Abstract
Purpose: To evaluate safety and efficacy of long-term posaconazole in HIV-infected patients with azole-refractory oropharyngeal candidiasis and/or esophageal candidiasis. Method: In this noncomparative, open-label study, participants received oral posaconazole 400 mg twice daily (bid) for 3 months. Enrolled patients (N = 100) included 60 from a previous 1-month acute study of posaconazole and 40 posaconazole-naïve participants. Participants with a clinical response could be followed untreated for up to 1 month afterwards. Participants who relapsed during follow-up, showed improvement at the end of 3 months of treatment (EOT), or were cured but likely to benefit from further therapy could continue on posaconazole 400 mg bid for up to 12 months. Results: In the modified intent-to-treat population, clinical response (cure or improvement) occurred in 85.6% (77/90) at EOT. The results were similar in the previously treated participants and the posaconazole-naïve participants, 88.1 % (52/59) and 80.6% (25/31), respectively. Posaconazole was well-tolerated, showing a similar safety profile during the 3-month study period and during suppressive therapy. The most frequently reported treatment-related adverse event was vomiting (4/100, 4%) during the early follow-up period (on or before day 105) and elevated hepatic enzymes (3/51, 6%) during the long-term foilow-up (after day 105). Conclusion: Oral posaconazole 400 mg bid demonstrated long-term safety, tolerability, and efficacy, offering a long-term, suppressive treatment option for HIV-infected participants with azole-refractory mucosal candidiasis.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 86-97 |
| Number of pages | 12 |
| Journal | HIV Clinical Trials |
| Volume | 8 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 1 2007 |
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Keywords
- Esophageal candidiasis
- Oropharyngeal candidiasis
- Posaconazole
ASJC Scopus subject areas
- Infectious Diseases
- Pharmacology (medical)
Cite this
Safety and efficacy of posaconazole in the long-term treatment of azole-refractory oropharyngeal and esophageal candidiasis in patients with HIV infection. / Vazquez, Jose Antonio; Skiest, D. J.; Tissot-Dupont, H.; Lennox, J. L.; Boparai, N.; Isaacs, R.
In: HIV Clinical Trials, Vol. 8, No. 2, 01.03.2007, p. 86-97.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Safety and efficacy of posaconazole in the long-term treatment of azole-refractory oropharyngeal and esophageal candidiasis in patients with HIV infection
AU - Vazquez, Jose Antonio
AU - Skiest, D. J.
AU - Tissot-Dupont, H.
AU - Lennox, J. L.
AU - Boparai, N.
AU - Isaacs, R.
PY - 2007/3/1
Y1 - 2007/3/1
N2 - Purpose: To evaluate safety and efficacy of long-term posaconazole in HIV-infected patients with azole-refractory oropharyngeal candidiasis and/or esophageal candidiasis. Method: In this noncomparative, open-label study, participants received oral posaconazole 400 mg twice daily (bid) for 3 months. Enrolled patients (N = 100) included 60 from a previous 1-month acute study of posaconazole and 40 posaconazole-naïve participants. Participants with a clinical response could be followed untreated for up to 1 month afterwards. Participants who relapsed during follow-up, showed improvement at the end of 3 months of treatment (EOT), or were cured but likely to benefit from further therapy could continue on posaconazole 400 mg bid for up to 12 months. Results: In the modified intent-to-treat population, clinical response (cure or improvement) occurred in 85.6% (77/90) at EOT. The results were similar in the previously treated participants and the posaconazole-naïve participants, 88.1 % (52/59) and 80.6% (25/31), respectively. Posaconazole was well-tolerated, showing a similar safety profile during the 3-month study period and during suppressive therapy. The most frequently reported treatment-related adverse event was vomiting (4/100, 4%) during the early follow-up period (on or before day 105) and elevated hepatic enzymes (3/51, 6%) during the long-term foilow-up (after day 105). Conclusion: Oral posaconazole 400 mg bid demonstrated long-term safety, tolerability, and efficacy, offering a long-term, suppressive treatment option for HIV-infected participants with azole-refractory mucosal candidiasis.
AB - Purpose: To evaluate safety and efficacy of long-term posaconazole in HIV-infected patients with azole-refractory oropharyngeal candidiasis and/or esophageal candidiasis. Method: In this noncomparative, open-label study, participants received oral posaconazole 400 mg twice daily (bid) for 3 months. Enrolled patients (N = 100) included 60 from a previous 1-month acute study of posaconazole and 40 posaconazole-naïve participants. Participants with a clinical response could be followed untreated for up to 1 month afterwards. Participants who relapsed during follow-up, showed improvement at the end of 3 months of treatment (EOT), or were cured but likely to benefit from further therapy could continue on posaconazole 400 mg bid for up to 12 months. Results: In the modified intent-to-treat population, clinical response (cure or improvement) occurred in 85.6% (77/90) at EOT. The results were similar in the previously treated participants and the posaconazole-naïve participants, 88.1 % (52/59) and 80.6% (25/31), respectively. Posaconazole was well-tolerated, showing a similar safety profile during the 3-month study period and during suppressive therapy. The most frequently reported treatment-related adverse event was vomiting (4/100, 4%) during the early follow-up period (on or before day 105) and elevated hepatic enzymes (3/51, 6%) during the long-term foilow-up (after day 105). Conclusion: Oral posaconazole 400 mg bid demonstrated long-term safety, tolerability, and efficacy, offering a long-term, suppressive treatment option for HIV-infected participants with azole-refractory mucosal candidiasis.
KW - Esophageal candidiasis
KW - Oropharyngeal candidiasis
KW - Posaconazole
UR - http://www.scopus.com/inward/record.url?scp=34250731402&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=34250731402&partnerID=8YFLogxK
U2 - 10.1310/hct0802-86
DO - 10.1310/hct0802-86
M3 - Article
VL - 8
SP - 86
EP - 97
JO - HIV Clinical Trials
JF - HIV Clinical Trials
SN - 1528-4336
IS - 2
ER -