The Effect of Interrupted/Deferred Antiretroviral Therapy on Disease Risk: A SMART and START Combined Analysis.

Background: Pooled data from the SMART and START trials were used to compare deferred/intermittent versus immediate/continuous antiretroviral therapy (ART) on disease risk. Methods: Endpoints assessed were AIDS, serious non-AIDS (SNA), cardiovascular disease (CVD), cancer, and death. Pooled (stratified by study) hazard ratios (HRs) from Cox models were obtained for deferred/intermittent ART versus immediate/continuous ART; analyses were conducted to assess consistency of HRs across baseline-defined subgroups. Results: Among 10156 participants, there were 124 AIDS, 247 SNA, 117 cancers, 103 CVD, and 120 deaths. Interventions in each trial led to similar differences in CD4 count and viral suppression. Pooled HRs (95% confidence interval) of deferred/intermittent ART versus immediate/continuous ART were for AIDS 3.63 (2.37-5.56); SNA 1.62 (1.25-2.09); CVD 1.59 (1.07-2.37); cancer 1.93 (1.32-2.83); and death 1.80 (1.24-2.61). Underlying risk was greater in SMART than START. Given the similar HRs for each trial, absolute risk differences between treatment groups were greater in SMART than START. Pooled HRs were similar across subgroups. Conclusions: Treatment group differences in CD4 count and viral suppression were similar in SMART and START. Likely as a consequence, relative differences in risk of AIDS and SNA between immediate/continuous ART and deferred/intermittent ART were similar. Clinical Trials Registration: NCT00027352 and NCT00867048.

Long-term outcome after adjacent two-level anterior cervical discectomy and fusion using stand-alone plasmaphore-covered titanium cages.

BACKGROUND: Reports on long-term outcome of stand-alone contiguous two-level anterior cervical discectomy and fusion (ACDF) using stand-alone Plasmaphore-coated titanium cages (PCTCs) are rare, and data on follow-ups > 3 years are missing. OBJECTIVE: To evaluate the long-term outcome of adjacent two-level microsurgical ACDF using stand-alone PCTC. PATIENTS/MATERIAL AND METHODS: A total of 33 consecutive patients presented with cervical degenerative disc disease (DDD) underwent contiguous two-level ACDF. Clinical long-term evaluation (mean: 61 ± 14 months) included documentation of neurologic deficits (motor deficits, sensory deficits, reflex status, and gait disturbance), neck pain, and radicular pain. Functional outcome was measured using the Odom criteria, patient-perceived outcome, and evaluation of work status. Radiographs were evaluated to assess intervertebral disc height, subsidence, level of fusion, sagittal balance, and implant position. RESULTS: Surgery was performed at levels C5-C6 and C6-C7 in 30 patients and at C4-C5 and C5-C6 in 3 (mean age: 50.1 ± 7.7 years). Symptoms and neurologic deficits improved as follows: neurologic deficits (pre: 100%; post: 36%), radicular pain (pre: 85%; post: 15%), and neck pain (pre: 94%; post: 33%). Excellent and good functional and subjective outcome was noted in 75%. Cage subsidence was found to be more prominent in the lower (52%) than the upper (36%) mobile cervical segment. Two-level fusion was documented in most patients (n = 29 [88%]). Kyphotic deformity occurred in two cases (n = 2 [6%]). CONCLUSIONS: Stand-alone contiguous two-level ACDF using PCPT proved to be effective, yielding good long-term clinical and functional outcomes. The relatively high rate of subsidence did not affect the good clinical and functional long-term outcome.