Search

Between 6-10% of adults with Visceral Leishmaniasis (VL) are co-infected with HIV in Bihar, India. Although it is well known that VL-HIV patients commonly present with advanced HIV disease, there is minimal evidence on the prevalence of tuberculosis (TB) in these patients and no evidence on how best to diagnose and manage this triad. A total of 150 patients with VL and HIV were enrolled in a study investigating AmBisome therapy alone and a combination of AmBisome and Miltefosine. For the first time in the literature, all patients were screened for TB through a combination of chest X-Ray, Cartridge Based Nucleic Acid Amplification Testing (CBNAAT), and Abdominal Ultrasound. Patients were treated initially for VL, then commenced antitubercular therapy (ATT) between days 7-14 depending on the clinical condition, followed by Antiretroviral therapy (ART) two weeks after ATT. A total of 19% (n=28) of patients were co-infected with TB. 25 cases were pulmonary TB, and 3 had Extra pulmonary TB. Five patients were on ATT at enrolment. Seven cases of immune reconstitution inflammatory syndrome (IRIS) associated TB were reported in the study, of which 4 died. The majority (n=5) were unmasking TB. Symptoms predictive of IRIS appeared to be refractory pyrexia more than 10 days after VL treatment initiation and enlarged abdominal necrotic lymph nodes on enrolment ultrasound. Incidence of IRIS reduced with increasing the gap between ATT and ART initiation from two to three weeks for those who were ART naïve, and improved early diagnosis. Case fatality rate of TB-VL-HIV patients was 17.9%(n=5), compared to 1.6% (n=2) in VL-HIV patients (p<0.01). VL-HIV patients should all be screened for TB using CBNAAT. The results suggest that VL treatment results in substantial IRIS that may require delayed initiation of ART, while severe IRIS-associated TB remains a major risk in this cohort of patients. [ABSTRACT FROM AUTHOR]

People living with HIV (PLHIV) have an increased risk of developing visceral leishmaniasis (VL) and poor outcomes compared to HIV-negative individuals. Here, we aim to establish the prevalence and determinants of asymptomatic Leishmania infection (ALI) and the rate and risk factors for progression of ALI to VL in a cohort of PLHIV in Bihar, India. We conducted a cross-sectional survey of PLHIV ≥18 years of age with no history or current diagnosis of VL or PKDL at anti-retroviral therapy centres within VL endemic districts of Bihar. ALI was defined as a positive rK39 ELISA, rK39 RDT, and/or qPCR. Additionally, the urinary Leishmania antigen ELISA was evaluated. The ALI and non-ALI cohorts were followed up every three months for 18 months in person and by telephone, respectively. Determinants for ALI were established using logistic regression model. A total of 1,296 PLHIV enrolled in HIV care, 694 (53.6%) of whom were female and a median age of 39 years (IQR 33–46), were included in the analysis. The baseline prevalence of ALI was 7.4% (n=96). All 96 individuals were positive by rK39 ELISA, while 0.5% (n=6) and 0.4% (n=5) were positive by qPCR and rK39 RDT, respectively. Risk factors for ALI were CD4 counts <100 (OR 3.1; 95%CI 1.2–7.6) and CD4 counts 100-199 (OR=2.1; 95% CI: 1.1-4.0) compared to CD4 counts ≥300, and a household size ≥5 (OR=1.9; 95%CI: 1.1-3.1).Within the ALI cohort, four (3.7%) participants developed VL, compared to no progression in the non-ALI cohort. Mortality rates were higher in ALI compared to non-ALI (OR =2.7; 95% CI: 1.1-6.1). The prevalence of ALI in PLHIV in VL endemic villages in Bihar was relatively high. However, the progression rate from ALI to VL in PLHIV was low. Patients with low CD4 counts and larger household size were at higher risk of ALI. [ABSTRACT FROM AUTHOR]

Background: Kala-azar elimination initiative launched in 2005 in South Asia aims to reach the target by 2017. Early diagnosis and effective treatment is one of the key strategies for control along with integrated vector management. Single dose Ambisome (SDA) and combination regimens are the recommended treatments in South Asia. Our objective was to assess feasibility of using these treatments within the public health facilities and document 12 month outcome. Methods & Materials: This was an open label, prospective, non-randomised, non-comparative, multicentric trial conducted at public health facilities. The study was conducted from Aug 2012 to Sep 2015 at 02 districts (Vaishali and Saran) in Bihar and at kala-azar referral hospital (Rajendra Memorial Research Institute of Medical Sciences) in Patna. In Vaishali district, patients were treated with SDA (10mg/kg) at the District hospital and A+M (single dose Ambisome 5mg/kg + miltefosine 7 days) at 5 primary healthcare centres (PHC). In Saran District, M+P (Miltefosine and Paromomycin) for 10 days at district hospital and 3 PHC. All patients were followed up to document outcome at 6 months and cohort of them were followed for 12 months. Results: 1761 patients were treated in the study, achieved cure rate of > 99% at initial outcome (Day 10) in each treatment arm. The cure rates at 6 months were 90.9% (95% CI 89.0-92.8) for SDA (n=892), 88.8% (CI 85.5-92.1) for A+M (n=357) and 97.0% (CI 95.6- 98.5) for M+P arm (n=512). During 12 month FU (n=1386) there were 11 additional relapses, 2 in SDA (n=706) and 6 in A+M (n=294) and 3 in M+P (n=386). 12 patients developed PKDL in M+P arm, 1 in A+M arm and 2 in SDA. Five SAE occurred in SDA arm, 2 considered related and 3 non-related to Ambisome, all of them resolved. Conclusion: The new treatment regimens showed excellent outcome and safety profile to be used within the programme settings. On the basis of these results, Indian national program have revised the treatment policy in Sep 2014 where SDA has been recommended as the 1st option and M+P as the 2nd option. Extension of FU beyond the standard 6 months yielded additional relapses and PKDL cases. [ABSTRACT FROM AUTHOR]