U=U stands for “Undetectable = Untransmittable”. It is a concept and public health campaign that underscores the fact that people living with HIV who achieve and maintain an undetectable viral load—a level of HIV in the blood so low that it cannot be detected by standard tests—cannot sexually transmit the virus to others.

 

Key Points of U=U:

1. Undetectable Viral Load:
   • Achieved through effective and consistent use of antiretroviral therapy (ART).
   • Regular monitoring and adherence to treatment are crucial to maintaining an undetectable status.
2. Untransmittable:
   • Scientific evidence supports that individuals with an undetectable viral load do not transmit HIV through sexual activity.
   • This greatly reduces the fear and stigma associated with HIV.

The drug approval process in South Africa is rigorous, involving multiple stages of evaluation to ensure safety and efficacy. Cost negotiations, patent considerations, and international agreements like TRIPS play crucial roles in making essential drugs accessible and affordable. This comprehensive approach aims to balance innovation, affordability, and public health needs.

Lenacapavir, marketed under the brand name Sunlenca, has been approved for medical use in several countries, including the United States, the United Kingdom, Canada, and the European Union. It is approved for the treatment of multidrug-resistant HIV-1 infection and is administered as a subcutaneous injection every six months. However, the use of lenacapavir for HIV prevention (PrEP) is still investigational. Clinical trials, such as PURPOSE 1 and PURPOSE 2, are ongoing in various countries, including South Africa, to evaluate its efficacy and safety as a PrEP option. These trials have shown promising results, but regulatory approval for this specific use has not yet been granted in any country. — July 2024