Regulatory Approval of TDF/FTC Boosts Namibia’s Campaign to end the HIV Epidemic

The approval of TDF/FTC (trade name Truvada®) by the Namibian Medicines Regulatory Council (NMRC) on May 11, 2017, brings renewed hope for achieving an AIDS-free generation in Namibia. The availability and use of TDF/FTC for pre-exposure prophylaxis (PrEP) for adults at high risk of sexually acquired HIV-1 in Namibia could significantly reduce the emergence of new HIV infections among high-risk groups.

SIAPS technical advisors facilitate a session on medicines registration and Pharmadex for the Namibian Medicines Regulatory Council

PrEP is the World Health Organization-recommended use of antiretroviral medicines by those not infected with HIV as a preventative. PrEP is part of Namibia’s comprehensive package of HIV prevention services, as spelled out in the National Strategic Framework for HIV/AIDS and the recently published fifth edition of the Namibia National Guidelines for Antiretroviral Therapy. This timely regulatory approval by the NMRC is the capstone of a transformative year for PrEP in Namibia. Daily oral PrEP is finally taking its place as a core element of HIV prevention in the country. The approval also opens the door for PrEP implementation under both the PEPFAR/DREAMS project to end AIDS among children, adolescents, and young women (https://www.pepfar.gov/partnerships/ppp/dreams/) and the START FREE, STAY FREE, AIDS FREE campaign led by Namibia’s First Lady, Madam Monica Geingos (https://economist.com.na/19987/health/start-free-stay-free-aids-free/).

The USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program facilitated the expedited registration of TDF/FTC and other necessary pharmaceuticals to manage HIV and other diseases. This was part of the SIAPS technical support toward improving efficiency in the registration of pharmaceutical products in Namibia by using an electronic tool called Pharmadex.

With this achievement, Namibia is paving the way for many African and other low- and middle-income countries that have neither registered Truvada® nor started PrEP to reduce the incidence of HIV infections. This significant achievement will go a long way toward enabling Namibia to achieve zero new infections.

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