Although U.S. HIV treatment guidelines recommend lamivudine dose reductions for people with kidney impairment, such dose adjustments may often be unnecessary, according to a research paper published in AIDS. The findings may have implications for clinicians and with patients taking any regimen containing lamivudine, a list that includes several common fixed-dose combinations.
The paper examines data from the longitudinal, prospective OPERA cohort. The electronic health records of more than 100,000 people living with HIV in the U.S. were combed for this analysis, with 539 records selected because the person started taking lamivudine and had at least one estimated glomerular filtration rate (eGFR) between 30 and 50 ml/min per 1.73 m2, which signals renal insufficiency.
Of the 539 included OPERA participants, 436 (81%) began taking lamivudine at its full 300 mg daily dose. The remainder started lamivudine at 150 mg/day; demographically, these individuals were more likely to be Black or female, while clinically, they tended to have a higher HIV viral load, a lower eGFR, and a greater likelihood of present comorbidities (most notably diabetes and substance use).
No significant difference was seen between the two groups in terms of the overall incidence of several predefined outcomes of concern, such as incidence of anemia, lactic acidosis, pancreatitis, peripheral neuropathy, or severe lab abnormalities (though the study authors noted that severe lab abnormalities and gastrointestinal distress were more common at baseline among people taking the lower lamivudine dose).
“Evidence indicates that most individuals tolerate higher-than-recommended 3TC and FTC [emtricitabine, Emtriva] doses,” write Brian Wood, M.D., and Anton Pozniak, M.D., in an associated commentary. They noted the potential impact of a reduced lamivudine dose—and the resulting need to switch a patient from a single-pill to a multi-pill regimen—on the quality of life of a person living with HIV whose eGFR drops below 50, relative to the apparent lack of toxicity concerns seen in the current study (among others).
Though the study had limitations and important patient-specific considerations still need to be taken into account on a case-by-case basis, the two write that “the time has come to update treatment guidance to reflect new data and contemporary clinical practice.”