The U.S. Food and Drug Administration (FDA) on December 22, 2022 announced the approval of a new HIV drug called Rukobia (fostemsavir) for adults living with HIV who have limited treatment options. This drug is the first in a new class of HIV medications known as attachment inhibitors, which work by targeting the virus before it enters the body’s immune cells.
Rukobia is specifically indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen, who are unable to use other therapies due to resistance, intolerance, or safety considerations. The medication is taken orally twice daily and is recommended to be used in combination with other antiretroviral drugs.
Clinical Trails
The approval of Rukobia was based on a clinical trial involving heavily treatment-experienced individuals who had limited treatment options due to resistance or intolerance to multiple HIV medications. In this trial, a significantly higher percentage of participants who received Rukobia in combination with other antiretroviral drugs achieved and maintained viral suppression compared to those who received a placebo in combination with other antiretroviral drugs.
Common Side Effects
The most common side effects associated with Rukobia use are nausea, fatigue, and diarrhea, and the medication can also cause serious side effects such as allergic reactions and liver toxicity. As with all HIV medications, patients taking Rukobia should be monitored closely by their healthcare providers.
Conclusion
Overall, the approval of Rukobia provides a much-needed treatment option for adults living with HIV who have limited options due to drug resistance or intolerance. By targeting the virus before it enters the immune cells, attachment inhibitors like Rukobia represent a promising new approach to HIV treatment.
Click here to read the full FDA Announcement