Sunitinib, non-ritonavir-based HAART well-tolerated in patients with HIV

Issue: July 10, 2011

2011 ASCO Annual Meeting

CHICAGO — The rate of non-AIDS-defining cancers in people with HIV taking HAART now exceed that of AIDS-defining cancers in this patient population. Based on this, researchers from the AIDS Malignancy Consortium set out to determine the potential drug-drug interactions between HAART and chemotherapy.

John F. Deeken, MD, of the Georgetown Lombardi Comprehensive Cancer Center, and colleagues conducted the first of several studies that will examine the interaction between new targeted therapies and HAART in patients with HIV. The first study, presented during a poster presentation here today, enrolled 19 patients and was designed to determine the maximum tolerated dose of sunitinib (Sutent, Pfizer).

“Up to this point, oncologists have not had much information about treating cancer in people taking HAART,” Deeken said in a press release. “We're basically at square one because people with HIV usually are not included in cancer clinical trials. They're excluded because physicians are worried about causing further immune suppression in HIV patients, and because HAART drugs are notorious for causing drug-drug interactions and serious side effects.”

Patients were assigned to one of two arms: non-ritonavir-based HAART or ritonavir-based HAART. Those in the first arm were administered the standard dose of sunitinib (50 mg) and those in the second arm underwent a phase 1, three-plus-three dose escalation of sunitinib (25 mg, 37.5 mg and 50 mg). Both arms received sunitinib daily on a 4-week on/2-week off cycle.

The standard dose of sunitinib was well-tolerated in patients taking non-ritonavir-based HAART regimens. Patients treated with sunitinib who received the ritonavir-based therapy experienced more side effects, including higher rates of neutropenia (13%), fatigue (13%) and anemia (6%), compared with those reported in other phase 3 studies of sunitinib, according to the press release.

“Already, we have important information that can impact treatment,” Deeken said in the release. “When the trial is complete, we may have data to recommend that patients take different dosages of sunitinib based on what HAART cocktail they are taking. We also found that patients could keep taking their HIV medications safely, and that sunitinib did not affect the HIV disease status of patients in either group.”

For more information:

Deeken JF. #2591. Presented at: 2011 ASCO Annual Meeting; Chicago; June 3-7, 2011.

Disclosure: Dr. Deeken reported no relevant financial disclosures.

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