Kidney stones and other calculus build-up seen in 4% of those on Kaletra-based HAART

Kaletra-associated kidney stones and lithiasis (calculus build-up) have been reported in the March 5^th issue of AIDS. Doctors at the Departments of Infectious Diseases and Pharmacology at CHU Nancy, France, report that seven of 165 individuals (4%) experienced either the formation of calculus (e.g. kidney stones), or intense urinary pain on Kaletra-based HAART.

Four individuals — three men and one woman aged between 28 and 57 — experienced renal colic, or intense urinary pain, most likely caused by kidney stones, between eight and 16 months after beginning a Kaletra-based HAART regimen. In addition to Kaletra, all four were taking 3TC, two were on AZT, one was on ddI and one on tenofovir.

Two individuals recovered without treatment and a third case resolved when Kaletra was reduced from 400mg twice daily to 266mg twice daily. Two of the four had previously experienced kidney stones whilst on indinavir, the protease inhibitor (PI) classically associated with this side-effect.

Another two individuals were diagnosed with parotitis, an inflammation of one of the salivary glands situated just in front of or below the ear, similar to mumps, but caused by calculus build-up. One individual had their left parotid gland removed seven months after starting Kaletra-based HAART. The second person suffered moderate pain only. Both remained on Kaletra throughout the complication.

The last case of calculus build-up was seen in a 54-year-old woman who received Kaletra as a part of anti-HIV post-exposure prophylaxis (PEP). A week after starting Kaletra-based PEP, she developed fever with abdominal pain and vomiting, was diagnosed with gallstones, and stopped the PEP. A month later, her gallbladder was removed.

Three of the seven individuals (including two men with kidney stones and the one woman with gallstones) were taking lipid-lowering fibrate medications, which can also cause the build-up of calculus. However, the authors feel that it is more plausible that Kaletra was responsible, even though the exact cause and risk factors associated with this side-effect are unknown.

Kidney stones and other lithiasis are included as side-effects in the Kaletra packaging because these occurred infrequently in the clinical trials that led to the drug being approved. However, until now there had been no reports of its seriousness or frequency.

With a combined rate of 4% for kidney stones, gallstones or other calculus build-up at this French hospital, the authors conclude that “physicians who take charge of patients treated by [Kaletra] should be aware of such adverse events.”