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Use of Pentamidine As Secondary Prophylaxis to Prevent Visceral Leishmaniasis Relapse in HIV Infected Patients, the First Twelve Months of a Prospective Cohort Study.

Diro E, Ritmeijer K, Boelaert M, Alves F, Mohammed R, Abongomera C, Ravinetto R, De Crop M, Fikre H, Adera C, Colebunders R, van Loen H, Menten J, Lynen L, Hailu A, van Griensven J - PLoS Negl Trop Dis (2015)

Bottom Line: More patients failed among those with a CD4+cell count ≤ 50 cells/μl, 5/7 (71.4%) than those with counts above 200 cells/μl, 2/12 (16.7%), (p = 0.005).Pentamidine secondary prophylaxis led to a 29% failure rate within one year, much lower than reported in historical controls (50%-100%).Patients with low CD4+cell counts are at increased risk of relapse despite effective initial VL treatment, ART and secondary prophylaxis.

View Article: PubMed Central - PubMed

Affiliation: University of Gondar, Gondar, Ethiopia; Institute of Tropical Medicine, Antwerp, Belgium.

ABSTRACT

Background: Visceral leishmaniasis (VL) has become an important opportunistic infection in persons with HIV-infection in VL-endemic areas. The co-infection leads to profound immunosuppression and high rate of annual VL recurrence. This study assessed the effectiveness, safety and feasibility of monthly pentamidine infusions to prevent recurrence of VL in HIV co-infected patients.

Methods: A single-arm, open-label trial was conducted at two leishmaniasis treatment centers in northwest Ethiopia. HIV-infected patients with a VL episode were included after parasitological cure. Monthly infusions of 4 mg/kg pentamidine-isethionate diluted in normal-saline were started for 12 months. All received antiretroviral therapy (ART). Time-to-relapse or death was the primary end point.

Results: Seventy-four patients were included. The probability of relapse-free survival at 6 months and at 12 months was 79% and 71% respectively. Renal failure, a possible drug-related serious adverse event, occurred in two patients with severe pneumonia. Forty-one patients completed the regimen taking at least 11 of the 12 doses. Main reasons to discontinue were: 15 relapsed, five died and seven became lost to follow-up. More patients failed among those with a CD4+cell count ≤ 50 cells/μl, 5/7 (71.4%) than those with counts above 200 cells/μl, 2/12 (16.7%), (p = 0.005).

Conclusion: Pentamidine secondary prophylaxis led to a 29% failure rate within one year, much lower than reported in historical controls (50%-100%). Patients with low CD4+cell counts are at increased risk of relapse despite effective initial VL treatment, ART and secondary prophylaxis. VL should be detected and treated early enough in patients with HIV infection before profound immune deficiency installs.

No MeSH data available.


Related in: MedlinePlus

Flow chart showing the recruitment process and main outcomes.
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pntd.0004087.g001: Flow chart showing the recruitment process and main outcomes.

Mentions: A CONSORT diagram (Fig 1) and checklist (S1 Checklist) were used to present the patient accounting–total screened, screening failures, enrolled, discontinued and the outcomes. All patients who received a single dose of pentamidine were included in the analyses and the results presented for the three groups: primary VL, relapse and past VL. Baseline characteristics were presented in terms of medians and interquartile ranges for continuous characteristics and using counts and percentages for categorical characteristics.


Use of Pentamidine As Secondary Prophylaxis to Prevent Visceral Leishmaniasis Relapse in HIV Infected Patients, the First Twelve Months of a Prospective Cohort Study.

Diro E, Ritmeijer K, Boelaert M, Alves F, Mohammed R, Abongomera C, Ravinetto R, De Crop M, Fikre H, Adera C, Colebunders R, van Loen H, Menten J, Lynen L, Hailu A, van Griensven J - PLoS Negl Trop Dis (2015)

Flow chart showing the recruitment process and main outcomes.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4591988&req=5

pntd.0004087.g001: Flow chart showing the recruitment process and main outcomes.
Mentions: A CONSORT diagram (Fig 1) and checklist (S1 Checklist) were used to present the patient accounting–total screened, screening failures, enrolled, discontinued and the outcomes. All patients who received a single dose of pentamidine were included in the analyses and the results presented for the three groups: primary VL, relapse and past VL. Baseline characteristics were presented in terms of medians and interquartile ranges for continuous characteristics and using counts and percentages for categorical characteristics.

Bottom Line: More patients failed among those with a CD4+cell count ≤ 50 cells/μl, 5/7 (71.4%) than those with counts above 200 cells/μl, 2/12 (16.7%), (p = 0.005).Pentamidine secondary prophylaxis led to a 29% failure rate within one year, much lower than reported in historical controls (50%-100%).Patients with low CD4+cell counts are at increased risk of relapse despite effective initial VL treatment, ART and secondary prophylaxis.

View Article: PubMed Central - PubMed

Affiliation: University of Gondar, Gondar, Ethiopia; Institute of Tropical Medicine, Antwerp, Belgium.

ABSTRACT

Background: Visceral leishmaniasis (VL) has become an important opportunistic infection in persons with HIV-infection in VL-endemic areas. The co-infection leads to profound immunosuppression and high rate of annual VL recurrence. This study assessed the effectiveness, safety and feasibility of monthly pentamidine infusions to prevent recurrence of VL in HIV co-infected patients.

Methods: A single-arm, open-label trial was conducted at two leishmaniasis treatment centers in northwest Ethiopia. HIV-infected patients with a VL episode were included after parasitological cure. Monthly infusions of 4 mg/kg pentamidine-isethionate diluted in normal-saline were started for 12 months. All received antiretroviral therapy (ART). Time-to-relapse or death was the primary end point.

Results: Seventy-four patients were included. The probability of relapse-free survival at 6 months and at 12 months was 79% and 71% respectively. Renal failure, a possible drug-related serious adverse event, occurred in two patients with severe pneumonia. Forty-one patients completed the regimen taking at least 11 of the 12 doses. Main reasons to discontinue were: 15 relapsed, five died and seven became lost to follow-up. More patients failed among those with a CD4+cell count ≤ 50 cells/μl, 5/7 (71.4%) than those with counts above 200 cells/μl, 2/12 (16.7%), (p = 0.005).

Conclusion: Pentamidine secondary prophylaxis led to a 29% failure rate within one year, much lower than reported in historical controls (50%-100%). Patients with low CD4+cell counts are at increased risk of relapse despite effective initial VL treatment, ART and secondary prophylaxis. VL should be detected and treated early enough in patients with HIV infection before profound immune deficiency installs.

No MeSH data available.


Related in: MedlinePlus