Table 2.
Summary of factors that explain differences in conclusions between randomized control trials and cohort studies
Variable | Clinical Trial | Cohort Study |
---|---|---|
Selected patients | Patients are often selected; no kidney dysfunction before treatment | Unselected patients who can have CKD before TDF initiation |
Therapeutic history | Frequently naive patients | Frequently ARV-experienced patients |
Associated ARVs | Frequently NNRTI | Frequently boosted PI |
HIV disease | Often, recent diagnosis of HIV infection | Patients more susceptible to having advanced HIV disease |
Studied kidney measure | Decrease of GFR <90 ml/min per 1.72 m2 or even <60 ml/min per 1.72 m2 | Modification of eGFR that can significantly decrease while remaining >90 ml/min per 1.72. m2 |
Follow-up and duration of TDF exposure | Short follow-up (<1 yr) and duration of TDF treatment | Frequently, longer follow-up and exposure duration |
Study finding | More commonly financed by pharmaceutical companies | More commonly independent studies |
Resulting effect | Patients whose kidney function is very likely to benefit from the antiviral effect of TDF | Patients more at risk of cardiovascular and kidney complications of long-term HIV infection and ARV treatment |
NNRTI, non-nucleoside reverse transcription inhibitor.