The Pan-American Health Organization (PAHO) has succeeded in reducing the price of expensive medicines that can cure people living with hepatitis C (HCV), according to an announcement made at its 57th Directing Council meeting. This significant a move could enable national programmes to scale up diagnosis and treatment and eliminate HCV as a public health problem.
DNDi is piloting a global SIM card service designed by The Foundation for Innovative New Diagnostics (FIND) to send clinical trial data securely from several clinical sites in the Democratic Republic of Congo (DRC). SIMs are small cards containing chips that are used in mobile phones and other connected devices to transmit data over the Internet in a secure manner.
It is with great sadness that DNDi has learned of the passing of Derrick Wong, a highly valued member of the DNDi Board of Directors for six years. Derrick was involved in the creation of DNDi in 2002 and 2003, and he served on the Board and chaired the Finance and Audit Committee from 2011 to 2018. He stepped down from his posts a year ago due to illness.
Fexinidazole, the first all-oral treatment for both stages of HAT caused by T.b gambiense and DNDi’s first new chemical entity, was recommended by the European Medicines Agency in November and registered in Democratic Republic of Congo (DRC) in December 2018. The Phase II/III study on acoziborole opened new clinical sites in DRC and Guinea.
In Africa, results of a Phase III study on HIV/VL in Ethiopia showed high efficacy of a new combination therapy for co-infected patients, a Phase III study began to test new combination treatment for visceral leishmaniasis, and a Phase II study testing new treatments for PKDL started in Sudan. In Asia, the results of an infectivity study in Bangladesh confirmed that PKDL acts as a reservoir for leishmaniasis infection, with implications for elimination efforts across South Asia. In Latin America, the Brazilian Ministry of Health is reviewing its treatment policy to consider the adoption of AmBisome as the country’s first-line visceral leishmaniasis treatment.
A Phase II study of new benznidazole regimens was completed in 2018 with results coming in 2019. A Phase II study of fexinidazole, a new drug being tested for Chagas, completed patient recruitment in 2018. New diagnosis and treatment access projects were launched in Guatemala and Brazil, and the project in Colombia showed major increases in people tested in pilot areas.
The first-ever double-blind, randomized clinical trial for fungal mycetoma, underway in Sudan, had enrolled 84 patients by January 2019, the threshold for interim analysis. The primary objective of the study is to demonstrate the superiority of fosravuconazole over the current standard, itraconazole.
As development continues for a “4-in-1” fixed-dose combination (abacavir/lamivudine/ lopinavir/ritonavir) for young children, interim results of the LIVING study for an optimized “2-in-1” lopinavir/ritonavir paediatric formulation were released. The study – which enrolled over 1,000 children in sub-Saharan Africa – showed that 83% of children were virologically suppressed at 48 weeks, compared to 55% at the beginning of the study.
The first stage of the clinical trial in Malaysia and Thailand testing the ravidasvir/sofosbuvir combination showed excellent results in 301 chronically infected adults, as 97% of those enrolled were cured. Cure rates were notably high for the hardest-to-treat patients. Stage 2 of the study, to confirm the pangenotypic potential of the combination, has started.
DNDi has joined partners from 35 countries attending the Sixth International Conference on Mycetoma in Khartoum, Sudan to endorse a ‘Call for Action’ to accelerate global efforts to address the plight of mycetoma patients. The Call for Action urges the global health community to work together with health ministries, multilateral agencies, research institutions, pharmaceutical companies, and other partners to address the devastating consequences of this highly neglected disease.