TWO ON YAWS AND YAWS ERADICATION

Monday, 21st of May 2012

‘A single oral dose of azithromycin is non-inferior to benzathine benzylpenicillin and avoids the need for injection equipment and medically trained personnel.’

SINGLE DOSE AZITHROMYCIN AGAINST YAWS

Full text, http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)61624-3/fulltext

Abstract below:

Published Online: The Lancet, 11 January 2012

Single-dose azithromycin versus benzathine benzylpenicillin for treatment of yaws in children in Papua New Guinea: an open-label, non-inferiority, randomised trial

Original Text

Dr Oriol Mitjà MD a b , Russell Hays MD a, Anthony Ipai HEO a, Moses Penias HEO a, Raymond Paru BSc a, David Fagaho BSc a, Elisa de Lazzari MSc b, Quique Bassat PhD b

Summary

Background

Yaws—an endemic treponematosis and, as such, a neglected tropical disease—is re-emerging in children in rural, tropical areas. Oral azithromycin is effective for syphilis. We assessed the efficacy of azithromycin compared with intramuscular long-acting penicillin to treat patients with yaws.

Methods

We did an open-label, non-inferiority, randomised trial at Lihir Medical Centre, Papua New Guinea, between Sept 1, 2010, and Feb 1, 2011. Children aged 6 months to 15 years with a serologically confirmed diagnosis of yaws were randomly allocated, by a computer-generated randomisation sequence, to receive either one 30 mg/kg oral dose of azithromycin or an intramuscular injection of 50 000 units per kg benzathine benzylpenicillin. Investigators were masked to group assignment. The primary endpoint was treatment efficacy, with cure rate defined serologically as a decrease in rapid plasma reagin titre of at least two dilutions by 6 months after treatment, and, in participants with primary ulcers, also by epithelialisation of lesions within 2 weeks. Non-inferiority was shown if the upper limit of the two-sided 95% CI for the difference in rates was lower than 10%. The primary analysis was per protocol. This trial is registered with ClinicalTrials.gov, number NCT01382004.

Findings

We allocated 124 patients to the azithromycin group and 126 to the benzathine benzylpenicillin group. In the per-protocol analysis, after 6 months of follow-up, 106 (96%) of 110 patients in the azithromycin group were cured, compared with 105 (93%) of 113 in the benzathine benzylpenicillin group (treatment difference −3·4%; 95% CI −9·3 to 2·4), thus meeting prespecified criteria for non-inferiority. The number of drug-related adverse events (all mild or moderate) was similar in both treatment groups (ten [8%] in the azithromycin group vs eight [7%] in the benzathine benzylpenicillin group).

Interpretation

A single oral dose of azithromycin is non-inferior to benzathine benzylpenicillin and avoids the need for injection equipment and medically trained personnel. A change to the simpler azithromycin treatment regimen could enable yaws elimination through mass drug administration programmes.

Funding

International SOS and Newcrest Mining.

a Lihir Medical Centre—International SOS, Newcrest Mining, Lihir Island, Papua New Guinea

b Barcelona Centre for International Health Research, Hospital Clinic, University of Barcelona, Barcelona, Spain

Correspondence to: Dr Oriol Mitjà, Department of Medicine, Lihir Medical Center, PO Box 34, Lihir Island, NIP, Papua New Guinea

‘Renewed efforts to eradicate the disease will initially focus on 6 countries – Cameroon, Ghana, Indonesia, Papua New Guinea, the Solomon Islands and Vanuatu – starting with pilot projects in selected districts, and then expanding to other areas and countries within 2 years. In order to move towards the goal set by the roadmap, the support of the World Health Assembly would be critical. The last resolution on endemic treponematoses (yaws, bejel and pinta) was adopted in 1978 (WHA31.58).11’

YAWS ERADICATION

Full text is at http://www.who.int/wer/2012/wer8720.pdf

‘The GPEI continues to face a grave shortfall of just under billion to finance the programme for 2012–2013. Lack of funds has already forced the cancellation and scaling-back of SIAs in 24 countries in the first part of 2012. A continued funding crisis will preclude the full implementation of national emergency plans and jeopardize the goal of a polio-free world.’