Results with Mytesi
Results with Mytesi
Mytesi has been demonstrated to relieve symptoms of noninfectious HIV-related diarrhea in adult patients who are on antiretroviral therapy (ART).
In a clinical study known as the ADVENT trial, 374 adults living with HIV on antiretroviral therapy (ART) who had been experiencing noninfectious diarrhea for at least 1 month were given either 125 mg of Mytesi twice a day or a placebo (sugar pill).1 The study looked at how effective treatment was in an ethnically diverse patient population, comprised predominantly of male long-term survivors (LTSs).*
*LTS is a person living with HIV for >10 years.
Trial participants were:
*ITT population: 125 mg BID (n=136), 250 mg BID (n=54), 500 mg BID (n=46), Placebo BID (n=138).
After 4 weeks of
Mytesi treatment2
~8 out of 10 patients reported a decrease in watery stools
Among these patients, ~6 out of 10 reported at least a 50% decrease in watery stools
After 20 weeks of
Mytesi treatment2
~9 out of 10 patients reported a decrease in watery stools
Among these patients, ~6 out of 10 reported no watery stools
Mytesi is well tolerated3
Mytesi showed no effect on viral load or white blood cell (CD4) counts
People on Mytesi showed no clinically relevant interactions with other drugs
Mytesi’s adverse effects were comparable to those of placebo
References: 1. Gehrig M, Clay P, Perry R, et al. Actual versus perceived use of pharmacokinetic (primarily absorption) influential OTC agents and ART tolerability in a nationwide matched cohort of HIV patients and their healthcare providers. Poster abstract presented at: ID Week 2016; October 26-30, 2016; New Orleans, LA. 2. MacArthur RD, Clay P, Blick G, et al. Long-Term Crofelemer Provides Clinically Relevant Reductions in HIV-Related Diarrhea. Poster presented at: 9th IAS Conference on HIV Science (IAS 2017); 2017 July 23-26; Paris, France. 3. MacArthur RD, Hawkins TN, Brown SJ, et al. Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT Trial): a randomized, double-blind, placebo-controlled, two-stage study. HIV Clinical Trials. 2013;14(6):261-273. doi:10.1310/hct1406-261
