plus a PI boosted with ritonavir has shown promising preliminary data and recently, lamivudine plus lopinavir/ritonavir twice daily has been shown to be non-inferior to triple therapy in naive patients. This fact prompted us to prospectively assess from January 2011 to July 2013 the efficacy of a dual regimen with the combination of lamivudine plus darunavir/ritonavir (300 mg plus 800/100 mg, once daily), used after toxicity was experienced with NRTIs. No cases of pregnancy or chronic hepatitis B virus infection were included. No patient had evidence of resistance to darunavir or lamivudine or a previous history of virological failure. The study was approved by our institutional review board (EC 182/11) and patients gave written informed consent to clinical and analytical follow-up. Routine physical examination and laboratory tests, including CD4+ cell counts and HIV-1 RNA levels [Versant HIV-1 RNA 1.0 Assay (kPCR), Siemens Diagnostics; limit of detection, 37 copies/mL], were performed at baseline and at every 3–4 months. The glomerular filtration rate (eGFR) was estimated at every analytical determination by the Chronic Kidney Disease Epidemiology Collaboration equation and urine analysis including measurements for protein, creatinine and glucose was performed at every visit. The primary study endpoint was the proportion of patients who were free of treatment failure during 48 weeks, defined as virological failure (HIV RNA level .37 copies/mL in two successive determinations), discontinuation of any drug or reintroduction of a three-drug regimen. Transient viral replication (blip) was defined as having an HIV RNA level .37 copies/mL not confirmed in a successive determination. At each timepoint, differences with respect to baseline were compared by the Wilcoxon rank test for paired samples. A twotailed P value of ,0.05 was considered statistically significant. Overall, 48 patients were included and had .48 weeks of follow-up. The mean age of the patients was 50 years and 65% were male. Of note, patients had an undetectable HIV RNA level for a median time of 42 months (IQR 11.3–62.8) and showed a median nadir CD4+ count of 220 cells/mm (IQR 101–312) and a median CD4+ count of 563 cells/mm (IQR 399–795) at inclusion. Also, the majority of patients (30 cases, 63%) discontinued tenofovir from the NRTI backbone (8 interrupted didanosine, 7 abacavir and 3 other), mainly due to renal issues (25, 83%). Strikingly, only 10patientswerereceivingdarunavirasthethirddrug:13werereceivingNNRTIs (3etravirine, 3nevirapineand7 efavirenz) and 25 received anotherPI (9atazanavir,11fosamprenavirand5lopinavir).Causesof switch varied widely according to the previous regimen. All of the patients but one reached the study endpoint and had an undetectable HIV RNA level at 48+4 weeks. Thus, the efficacy Research letters

Efficacy of dual therapy with lamivudine plus darunavir boosted with ritonavir once daily in HIV-infected patients with nucleoside analogue toxicity