Limits...
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

Kaplan-Meier survival estimate of the main effectiveness analysis.
© Copyright Policy
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4591988&req=5

pntd.0004087.g002: Kaplan-Meier survival estimate of the main effectiveness analysis.

Mentions: The Kaplan-Meier estimated probability of relapse free survival at the end of 6 and 12 months was 79% (95% CI: 67%–87%) and 71% (95% CI: 59–80) respectively (Fig 2), and it was comparable among all the three patient groups. Counting all those who were lost to follow-up and who discontinued for safety or other reasons as failures (i.e. a worst-case scenario), the probability of relapse free-survival was 70% (95%CI: 58%–79%) at 6 months and 61% (95%CI: 49%–71%) at 12 months (Table 3).


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)

Kaplan-Meier survival estimate of the main effectiveness analysis.
© Copyright Policy
Related In: Results  -  Collection

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

pntd.0004087.g002: Kaplan-Meier survival estimate of the main effectiveness analysis.
Mentions: The Kaplan-Meier estimated probability of relapse free survival at the end of 6 and 12 months was 79% (95% CI: 67%–87%) and 71% (95% CI: 59–80) respectively (Fig 2), and it was comparable among all the three patient groups. Counting all those who were lost to follow-up and who discontinued for safety or other reasons as failures (i.e. a worst-case scenario), the probability of relapse free-survival was 70% (95%CI: 58%–79%) at 6 months and 61% (95%CI: 49%–71%) at 12 months (Table 3).

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