New Developments

HIV Preventive Vaccines

In September 2012, analysis of specimens from RV144, the first HIV vaccine clinical trial to show modest efficacy, offered additional clues as to how the vaccine may have worked.13 The findings built on results published in April 2012,14 showing that certain antibodies may have contributed to protection against HIV infection, whereas other antibodies may have mitigated the effects of protection. In light of these results, the year was one of planning and preparing for trials for the Pox-Protein Public-Private Partnership (P5), launched in 2010 to build on the RV144 results; trials are set to begin in Thailand and South Africa in 2016.

A Phase IIb trial ongoing in 2012, HVTN505, was halted in April 2013 after an independent scientific review board determined that the DNA/rAd5 vaccine regimen being tested was not effective in preventing HIV infection. While not providing the answers hoped for by the field, the results allow for homing in on other vaccine strategies currently in development. In 2012, there were more than 30 vaccine candidates in Phase I trials, with new approaches continuing to enter clinical evaluation.

As in 2011, substantial progress was made in preclinical research on broadly neutralizing antibodies. New knowledge regarding the detailed structure of these antibodies, how they are produced by the immune system, and which sites they target on HIV is paving the way for the design of new vaccine candidates that can elicit these antibodies, and ultimately prevent HIV—in most of its variations—from establishing an infection.

Microbicides

In March 2013, researchers from the VOICE (MTN 003) trial announced that none of the three interventions tested—daily oral tenofovir, daily oral TDF/FTC and daily 1% tenofovir gel—provided protection against HIV among the women in the study population. VOICE data are being examined, but preliminary results suggest that too few women in the trial adhered to prescribed use of the trial products to allow for evaluation of their effectiveness. Several factors may have contributed to the lack of effect seen in VOICE, but there is little doubt that low levels of adherence were a major contributor to trial failure.

Prep

In July 2012, the US Federal Drug Administration (FDA) announced approval of daily application of Gilead Science Inc.’s oral TDF/FTC as PrEP. Also in July 2012, the World Health Organization (WHO) released guidance for PrEP demonstration research trials in serodiscordant couples, men who have sex with men (MSM) and transgender women. Finally, the Southern African HIV Clinicians Society also issued guidance in 2012 for use of TDF/FTC as PrEP in gay men and other MSM—providing the first guidance from the Global South.

Resource Tracking In The News

A Thayer. "Prevention: Antiretroviral Agents May Help Avoid Infection." C&EN Chemical & Engineering News, Vol.86, No.38 (22 September 2008), p. 25.http://pubs.acs.org/cen/coverstory/86/8638cover1box.html

SSA Karim and C Baxter. “PRO 2000: next steps for microbicide development.” Future Virology, Vol.4, No.4 (July 2009), p.317-320.http://www.futuremedicine.com/doi/abs/10.2217/fvl.09.22

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