While effective combination antiretroviral therapy has dramatically reduced the incidence of opportunistic infections (OIs) among people with HIV, there is still a need for effective therapies for OIs such as candidiasis.

As reported in the February 15, 2007 issue of Clinical Infectious Diseases, researchers evaluated the safety and efficacy of a new oral antifungal agent, posaconazole (Noxafil), in HIV-infected subjects with oropharyngeal and/or esophageal candidiasis who did not respond to oral fluconazole (Diflucan) or itraconazole (Sporanox).

A total of 199 patients received one of 2 oral posaconazole regimens:

• 400 mg twice daily for 3 days, followed by 400 mg once daily for 25 days (n = 103);

• 400 mg twice daily for 28 days (n = 96).

The primary end point was cure or improvement after 28 days. Primary efficacy analyses were performed for the subset of treated subjects with refractory disease (e.g., culture positive for fluconazole- or itraconazole-resistant Candida species at baseline or having persistent or progressive clinical signs or symptoms consistent with treatment failure).

Results

• In the modified intent-to-treat population, 132 of 176 patients (75%) achieved a clinical response to treatment with posaconazole.

• Clinical response rates were similar in patients receiving the 2 regimens (75.3% and 74.7%, respectively).

• Clinical response occurred in

- 67 of 92 subjects (73%) with baseline Candida
  isolates resistant to fluconazole;
- 49 of 66 subjects (74%) with baseline resistance
  to itraconazole;
- 42 of 57 subjects (74%) with baseline resistance
  to both drugs.

• 32 of 43 subjects (74%) with endoscopically documented esophageal candidiasis achieved a clinical response.

• The most common treatment-related adverse events were:

- diarrhea (11%);
- neutropenia (7%);
- flatulence (6%);
- nausea (6%).

• 8 subjects (4%) discontinued therapy due to treatment-related adverse events.

Conclusion

In conclusion, the authors wrote, "Posaconazole offers a safe and effective treatment option for HIV-infected subjects with azole-refractory oropharyngeal candidiasis and/or esophageal candidiasis."

02/09/07

Reference
D J Skiest, J A Vazquez, G M Anstead, and others. Posaconazole for the treatment of azole-refractory oropharyngeal and esophageal candidiasis in subjects with HIV infection. Clinical Infectious Diseases 44(4): 607-614. February 15, 2007.