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HIV/AIDS and STD Updates
New HIV Prevention Guidelines from the CDC The Centers for Disease Control and Prevention (CDC) has issued an interim guidance on the use of a dual-drug preexposure prophylaxis strategy to prevent HIV infection in men who have sex with men (MSM). Surveillance data suggest that HIV infections have been increasing among MSM for the past 15 years. The guidance was based on the results of the Pre-Exposure Prophylaxis Initiative (iPrEX) study, announced in November 2010, which evaluated the safety and efﬁcacy of preexposure prophylaxis (PrEP) among exposed but uninfected MSM. The phase 3, randomized, double-blinded, placebo-controlled trial compared daily use of the oral antiretroviral agents tenofovir disoproxil fumarate (TDF) and entricitabine (FTC) to placebo, in combination with standard behavioral interventions. Subjects in the PrEP arm had a 44% reduction in HIV acquisition, and this ﬁgure rose to 50% among subjects with 50% or more adherence. Based on the positive study results, the CDC is developing guidelines on the use of PrEP for MSM at high risk of HIV acquisition. Until trials currently underway to assess the safety and efﬁcacy of PrEP in individuals at high risk for HIV infection via other routes of transmission are complete, the CDC recommends that PrEP only be considered in the MSM population. As the prophylactic beneﬁt of a daily TDF/FTC regimen varied with adherence, the CDC emphasizes the importance of support and monitoring to maximize adherence to the prescribed medication regimen. Identifying MSM who are most likely to beneﬁt from PrEP are those at high risk for HIV infection who routinely follow proven risk-reduction measures such as condom use. In the multinational iPrEX study, uninfected men at high risk for HIV infection due to unsafe sexual behaviors took either a combined formulation of 300 mg TDF and 200 mg FTC or placebo. The participants were evaluated every 3 months for an average follow-up period of 1.2 years, and up to 2.8 years. All subjects received regular monitoring of HIV status, risk-reduction counseling, and medication adherence support. The PrEP regimen was associated with HIV risk reduction ranging from 21% among subjects with less than 90% medication adherence to 73% among those with 90% or more adherence. Drug level testing in HIV seroconverters and a matched group of uninfected subjects revealed a 92% reduced risk for HIV acquisition among subjects with detectable levels of TDF/FTC compared to those with no detectable drug. The Interim Guidance was published in the January 28, 2011 issue of MMWR. The February 2011 issue of AIDS Patient Care & STDs features a review of the PrEP, highlighting its promises and pitfalls (2011;25:63–71). Vaccine Effective Against HPV Infection in Males Results of a phase 3 trial of the quadrivalent anti-HPV vaccine GardasilÒ (Merck, Whitehouse Station, NJ) in 4065 males ages 16–26 years showed the vaccine to be effective in at reducing the numbers of external genital lesions among HPVinfected subjects and in preventing anogenital HPV infection. In boys and men with either positive or negative HPV status at baseline, the vaccine was 60.2% more effective than placebo in preventing external genital. This ﬁgure increased to 65.5% for HPV-6, - 11, - 16, or - 18–related lesions. Among the subgroup of study participants that were HPV-negative at enrollment, the vaccine’s efﬁcacy rose to 90.4% among HPV6, - 11, - 16, or - 18 lesions. Initially introduced as a vaccine to protect against HPVrelated disease including cervical cancer and genital warts, GardasilÒ has more recently received approval for the prevention of anal cancer in males and females aged 9–26 years. The study was published in the New England Journal of Medicine 2011;364:401–411. Stroke Risk Increases with HIV Antiretroviral therapy (ART) may increase stroke risk. A review of epidemiologic data designed to identify trends in stroke and comorbid HIV infection during the 10-year period 1997 to 2006 revealed that the proportion of patients hospitalized for stroke (ischemic or hemorrhagic) who were HIV positive increased signiﬁcantly from 0.09% in 1997 to 0.15% in 2006. Even as the number of hospitalizations for stroke in the United States decreased by 7% during this period, the number of patients hospitalized for stroke with comorbid HIV infection increased by 60%. While the percentage of ischemic stroke patients with comorbid HIV infection increased signiﬁcantly (0.08% in 1997 versus 0.18% in 2006), there was not a signiﬁcant change in HIV infection rates among patients with hemorrhagic stroke. The study was published in Neurology 2011;76:444–450. Tuberculosis Protection Before and After Exposure Tuberculosis (TB) is one of the leading causes of death among people infected with HIV. In 2008, TB accounted for 23% of AIDS-related deaths worldwide. In countries with relatively high HIV prevalence, up to 80% of people with TB test positive for HIV, according to the World Health Organization. Approximately 30% of HIV-infected persons globally are estimated to have latent TB infection. The multistage tuberculosis vaccine called H56 was designed for both prophylaxis against TB infection and to combat TB postinfection. The H56 vaccine combines the early-stage antigens Ag85B and ESAT-6 with the latencyassociated protein Rv2660c, which is expressed during later stages of infection. A study conducted in mouse models of tuberculosis has shown that H56 can confer protective immunity in preexposure animals. H56 vaccination in
305:468–470. these new drugs have been shown to increase cure rates. Priority Review in the United States will allow for an accelerated 6-month process. Clinical Outcomes in HIV Infection Vary with Gender. and Geography Gender. When given in combination with the existing drugs pegylated-interferon alfa-2a or alfa-2b and ribavirin. Vertex Pharmaceutical’s oral HCV protease inhibitor. HEPATITIS C VIRUS Introduction The CDC estimates that approximately 3.202 mouse models of latent tuberculosis was associated with better control of disease reactivation and signiﬁcant reductions in bacterial load compared to adjuvant-treated control mice. In phase 3 ¨ trials in treatment-naıve patients. ILLUMINATE. called boceprevir. or BIY) to those infected at birth (vertically infected youths. women tended to have fewer initial symptoms. while southerners and non-whites tended to being ART later. Incidence of pregnancy among behaviorally infected youths was 2. Merck has reported phase 3 trial data that demonstrate signiﬁcantly higher sustained virologic response (SVR) rates with boceprevir (as part of a tri-drug regimen) in both adults who have failed or are new to treatment.8% BIY versus 14. The study was published in Nature Medicine 2011. An estimated 170–200 million people have chronic HCV infection worldwide. or VIY). was awarded FDA Priority Review and EMA Accelerated Assessment. In January. The study was published in JAMA 2011. STD. John Ward. Furthermore. and ribavirin compared to available drugs. new HCV screening guidelines are expected from the CDC.S. director of the Division of Viral Hepatitis at the CDC’s National Center for HIV/AIDS.5 to 5 times greater than among youths without HIV infection. with a greater risk of premature births and spontaneous abortions. New Treatments for Hepatitis C Virus Dr.2 million persons in the United States have chronic HCV infection. however. Merck’s oral HCV protease inhibitor.’’ Before 2011 comes to a close. and TB Prevention. lower viral loads. ‘‘We are on the cusp of a revolution in hepatitis C treatment.3% VIY). They also tend to have poorer pregnancy outcomes.5% BIY versus 21. This follows on the heels of acceptance of telaprevir by European Union drug regulatory authorities for Accelerated Assessment. In a study of 2277 seroconverters. A retrospective study conducted over a 12-year period among young women aged 13–24 years compared pregnancy incidence and outcomes among youths who became infected with HIV as a result of risky behaviors (behaviorally infected youths. and geographic region contribute to differences in symptoms. The study found higher morbidity for nonwhite women than white women. telaprevir. compared to 44% in patients given the existing two-drug therapeutic cocktail.5% VIY had one or more pregnancies during the study period. WOMEN AND HIV/AIDS Higher Pregnancy Incidence and Poorer Outcomes among HIV-Infected Youths Young women who are HIV positive tend to have high pregnancy rates compared to the general youth population. combination therapy with telaprevir achieved viral cure in 75% of patients. and particularly non-white southerners.203:442–451. FDA and Health Canada. pegylated-interferon alfa-2a. had greater HIV-related morbidity. With the development of more effective HCV treatments it will become increasingly important to identify infected persons and offer them treatment.2 million people in the United States are chronically infected with hepatitis C virus (HCV). The results showed that BIY had signiﬁcantly higher pregnancy rates than VIY: 74. recently told a group of health journalists. an oral inhibitor of hepatitis C virus being developed by Vertex Pharmaceuticals. Source: CDC HIV/Hepatitis/STD/TB Prevention News Update Note At least 1 in 4 HCV-infected individuals in the United States do not know their status.17:189– 194. In Canada. Viral Hepatitis. received Priority Review status from both the U. which estimates that approximately 3. with greater than twofold more HIV-related morbidity than men. and use of antiretroviral therapy following primary HIV infection. At least 50% and as many as 90% of HIV-infected injection drug users are also infected with hepatitis C according to CDC estimates. compared to a dual-drug regimen. With regard to ART use. women tended to fare worse as a group. The BIY group was more likely to have more than 1 pregnancy (36. Individuals from southern regions of the United States. with a target FDA review date of May 23. The study was published in the Journal of Infectious Diseases 2011. Vertex also reported evidence to support viral cure in half the time needed with conventional treatment. and higher CD4 + cells at diagnosis compared to men. 2011. The vaccine provided better containment of late-stage infection than vaccines designed to target only early antigens. as discussed in a paper by Swan and colleagues in the December 2010 issue of AIDS Patient Care & STDs (2010. The authors propose that gender and race differences in HIV-related morbidity are primarily a reﬂection of socioeconomic factors. Neither gender nor race was associated with differences in ART response. making it the most common chronic bloodborne HIV/AIDS AND STD UPDATES infection in the United States. Over time. two new anti-HCV drugs could receive FDA approval. and REALIZE—that demonstrate higher viral cure rates for combination therapy with telaprevir. Race. race.24:753–762). morbidity. Vertex has submitted data from three phase 3 studies—ADVANCE. thereby interfering in viral replication. although many are unaware they carry the virus. has also received Priority Review and Accelerated Assessment status. Telaprevir Earns Priority Review Status Telaprevir. . telaprevir could complete the review process within approximately 6–9 months. women began ART sooner than all other study groups. Telaprevir inhibits an HCV protease.
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