Week 96 efficacy and safety of darunavir/ritonavir monotherapy vs. darunavir/ritonavir with two nucleoside reverse transcriptase inhibitors in the PROTEA trial.

OBJECTIVES: PROTEA is a randomized controlled trial to assess the efficacy and safety of darunavir/ritonavir (DRV/r) monotherapy as an alternative to triple therapy. METHODS: Patients fully suppressed on first-line antiretrovirals (viral load < 50 HIV-1 RNA copies/mL) were switched to DRV/r 800/100 mg once daily, either as monotherapy (n = 137) or with two nucleoside reverse transcriptase inhibitors (NRTIs) (n = 136). Treatment failure was HIV-1 RNA level ≥ 50 copies/mL at week 96 or discontinuation of study treatment [Food and Drug Administration (FDA) snapshot algorithm]. RESULTS: Patients were mainly male and white, with mean age 44 years. In the primary efficacy analysis, the percentage of patients with HIV-1 RNA < 50 copies/mL by week 96 [intent to treat (ITT)] was lower in the DRV/r monotherapy arm (103 of 137 patients; 75%) than in the triple therapy arm (116 of 136 patients; 85%) [difference -10.1%; 95% confidence interval (CI) -19.5, -0.7%]. In the switch-included analysis, monotherapy was noninferior to triple therapy. In a post hoc analysis, for patients with nadir CD4 count ≥ 200 cells/µL, rates of HIV-1 RNA suppression were 82 of 96 patients (85%) in the DRV/r monotherapy arm and 88 of 106 patients (83%) in the triple therapy arm. No treatment-emergent primary protease inhibitor mutations were detected in either arm. The frequency of adverse events was similar in the two arms; however, one patient in the monotherapy arm was hospitalized with HIV encephalitis and elevated cerebrospinal fluid HIV-1 RNA. CONCLUSIONS: In this study, in patients with HIV-1 RNA < 50 copies/mL at baseline, switching to DRV/r monotherapy showed lower efficacy vs. triple therapy at week 96 in the primary ITT switch-equals-failure analysis, particularly in patients with CD4 counts < 200 cells/µL.

[Mycobacterium gordonae infections in human immunodeficiency virus infection]. / Infections à Mycobacterium gordonae au cours de l'infection par le virus de l'immunodéficience humaine.

OBJECTIVES: Non-tuberculous mycobacteria infections are frequent in patients infected with the human immunodeficiency virus (HIV). Mycobacterium avium intracellulare is the most frequent organism isolated but several other mycobacteria are also seen. Mycobacterium gordonae is a saprophytic mycobacteria which is rarely pathogenic. It was observed in 9% (7 patients) of the mycobacterial infections observed in our unit over a period of 3 years. METHODS: In order to determine whether M. gordonae plays a pathogenic role in HIV-infected patients, we re-evaluated the 7 clinical files of patients with M. gordonae infection. The findings were compared with data in the literature. RESULTS: All seven of our patients had a poor general health status with fever and pulmonary infection. The chest X-ray was abnormal in 5 patients. M. gordonae was isolated from blood cultures in 2 patients and from sputum or gastric contents in 5. Outcome was favourable using anti-tuberculosis combinations. CONCLUSION: A pathogenic role for M. gordonae cannot be excluded in HIV-infected patients. However, since this mycobacterium is an ubiquitous organism, diagnosis should be based on a typical clinical presentation and certain laboratory identification from appropriate samples.