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Investigational drugs for visceral leishmaniasis.

ABSTRACT: Introduction: The armamentarium of antileishmanial drugs is small. It is further being threatened by the development of resistance and decreasing sensitivity to the available drugs. The development of newer drugs is sorely needed. Areas covered: The authors have based their review on a literature search performed using PubMed. The article specifically looks at investigational drugs, which have demonstrated, at the very least, in vitro and in vivo activities against the leishmania species that cause visceral leishmaniasis. Specifically, the authors review the nitroimidazole compound fexinidazole, which is one of the few drugs which have reached Phase II trials. The article also discusses the R enantiomer of (S)-PA-824, which has shown good antileishmanial activity. Finally, the article also highlights the many novel delivery systems and oral formulations of amphotericin B, which are both cheap and less toxic and are currently under investigation. Expert opinion: Very few new drugs have reached the clinic for this neglected tropical disease and there is an urgent need for new efficacious therapeutics. The authors believe that support from public-private partnerships would help in enabling the prompt development of drug candidates that could potentially make the clinic.

SUBMITTER: Sundar S

PROVIDER: S-EPMC4262729 | biostudies-other | 2015 Jan

REPOSITORIES: biostudies-other

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Investigational drugs for visceral leishmaniasis.

Sundar Shyam S Chakravarty Jaya J

Expert opinion on investigational drugs 20141120 1

Introduction: The armamentarium of antileishmanial drugs is small. It is further being threatened by the development of resistance and decreasing sensitivity to the available drugs. The development of newer drugs is sorely needed. Areas covered: The authors have based their review on a literature search performed using PubMed. The article specifically looks at investigational drugs, which have demonstrated, at the very least, in vitro and in vivo activities against the leishmania species that ca ...[more]

PMID: 25409760

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Project description:Introduction:To sustain the achievement of kala-azar elimination program (KEP), early detection and treatment of the visceral leishmaniasis (VL) cases and associated modalities such as treatment failure (TF), relapse VL (RVL), and Post-kala-azar dermal leishmaniasis (PKDL) is the cornerstone. A predictive biomarker for VL development and related complications could also play a crucial role in curtailing disease incidence and transmission. Investigations to find a biomarker with prospective capabilities are, however, scarce. Using samples and known clinical outcomes generated within two previous longitudinal cohort studies, we aimed to determine if fluctuations in serum anti-rK39 antibody levels could provide such predictive value. Materials and Methods:Serum samples collected at four different time points (Baseline, 12, 18, and 24 months) from 16 patients who had developed VL within the monitoring period and 15 of their asymptomatic healthy controls counterparts were investigated. To investigate potential prediction of VL related complications, serum samples of 32 PKDL, 10 RVL, 07 TF, and 38 cured VL from a single dose AmBisome trial were analyzed. Of this second panel, all patients were monitored for 5 years and sera were collected at four time points (Baseline then 1, 6, and 12 months after treatment). The level of anti-rK39 antibodies in archived samples was measured by a semi-quantitative ELISA. Results:The mean antibody level was significantly higher in VL patients compared to their asymptomatic healthy counterparts at each time point. Likewise, we observed a trend toward elevations in antibody levels for PKDL, RVL, TF relative to the reducing levels observed in cured VL. Receiver operating characteristic (ROC) analysis found a promising predictive power of rK39 antibody levels to reveal progression from asymptomatic Leishmania donovani infection stage to VL, defined as 87.5% sensitive and 95% specific. Following treatment, rk39 antibody notably showed 100% sensitivity and 95% specificity in predicting TF. Conclusion:Our data indicate that the relative quantity of serum anti-rK39 antibody has promise within either a predictive or prognostic algorithm for VL and VL-related modalities. These could enable VL control programs to implement more effective measures to eliminate the disease. Further research is, however, imperative to standardize the rK39 antibody ELISA between sites prior to broader use.

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Investigational drugs for visceral leishmaniasis.

Publications

Investigational drugs for visceral leishmaniasis.

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