Access to effective treatment is central in the fight against malaria. The recently published PREGACT study has shown that artemisinin-based combination therapies are effective in pregnant women with malaria in Africa, without the safety concerns of other treatment types. Another success for malaria treatment comes with the World Health Organization’s announcement that the fixed-dose combination of artesunate+mefloquine (ASMQ) shelf-life has been extended from two to three years, which will greatly help with storage and distribution. Both developments will have a positive impact on access to treatment for those who need it.
The PREGACT Study
Pregnant women are highly susceptible to malaria. Malaria infection during pregnancy may increase the risk of foetal loss and maternal death. Considering the harmful effects of malaria during pregnancy, it is vital to treat the disease adequately with effective medicines. WHO previously recommended for all women in malaria-endemic regions in Africa to receive intermittent preventative treatment with sulfadoxine-pyrimethamine, however this is challenged by widespread drug resistance in many regions.
In the PREGACT Study, a total of 3428 women from four sub-Saharan African countries (Burkina Faso, Ghana, Malawi, and Zambia) who were infected with P. falciparum malaria were randomized to one of the following four artemisinin-based combination therapies:
- Artemether-lumefantrine
- Amodiaquine-artesunate
- Dihydroartemisinin-piperaquine
- Mefloquine-artesunate
The trial was conducted as a multi-center, randomized, open-label trial. No significant difference in the rate of serious adverse events and in birth outcomes was found among the treatment groups.
The results showed a parasitological cure at day 63 and improved safety compared to the old treatment regimen.
WHO now recommends patients in the second and third trimester of pregnancy follow a three-day course of therapy. The short-acting artemisinin component reduces the number of parasites over the three days. The partner drug, which is longer-acting, helps to prevent new infections.
This study presents new and much needed evidence that artemisinin-based combination therapies are effective in pregnant women with malaria in Africa, without the safety concerns of sulfadoxine-pyrimethamine.
Extended shelf life for ASMQ
In March 2016, the WHO’s Prequalification Team announced an extended shelf-life from two to three years for the fixed-dose combination of artesunate+mefloquine (ASMQ). The change involves the extension from 24 months to 36 months when packed in Alu-Alu blister. Recommended as a first- or second-line treatment in South America and South-East Asia, the extended shelf life will help to reduce current supply-chain management issues in relation to warehousing and distribution.The longer shelf life applies to the prequalification status of both presentations of ASMQ (25/50mg and 100/200mg) developed by DNDi and Farmanguinhos (Brazil), and manufactured by Cipla.
