Current hemoglobin levels are more predictive of disease progression than hemoglobin measured at baseline in patients receiving antiretroviral treatment for HIV type 1 infection

The role of hemoglobin levels as an independent prognostic marker of progression to AIDS and/or death in HIV-infected patients starting combination antiretroviral therapy (cART) was investigated. A total of 2579 patients from the EuroSIDA cohort with hemoglobin, CD4 cell count, and HIV RNA viral load measured 6 months prior to starting cART was included in the analyses. Anemia was defined as mild (<= 14 g/dl males, <= 12 g/dl females) and severe (<8 g/dl both genders). Poisson regression was used to determine factors related to clinical progression (new AIDS/death). Hemoglobin levels increased by a median of +0.48 g/dl (IQR -0.4 to +1.3) in the first year of cART. During 14,272 person years of follow-up (PYFU) there were 505 new AIDS/deaths. Of the patients 304 (11.8%) developed mild and 19 severe anemia (0.7%). In multivariate analysis baseline hemoglobin was significantly associated with progression to AIDS/death after starting cART with an IRR of 1.07 per 1 g/dl lower (95% CI 1.01-1.13; p = 0.023). When hemoglobin was fitted as a time-updated variable the IRR increased to 1.36 per 1 g/dl lower (95% CI 1.30-1.42; p < 0.001). Starting cART was associated with an increase in hemoglobin levels. Lower hemoglobin values, particularly the latest measured, were associated with an increased risk of disease progression

Hypersensitivity reactions, hepatotoxicity, and other discontinuations in persons receiving integrase strand transfer inhibitors:results from the EuroSIDA study

Background: Hypersensitivity reaction (HSR) and hepatotoxicity are rare, but potentially serious side-effects of antiretroviral use. Objective: To investigate discontinuations due to HSR, hepatotoxicity or other reasons among users of dolutegravir (DTG) vs. raltegravir (RAL) or elvitegravir (EVG) in the EuroSIDA cohort. Methods: We compared individuals ≥18 years and starting combination antiretroviral therapy (ART, ≥3 drugs) with DTG vs. RAL or EVG, with or without abacavir (ABC), between January 16, 2014 and January 23, 2019. Discontinuations due to serious adverse events (SAEs) were independently reviewed. Results: Altogether 4366 individuals started 5116 ART regimens including DTG, RAL, or EVG, contributing 9180 person-years of follow-up (PYFU), with median follow-up 1.6 (interquartile range 0.7–2.8) years per treatment episode. Of these, 3074 (60.1%) used DTG (1738 with ABC, 1336 without) and 2042 (39.9%) RAL or EVG (286 with ABC, 1756 without). 1261 (24.6%) INSTI episodes were discontinued, 649 of the DTG-containing regimens (discontinuation rate 115, 95% CI 106–124/1000 PYFU) and 612 RAL or EVG-containing regimens (173, CI 160–188/1000 PYFU). After independent review, there were five HSR discontinuations, two for DTG (one with and one without ABC, discontinuation rate 0.35, CI 0.04–1.28/1000 PYFU), and three for RAL or EVG without ABC (0.85, CI 0.18–2.48/1000 PYFU). There was one hepatotoxicity discontinuation on DTG with ABC (discontinuation rate 0.18, CI 0.00–0.99/1000 PYFU). Conclusion: During 5 years of observations in the EuroSIDA cohort independently reviewed discontinuations due to HSR or hepatotoxicity were very rare, indicating a low rate of SAEs