Abstract
HIV
On-Site Versus Off-Site Testing
Approximately one-fifth of the more than one million people in the United States infected with HIV do not know they are HIV positive. HIV testing is available in a variety of settings, including in some drug treatment programs. The results of the National Drug Abuse Treatment Clinical Trial Network's HIV Rapid Testing and Counseling Study (CTN 0032) showed that HIV-negative (or status unknown) adults who participated in on-site rapid HIV testing were significantly more likely to receive test results than those referred for off-site HIV testing. Among the participants who received on-site rapid testing, some were randomized to receive HIV risk-reduction counseling, while others did not receive counseling. The results indicate that, at 6 months after testing, there were no significant differences between the two groups in unprotected anal or vaginal intercourse, suggesting no additional benefit from HIV sexual risk-reduction counseling with rapid HIV testing.
Source: Metsch LR, Feaster DJ, Gooden L, et al. Implementing rapid HIV testing with or without risk-reduction counseling in drug treatment centers: results of a randomized trial. Am J Public Health 2012;102:1160–1167.
Cost Effectiveness of PrEP in MSM
More than half of the new HIV infections in the United States each year occur among men who have sex with men (MSM). The Centers for Disease Control and Prevention has published interim guidance for prescribing pre-exposure chemoprophylaxis (PrEP) for HIV prevention in uninfected MSM. Juusola et al. combined a dynamic model of HIV transmission and progression with economic analysis to estimate the effectiveness and cost-effectiveness of PrEP in MSM in the US, comparing the results in the general MSM population and in high-risk MSM. Based on previous clinical trial results, PrEP was assumed to reduce HIV infection risk by 44%. The researchers determined that initiating PrEP in 20% of MSM in the US would lead to a decrease in new HIV infections by about 13%, with a gain of 550,166 quality-adjusted life-years (QALYs) at a cost of $172,091/QALY gained. If PrEP were initiated in all MSM, the cost/QALY gained would rise to $216,480. They found that it is more cost-effective to use PrEP in only high-risk MSM, defined as those with an average of five partners per year. Among this group, PrEP costs about $50,000/QALY gained, and providing PrEP to all high-risk MSM for 20 years would cost an additional $75 billion in health care costs, or $600,000 per case of HIV infection prevented. In contrast, providing PrEP to 20% of all MSM would accrue additional costs of $95 billion, with a rate of $2 million per infection prevented.
Source: Juusola JL, Brandeau ML, Ownes DK, Bendavid E. The cost-effectiveness of pre-exposure prophylaxis for HIV prevention in the United States in men who have sex with men. Ann Intern Med 2012;156:541–550.
Truvada® Gets Nod for HIV Prevention
The Antiviral Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended approval of once-daily oral Truvada (emtricitabine and tenofovir disoproxil fumarate) for use in pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection in HIV-negative adults. The Committee's recommendations are not binding. The vote was 19–3 in favor of approval for use in MSM, 19–2 (1 abstention) in support of use in HIV-uninfected partners in serodiscordant couples, and 12–8 (2 abstentions) in other individuals at risk for acquiring HIV through sexual activity.
Source: Gilead Sciences press release, May 10, 2102. (
Immune Correlates of Vaccine Efficacy
In the RV144 trial, the efficacy of a vaccine regimen against HIV-1 was estimated to be 31.2%. A team of researchers performed a case-control analysis of samples from vaccinated subjects who either did or did not become infected through 42 weeks of follow-up, assaying for six primary immune variables to identify correlates that might be predictive of infection risk. The results identified two antibody correlates of HIV infection risk: binding of IgG antibodies to variable regions 1 and 2 (V1V2) of HIV-1 envelope proteins (Env) correlated inversely with infection; and binding of plasma IgA antibodies to Env correlated directly with HIV-1 infection. The authors hypothesize that high levels of Env-specific IgA antibodies may have mitigated the protective effects of the V1V2-binding IgA antibodies and suggest that this knowledge could be useful in the design of more effective vaccines.
Source: Haynes BF, Gilbert PB, McElrath J, et al. Immune-correlates analysis of an HIV-1 vaccine efficacy trial. N Engl J Med 2012;366;1275–1286.
Bisexual Behavior Among Chinese MSM
A study of young Chinese migrant men who have sex with men (MSM) found that those who also had sex with women (MSMW) were at a very high risk for both HIV infection and transmission. Of the 307 MSM evaluated, 27% were bisexual, and among the MSMW, 8.4% were HIV positive. Compared to the young Chinese MSM, the MSMW were less likely to have undergone HIV testing, to participate in HIV prevention activities, and to be knowledgeable about condom use and HIV/AIDS risk. The rates for unprotected sex for MSMW were 79.5% with female stable sexual partners compared to 59.5% with male stable sexual partners.
Source: Guo Y, Li X, Son Y, Liu Y. Bisexual behavior among Chinese young migrant men who have sex with men: Implications for HIV prevention and intervention. AIDS Care 2012;24:451–458.
Preventive Effects of Male Circumcision
The aim of a study by Gray et al. was to assess the long-term effectiveness of male circumcision on HIV prevention and its impact on HIV-related risk behaviors. The randomized trial conducted in Uganda included nearly 5000 HIV-negative men aged 15–49 years. On completion of the trial, circumcision was offered to the control group, and surveillance was continued for nearly 5 years. During the post-trial surveillance period, the overall HIV incidence was 0.50/100 person-years among circumcised men and 1.93/100 person-years among uncircumcised men, for an adjusted effectiveness of 73%. Among the control-arm participants who underwent post-trial circumcision, HIV incidence was 0.54/100 person-years during the surveillance period, compared to 1.71/100 person-years for the uncircumcised men.
Source: Gray R, Kigozi G, Kong X, et al. The effectiveness of male circumcision for HIV prevention and effects on risk behaviors in a posttrial follow-up study. AIDS 2012;26:609–615.
United States Promotes Male Circumcision in Africa
US Global AIDS Coordinator Eric Goosby told army officers from 80 countries in Africa, Eastern Europe, and central Asia, “We believe male circumcision is a highly significant, lifetime intervention,” and “It makes a lot of sense to put extraordinary resources into it,” at a summit on AIDS and the military. The US has expressed its support for circumcision efforts in African countries, with a goal of reaching 4 million men by 2013. Studies in Africa have demonstrated the effectiveness of male circumcision in significantly reducing HIV transmission, with long-term data indicating risk reduction in the range of 60–75% achievable.
Source: “US Urges Circumcision for Soldiers to Fight HIV in Africa.” Agence France Presse, May 7, 2012.
Anal Cancer Risk in HIV-Positive Women
A study of HIV-infected women asymptomatic for anal disease found that 10.5% had abnormal anal cytology and, among those women, 38.7% had high-grade anal intraepithelial neoplasia (AIN). Risk of high-grade AIN was significantly greater in women with poorly controlled HIV infection. Based on these findings, the authors propose that screening for anal cancer be strongly considered in all HIV-infected women. Furthermore, HIV-infected women with abnormal findings on anal cytology should be referred for high resolution endoscopy. These abnormal cytologies are usually linked to HPV co-infection.
Source: Hou JY, et al. High prevalence of high grade anal intraepithelial neoplasia in HIV-infected women screened for anal cancer. JAIDS 2012;60:169–172.
HPV
Strong Link Between Genital Warts and Cancer
Both men and women with genital warts have a high and long-term risk for anogenital and head and neck cancers. A cohort study of nearly 50,000 individuals with a diagnosis of genital warts found a strong correlation to several forms of cancer, and they remained at increased risk for more than 10 years following the diagnosis. The strongest correlations were for anal, vulvar, vaginal, cervical, and penile cancer, followed by head and neck cancer, including at sites known to be associated with human papilloma virus (HPV) infection.
Source: Blomberg M, Friis S, Munk C, et al. Genital warts and risk of cancer: A Danish study of nearly 50,000 patients with genital warts. J Infect Dis 2012; doi:10.1093/infdis/jis228.
HCV
Dual Drug Treatment Highly Effective
Interim data from a clinical study presented at the European Association for the Study of the Liver (EASL) meeting in Barcelona, Spain, demonstrated a sustained viral response rate of 100% in treatment-naïve patients with genotype 1 HCV treated with a combination of the nucleotide analog polymerase inhibitor GS-7977 (Gilead Sciences, Foster City, CA) and the NS5A inhibitor daclatasvir (Bristol-Myers Squibb, New York, NY), without concomitant administration of ribavirin or pegylated interferon. Among patients with genotypes 2 or 3 HCV, 40 of 44 had undetectable levels of virus at 4 weeks post-treatment.
Source: Berkrot B and Beasley D. Reuters, April 19, 2012.
Positive Trial Results Reported
Abbott presented results from the Co-Pilot Phase 2 study at EASL, reporting a sustained virological response (SVR) at 12 weeks post-treatment in 95%, and 93% of treatment-naïve patients with genotype 1 HCV treated with a 250 mg or 150 mg dose, respectively, of the protease inhibitor ABT-450 boosted by ritonavir, together with the polymerase inhibitor ABT-333 and ribavirin. Furthermore, 47% of patients who had previously not responded to HCV treatment achieved SVR on this regimen. Abbott also reported 24-week results from the Pilot study, in which 91% of genotype 1-infected treatment-naïve patients administered ABT-450/r and ABT-072 combined with ribavirin for 12 weeks had a SVR at 24 weeks.
Source: Abbott Labs press release, April 4, 2012.