Injectable Cabotegravir Holds Promise as HIV Prevention Stategy

MedicalResearch.com Interview with:

Martin Markowitz MD Clinical Director and Staff Investigator Aaron Diamond AIDS Research Center Aaron Diamond Professor at The Rockefeller University

Dr. Markowitz

Martin Markowitz MD
Clinical Director and Staff Investigator
Aaron Diamond AIDS Research Center
Aaron Diamond Professor at The Rockefeller University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Cabotegravir ((CAB) is an inhibitor of HIV-1 integrase and is amenable to formulation in both oral and long acting injectable forms. In preclinical studies injectable CAB protected against low dose intrarectal challenge using an HIV-like virus in the rhesus macaque model.

These results support the clinical development of CAB as prevention. This study was a first attempt to establish a dosing regimen and evaluate safety and acceptability of intramuscular injections of CAB. The study was a placebo controlled blinded study of approximately 120 subjects with a 5:1 randomization active/placebo. Subjects received 800mg CAB given as 2 2mL injections or placebo every 12 weeks for 3 injections after a 4 week safety lead in of oral therapy. Safety acceptability and PK were assessed.

The main findings were that injections were associated with injection site reactions in the vast majority of participants that were mild to moderate and of short duration. Only 4 subjects who entered the injection phase discontinued due to injection intolerance. There were no additional safety signals and the participants considered the injections acceptable when asked to complete questionnaires. PK analysis found that despite modeling that suggested that the 800mg q 12 week dose would be adequate, this was not the case. More rapid uptake and release from the depot resulted in lower than anticipated drug levels at trough. Alternate dosing regimens are under study.

Another finding is that there were participants (14%) who had detectable drug in plasma detected at 52 weeks after last injection suggesting the presence of a tail in some individuals.

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Pre-exposure Prophylaxis Use by Breastfeeding HIV-Uninfected Women

MedicalResearch.com Interview with:

Kenneth K. Mugwanya MBChB, MS Department of Epidemiology andDepartment of Global Health University of Washington, Seattle, Washington, USA Division of Disease Control, School of Public Health Makerere University Kampala, Uganda

Dr. Kenneth K. Mugwanya

Kenneth K. Mugwanya MBChB, MS
Department of Epidemiology andDepartment of Global Health
University of Washington, Seattle, Washington, USA
Division of Disease Control, School of Public Health
Makerere University
Kampala, Uganda

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Women living in regions with high HIV prevalence are at high risk of HIV acquisition in pregnancy and postpartum because they infrequently use condoms, do not know their partner’s HIV status, and have biologic changes or changes in their partner’s sexual partnerships that increase susceptibility. Moreover, acute HIV infection during pregnancy or breastfeeding period is associated with high rates of mother-to child HIV transmission because of high circulating level of HIV virus in blood. Oral antiretroviral pre-exposure prophylaxis (PrEP) is a powerful HIV prevention strategy recommended by both the World Health organization and US Centers for Diseases Control and Prevention. PrEP is an attractive prevention strategy for women as it can be used discreetly and independent of sexual partners. However, there is limited research about the safety of PrEP in HIV-uninfected pregnant or breastfeeding mothers and their infants.

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Meta-analysis finds that pre-exposure chemoprophylaxis for prevention of HIV infection may be associated with an increase in STDs among MSM

MedicalResearch.com Interview with:
Noah Kojima

David Geffen School of Medicine
University of California
Los Angeles, California

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: One of the most exciting new methods to prevent human immunodeficiency virus (HIV) type 1 infection is through the use of chemical pre-exposure prophylaxis (PrEP), which has been shown to be safe and effective in randomized-controlled trials and “real world” studies among men who have sex with men (MSM). However, reports of high incidence of sexually transmitted infections (STIs) and condomless sex in PrEP trials has led clinicians and public health advocates to be concerned that the use of PrEP for HIV might lead to higher STI incidence due to increased sexual risk behavior. We found that PrEP for HIV infection is associated with increased risk of STI acquisition among MSM in a meta-analysis of prior studies.

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