Recommendations

Mectizan Expert Committee Statement on Nonresponders in Ghana

January 2006  Recommendation of the Mectizan Expert Committee for mass drug Administration of ivermectin and albendazole for LF elimination in Loa loa-endemic areas where onchocerciasis is also hyper- or meso-Endemic

After a re-review and discussion of the available data by a sub-group of the MEC/AC, the MEC/AC concluded that, there is neither a biological rationale nor available data to suggest that the addition of albendazole to Mectizan would increase the number or severity of adverse reactions if the two drugs were to be used together to treat populations co-endemic for onchocerciasis, LF and loiasis. However, for optimal safety when the combination of albendazole and Mectizan is first utilized in such co-endemic or potentially co-endemic areas, enhanced pharmacovigilance would be appropriate. Based on these assessments and in view of the well recognized inverse relationship between the number of cycles of Mectizan treatment and the incidence of SAEs seen in populations with any of these filarial infections, the specifics of the enhanced pharmacovigilance required need not be the same for all loa/LF/hyper-meso oncho co-endemic or potentially co-endemic areas. In those areas that have already received two or more cycles of Mectizan treatment with good coverage, the level of Loa loa microfilaraemia is likely to be reduced far below levels associated with encephalopathy and other SAEs.

Consequently, it can be recommended that the addition of albendazole could proceed with enhanced passive surveillance as currently recommended for Mectizan administration for onchocerciasis in Loa-endemic areas.

In areas that have received no previous Mectizan treatment, 1 round of prior treatment or have had poor prior coverage, active surveillance similar to that employed at the initiation of the global LF elimination programme should be undertaken until a minimum of 15,000 individuals have been assessed.

Based on the prior data from Cameroon, statistical considerations indicate that this number of individuals would permit the detection of any significant increase in SAEs that might be associated with the addition of albendazole to Mectizan in such Loa-endemic areas. If no increase is seen during this active surveillance, enhanced passive surveillance could then be instituted. To address the risk of Loa loa associated Serious Adverse Experiences (SAEs) after treatment with Mectizan for onchocerciasis, recommendations for the use of Mectizan in areas where the two diseases are co-endemic have been issued by the Mectizan Expert Committee in consultation with the Technical Consultative Committee of the African Programme for Onchocerciasis Control (APOC).

The following pdf files contain the recommendations, which take into account the endemicity of L. loa when assessing the risk of SAEs occurring after Mectizan® treatment for onchocerciasis. Included in the recommendations are annexes that provide guidance for the clinical management of cases of L. loa encephalopathy and a list of suggested medical supplies and equipment for the management of such cases.

We hope that these recommendations will be useful to you.

Should you need further information or clarification of their content, please contact the Mectizan Donation Program.