7 new treatments delivered, recommended, and implemented

 

MALARIA

Two new fixed-dose combinations (2007 and 2008)

pm_malaria_imageWith older antimalarials increasingly ineffective due to growing resistance,WHO recommended the use of artemisinin-based combination therapies in 2001.

ASAQ (Artesunate+Amodiaquine Fixed-Dose Combination) ASAQ

Thanks to an innovative partnership between DNDi and Sanofi, over 430 million ASAQ treatments have been distributed since 2007. The FDC reduces the pill burden for adults and children alike, and because it dissolves in water, it is easy to administer to infants and young children. Read more

  • Prequalified by WHO in 2008, registered in 32 African countries plus India, Ecuador, and Colombia, and included on the WHO Essential Medicines List for adults and children
  • Available at low prices: US$1 for adults, $0.5 for children
  • No patent: ASAQ was developed as a public good, so provided they met certain quality standards, a generic company interested in producing the drug can do so. Technology transfer to Tanzanian manufacturer Zenufa is ongoing

ASMQ (Artesunate+Mefloquine Fixed-Dose Combination) ASMQ

Thanks to partnerships across four continents addressing formulation, production, clinical trials, and registration, a second safe and efficacious artemisinin-based FDC treatment was made available to treat patients in resource-poor settings. The project was a first-of-its-kind example of South-South technology transfer, as the manufacturing process was transferred from Brazilian public sector laboratory Farmanguinhos to Indian generic company Cipla. Read more

  • Cipla’s product was prequalified by WHO in 2012, the Farmanguinhos one is under review
  • Registered in 11 countries in Asia, Latin America, and Africa, and included on the WHO Essential Medicines List for adults and children
  • Recommended first or second-line treatment in five countries in Latin America and four countries in South East Asia

Implementation activities for ASAQ and ASMQ were handed over to the Medicines for Malaria Venture (MMV) in 2015.

 

SLEEPING SICKNESS

Better, simpler treatment (2009) NECT

pm_hat_imageBefore 2009, the best available treatment for sleeping sickness, involving over 50 intravenous infusions and 14 days in hospital, was so complex to distribute and administer in resource-poor settings, that all-too-often clinicians chose melarsoprol, a highly toxic, arsenic-based drug that kills 5% of those treated with it. In 2009, DNDi clinical trials demonstrated the safety and effectiveness of a simpler and shorter nifurtimox and eflornithine combination therapy (NECT), with considerable benefits for patients, while reducing the logistical and staffing burden on treatment centres in remote locations. Read more

  • Partnership between DNDi, MSF, national control programmes, Bayer, Sanofi, and WHO
  • 100% of stage 2 HAT gambiense patients treated in all 13 endemic African countries
  • NECT included on WHO Essential Medicines List for adults and children Ongoing activities: DNDi continues to support access to NECT in endemic countries.
VISCERAL LEISHMANIASIS

Cheaper, more effective treatment in Africa (2010) SSG&PM

pm_vl_africa_imageFolllowing DNDi clinical trials in East Africa which showed that sodium stibogluconate & paromomycin (SSG&PM) was as safe and effective as the existing standard treatment, WHO recommended the combination be used in the region. Treatment now lasts almost half as long and costs less. More patients can be treated during outbreaks, and the regimen has the potential to fend off resistance and prolong the life of both drugs. Read more

  • Partnership between DNDi, the Leishmaniasis East Africa Platform (LEAP), national control programmes of Kenya, Sudan, Ethiopia, and Uganda, MSF and WHO
  • Recommended by the WHO Expert Committee on the Control of Leishmaniasis for East Africa
  • Helped shape the national guidelines in Sudan, South Sudan, Kenya, Ethiopia, and Somalia
  • Paromomycin registered in Uganda, Kenya, and underway in other East African countries.
CHAGAS DISEASE

First paediatric drug (2011) Benznidazole Paediatric Dosage

pm_chagas_imageDespite recommendations to treat children with Chagas disease, benznidazole, the main drug of choice for treating Chagas, was only available in adult tablet strength. Infants and children were treated with fractioned or macerated tablets, which complicated administration and made dosing imprecise. DNDi‘s partnership with Lafepe enabled the development of the first age-adapted, easy-to-use paediatric dosage form of benznidazole for the treatment of children with Chagas disease. Read more

  • Age-adapted, easy-to-use, and affordable treatment, with an easily dispersible tablet for children under 2 years of age
  • Registered in Brazil
  • Included on WHO Essential Medicines List.
VISCERAL LEISHMANIASIS

Adoption of new treatments in South Asia (2011) New VL Treatments in Asia

pm_vl_south_asia_imageExisting treatment options for VL in South Asia caused severe side effects and were growing ineffective due to resistance. Research was needed to assess the safety and efficacy of and patient compliance to various new treatment options. DNDi convened a consortium of partners to identify the best combination therapies for South Asia. The results spurred the Indian, Bangladeshi, and Nepali Ministries of Health to select, adopt, and implement the best management strategies to support control and elimination of Kala Azar. Read more

  • Large four-arm implementation study with health authorities at national, state and local levels
  • Helped shape the recommendations of the WHO Expert Committee on the Control of Leishmaniases
  • Helped shape the Indian National Roadmap for Kala Azar Elimination recommendations.

 

PAEDIATRIC HIV

More effective treatment for children that also have TB (2016) Superbooster Therapy Paediatric HIV/TB

pm_paed_hiv_imageAmong the many challenges of treating children co-infected with both tuberculosis (TB) and HIV is the fact that a key TB drug negates the effectiveness of ritonavir, one of the main aniretrovirals to treat HIV. A DNDi-sponsored study at five hospitals in South Africa demonstrated the effectiveness of ‘super-boosting’ or adding extra ritonavir to a child’s treatment regimen. WHO has since strengthened recommendations to use super-boosting in TB/HIV co-infected children. Read more

  • Supported by interim results from the study, ‘super-boosting’ ritonavir was recommended by WHO in its antiretroviral guidelines in 2016.