The Critical Need for Alternative Antiretroviral Formulations, and Obstacles to Their Development

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Abstract
A 53-year-old black man with advanced human immunodeficiency virus (HIV) disease and hepatitis B coinfection was admitted to the hospital with severe ondynophagia. An upper gastrointestinal endoscopy revealed fungal esophagitis with a bronchial fistula. The patient could take nothing by mouth, so a stent and gastrostomy tube were placed and intravenous antifungal and antibiotic therapy was initiated. However, provision of antiretroviral therapy was more challenging. The patient had failed multiple antiretroviral regimens with development of resistance-associated mutations, but a regimen including tenofovir, etravirine, and raltegravir had potential activity for treating both HIV and hepatitis B infections. The patient’s CD4 count was 73 cells/mm3. Improvement in immunosuppression was key to his lasting recovery, but none of the agents selected were available in a parenteral formulation or a liquid preparation. Data on the safety and efficacy of dissolving or crushing these tablets was limited or lacking, and the best course of treatment for this individual was unclear.

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