Efficacy, Safety, and Durability of Long-Acting Cabotegravir and Rilpivirine in Adults With Human Immunodeficiency Virus Type 1 Infection: 5-Year Results From the LATTE-2 Study.

BACKGROUND: In the Long-Acting Antiretroviral Treatment Enabling Trial 2 (LATTE-2) phase 2b study, long-acting (LA) injectable cabotegravir + rilpivirine dosed every 8 weeks (Q8W) or every 4 weeks (Q4W) demonstrated comparable efficacy with daily oral antiretroviral therapy (ART) through 96 weeks in ART-naive adults with human immunodeficiency virus type 1 (HIV-1). Here we report efficacy, tolerability, and safety of cabotegravir + rilpivirine LA over approximately 5 years. METHODS: After 20 weeks of oral cabotegravir + abacavir/lamivudine, participants were randomized to cabotegravir + rilpivirine LA Q8W or Q4W or continue oral ART through the 96-week maintenance period. In the extension period through week 256, participants continued their current LA regimen (randomized Q8W/Q4W groups) or switched from oral ART to Q8W or Q4W LA therapy (extension-switch groups). Endpoints assessed included proportion of participants with HIV-1 RNA <50 copies/mL (Snapshot algorithm) and adverse events (AEs). RESULTS: At week 256, 186 of 230 (81%) participants in randomized Q8W/Q4W groups and 41 of 44 (93%) participants in extension-switch groups had HIV-1 RNA <50 copies/mL. No protocol-defined virologic failures occurred after week 48. Injection wsite reactions infrequently resulted in discontinuation (4 [2%] and 1 [2%] participants in randomized Q8W/Q4W and extension-switch groups, respectively). Three participants in randomized Q8W/Q4W groups experienced drug-related serious AEs, including 1 fatal serious AE (Q4W group); none occurred in extension-switch groups. Of 25 participants with AEs leading to withdrawal, 20 were in the randomized Q4W group; no AE leading to withdrawal occurred in >1 participant. CONCLUSIONS: Cabotegravir + rilpivirine LA exhibited long-term efficacy and tolerability, demonstrating its durability as maintenance therapy for HIV-1 infection.Clinical Trials Registration. NCT02120352.

A comparison of 3 metrics to identify health care-associated infections.

BACKGROUND: The best approach to measurement of health care-associated infection rates is controversial. METHODS: We compared 3 metrics to identify catheter-associated bloodstream infection (CA-BSI), catheter-associated urinary tract infection (CA-UTI), and ventilator-associated pneumonia (VAP) in 8 intensive care units during 2009. We evaluated traditional surveillance using National Healthcare Safety Network methodology, data mining with MedMined Data Mining Surveillance (CareFusion Corporation, San Diego, CA), and administrative coding with ICD-9-CM. RESULTS: A total of 65 CA-BSI, 28 CA-UTI, and 48 VAP was identified. Traditional surveillance detected 58 CA-BSI and no false positives; data mining identified 51 cases but 51 false positives; administrative coding documented 6 cases and 6 false positives. Traditional surveillance detected 27 CA-UTI and no false positives; data mining identified 17 cases but 19 false positives; administrative coding documented 3 cases and 1 false-positive. Traditional surveillance detected 41 VAP and no false positives; data mining identified 26 cases but also 79 false positives; administrative coding found 17 cases and 13 false positives. Overall sensitivities were as follows: traditional surveillance, 0.84; data mining, 0.67; administrative coding, 0.18. Positive predictive values were as follows: traditional surveillance, 1.0; data mining, 0.39; administrative coding, 0.57. CONCLUSION: Traditional surveillance proved superior in terms of sensitivity, positive predictive value, and rate estimation.