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July 19, 2011

27% reduction in HIV disease progression among HSV-2 coinfected subjects treated with acyclovir

Ugandan study shows reduction in HIV disease progression among participants treated with ACV 400mg twice daily

HSV-2 is the most common cause of genital ulcerative disease (GUD), with seroprevalence rates 70-90% among HIV-1 infected individuals. Furthermore, HSV-2 reactivation common and known to increase HIV-1 replication. Despite the enormous success of ART scale up, of 22.5 million HIV infected individuals in sub-Saharan Africa, >85% are NOT yet on treatment: 3.4 million do not have access, and 15.7 million are not yet eligible (pre-ART stage with > 250 CD4 cells/mm3, according to local guidelines). Therefore, strategies to delay HIV disease progression could offset some of the burden faced by countries continuing to scale up treatment with limited resources.

At the IAS meeting in Rome, Steven Reynolds of the NIAID, the Rakai Health Sciences Program, and Johns Hopkins University School of Medicine, discussed the results of a trial to assess the impact of acyclovir 400mg twice daily over 24 months versus placebo on progression to CD4<250 cells/ul or WHO IV (primary endpoint), and impact on HIV viral load, GUD incidence, HSV-2 shedding (secondary endpoints).

Of the 440 participants randomized between May 2007 and Nov 2008 (approximately 70% were female), 205 (46.7%) participants reached primary endpoint, (95 treatment and 110 placebo).

Overall, a 27% reduction in HIV disease progression among participants treated with ACV 400mg twice daily versus placebo (AHR 0.73, 95% CI 0.56-0.97, p=0.029) was noted. Ad for thje impact on HIV viral load, an impact observed among participants with higher baseline HIV VL, particularly among those with >50000 copies/ml (AHR 0.62; 95% CI 0.43-0.96, p=0.03).

Annual rate of change of log10 VL copies/ml overall 0.169 (95% CI 0.032-0.305): with 0.402 (95% CI 0.212-0.592) in the placebo group and -0.061 (95% CI -0.250-0.129) in the ACV group, showing a difference of -0.463 (95% CI -0.731 -0.194, p=0.001) log10 VL copies/ml between the two groups.

Dr. Reynolds concluded that:
--acyclovir 400mg twice daily delayed disease progression among HIV/HSV-2 co-infected individuals,
--acyclovir reduced HIV VL by 0.463 log10 copies/ml consistent with earlier randomized trials,
--treatment of chronic HSV-2 infection may be warranted in HIV infected individuals,
--future studies of valacyclovir (better bioavailability) are warranted and may have an even greater impact on HIV disease progression.


Reynolds S, Makumbi F, Kiwanuka N, et al. Impact of HSV-2 suppressive therapy with daily acyclovir on HIV-1 disease progression: a randomized placebo-controlled trial in Rakai, Uganda [oral abstract]. Presented July 19, 2011 at the 6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy. Abstract TUAB0104.

Source: Reporting for PRN News from Rome, Italy: Jim Braun, DO