Safety and effectiveness of switching to Abacavir/Lamivudine plus rilpivirine for maintenance therapy in virologically suppressed HIV-1 individuals in Singapore (SEALS).

BACKGROUND: The efficacy and tolerability of an antiretroviral regimen are important considerations for selection of HIV-1 infection maintenance therapy. Abacavir/lamivudine plus rilpivirine (ABC/3TC + RPV) has been shown in international studies to be effective and well-tolerated in virologically suppressed individuals. This study evaluated the effectiveness and safety of switching to ABC/3TC + RPV as maintenance therapy in virologically suppressed HIV-1 infected individuals in Singapore. METHODS: In this retrospective, single-centre study, we included individuals who were prescribed ABC/3TC + RPV, had HIV-1 viral load (VL) < 50 copies/ml immediately pre-switch, and had no documented history of resistance mutations or virologic failure to any of the components. The follow-up period was 48 ± 12 weeks. The primary outcome was the proportion of individuals who maintained virologic suppression of HIV-1 VL < 50 copies/ml at the end of follow-up period based on on-treatment analysis. The secondary outcomes were the resistance profiles associated with virologic failure, changes in immunologic and metabolic parameters, and the safety profile of ABC/3TC + RPV. RESULTS: A total of 222 individuals were included in the study. The primary outcome was achieved in 197 individuals [88.8%, 95% confidence interval: 83.7-92.4%]. There were 21 individuals (9.5%) who discontinued treatment for non-virologic reasons. The remaining 4 individuals experienced virologic failure, of whom, 3 of these individuals had developed emergent antiretroviral resistance and had HIV-1 VL > 500 copies/ml at the end of the 48 ± 12 weeks follow-up period. The remaining individual experienced sustained low level viremia and subsequently achieved viral suppression without undergoing resistance testing. A total of 49 adverse events were observed in 31 out of 222 individuals (14.0%), which led to 13 individuals discontinuing therapy. Neuropsychiatric adverse events were most commonly observed (53.1%). A statistically significant increase in CD4 was observed (p < 0.01), with a median absolute change of 31 cells/uL (interquartile range: - 31.50 to 140.75). No significant changes in lipid profiles were detected. CONCLUSION: ABC/3TC + RPV is a safe and effective switch option for maintenance therapy in virologically suppressed HIV-1 individuals with in Singapore.

Comparison of methods for measuring free thyroxin in nonthyroidal illness.

Patients with severe nonthyroidal illness (NTI) often have decreased serum thyroxin (T4) concentrations and sometimes have decreased free T4 (FT4) and increased tumor necrosis factor-alpha (TNF-alpha) concentrations. We evaluated four commercial methods for measuring FT4 [Abbott IMx, Amersham Amerlex MAB, Nichols, and Diagnostic Products Corporation (DPC) RIA] and one method for TNF-alpha in 41 NTI patients, 24 euthyroid control subjects, and 10 hypothyroid patients. Free T4 index (FTI) was also measured by the Abbott IMx method. Euthyroid subjects results were in the stated normal ranges. NTI FT4 was subnormal in 2.4%, 61%, and 29% by the Nichols, DPC, and Amerlex methods, respectively. The DPC, Amersham Amerlex, and Abbott IMx methods gave significantly lower FT4 values for the NTI group than for the controls. There were good correlations between the various FT4 methods in the NTI group. FTI concentrations correlated well with FT4 for the euthyroid and hypothyroid groups but poorly for the NTI group. The Abbott IMx and Nichols RIA methods yield values in the hypothyroid range for only a small proportion of NTI patients.