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SEPTEMBER 2006
Main Article I :
From Evidence to Action on HIV/AIDS in Prisons: A Report From the XVI International AIDS Conference
Ralf Jürgens, LL.M., Dr.jur Consultant, HIV/AIDS, health, policy and human rights; Co-chair, Track E (Policy), Scientific Program Committee, AIDS 2006 Disclosures: - Nothing to disclose. The XVI International AIDS Conference, "AIDS 2006," took place August 13-18 and attracted 26,000 researchers, physicians, front-line workers, advocates and others involved in the fight against HIV/AIDS from more than 170 countries. More than ever before,1 issues related to HIV/AIDS in prisons were presented and discussed. On the first day of the conference, a satellite meeting organized by the United Nations (UN) Office on Drugs and Crime, the Public Health Agency of Canada and the Correctional Service of Canada debated issues related to HIV/AIDS in prisons in great depth. At the Conference itself, two oral sessions and a large number of poster presentations were dedicated to HIV/AIDS in prisons. In addition, the UN released an important guidance document on issues related to HIV/AIDS in prisons. Most activities focused on HIV prevention, although delegates also heard about efforts to make HIV treatment, including antiretrovirals, available to prisoners in developing countries. While it is impossible to provide a detailed overview of all the prison-related developments presented at AIDS 2006, this article will highlight some of the relevant findings presented at the conference. Prevention: Moving from Evidence to Action Probably the most important development at the conference is an emerging consensus that there is sufficient evidence of the effectiveness of HIV prevention interventions in prisons, and that it is time to move from evidence to action and implement these interventions in prisons. This includes interventions such as condom provision that are currently the subject of much debate in the United States, as well as interventions that have been successfully introduced in other countries, but are rarely if ever discussed in the United States, such as needle and syringe programs in prisons. Because of the importance of HIV prevention in prisons to the overall fight against HIV/AIDS, the World Health Organization (WHO) in 2005 commissioned a review of the effectiveness of HIV interventions in prisons. At one session, Dr Andrew Ball from WHO presented a summary of themain conclusions and recommendations reached by the review, which will soon be published as part of the WHO "Evidence for Action" papers series.2 The review contains the most detailed and rigorous analysis of the evidence related to HIV/AIDS in prisons undertaken to date. In hispresentation, Dr. Ball pointed out that sexual activity within prisons has been reported from around the world; that studies in several nations have shown that injecting drug use is also a reality in many prisons; that even countries that have invested heavily in drug demanand drug supply reduction efforts in prisons have not been able to stop injecting drug use; and that outbreaks of HIV infection have been documented in a number of prison systems, demonstrating how rapidly HIV can spread in prison unless effective action is taken to prevent transmission. He went on to say that HIV programs in prisons often exclude necessary interventions for which evidence of effectiveness exists,and that there is an urgent need to introduce more comprehensive programs. Condom Provision Dr. Ball reported that the available research and the experience of many prison systems in different parts of the world in which condoms are provided to prisoners suggest that providing condoms in prisons is feasible in a wide range of prison settings. No prison system allowing condoms has reversed its policy on condom provision, and none has reported security problems or any other relevant major negative consequences. In particular, it has been found that condom access is unobtrusive to the prison routine, represents no threat to security or operations, does not lead to an increase in sexual activity, and is accepted by most prisoners and correctional officers once it is introduced. Generally, only minor incidents of misuse such as water balloons, water fights and littering were recorded. Studies have not determined whether infections have been prevented due to condom provision in prison. However, data from a variety of settingshave documented the effectiveness of condoms in preventing sexually transmitted infections and there is evidence that prisoners use condoms to prevent infection during sexual activity when they are accessible. Evidence suggests that condoms are more likely to be used if they are easily and discreetly accessible so that they can pick them up at various locations in the prison, without having to ask for them and without being seen by others. Needle and Syringe Programs The first prison needle and syringe program (NSP) in the world was established in Switzerland in 1992. Since then, NSPs have been introduced (or are about to be introduced) in various prison environments in 11 countries in Western and Eastern Europe and in Central Asia. Systematic evaluations of the effects of NSPs on risk behaviors and of their overall effectiveness in prisons were carried out in at least 10 projects in Switzerland, Germany, and Spain. According to Dr. Ball, there is evidence that NSPs are feasible in a wide range of prison settings, including in men's and women's prisons, prisons of all security levels, and small and large prisons. There is also evidence that providing clean needles and syringes is readily accepted by injecting drug users in prisons and may contribute to a significant reduction of syringe sharing over time. It also appears to be effective in reducing resulting HIV infections.3-6 At the same time, there is no evidence to suggest that prison-based NSPs have serious, unintended negative consequences. In particular, the WHO report states that they do not appear to lead to increased drug use or injecting, and needles have not been used as weapons. Evaluations have found that NSPs in prisons actually facilitate referral of drug users to drug dependence treatment programs. Methadone Maintenance Treatment (MMT) A wealth of scientific evidence has shown that, in the community, MMT is the most effective intervention available for the treatment of opiate dependence. MMT has been shown to be effective in improving the physical and social wellbeing of the patient and has been associated with reductions in risk behavior, illegal drug use, criminal behavior, participation in sex work, unemployment, mortality, and HIV transmission. Dr. Ball reported that, more recently, a substantial body of research has delivered significant findings regarding the effectiveness and acceptability of MMT in prison settings:
Dr. Ball pointed out that, in contrast to MMT, other forms of drug dependence treatment have not usually been introduced in prison with HIV prevention as one of their objectives. There is, therefore, little data on the effectiveness of these forms of treatment as an HIV prevention strategy. However, good quality, appropriate, and accessible treatment has the potential of improving prison security, as well as the health and social functioning of prisoners, and it can reduce reoffending. Such treatment in prison can help reduce the amount of drug use in prisons and upon release. But there is a need for independent and systematic outcome evaluations of these interventions, and for examining their effectiveness in reducing injecting drug use and needle sharing. Alternatives to Imprisonment Ultimately, Dr. Ball said, research suggests that reducing the number of people who are in prison because of problems related to their drug use must be a priority. Studies have shown that fear of arrest and sanctions is not a major factor in an individual's decision on whether to use or deal drugs; and that there is little correlation between incarceration rates and drug use prevalence in particular countries or cities. As early as 1987, WHO, in a statement from the first Consultation on Prevention and Control of AIDS in Prisons, said that "[g]overnments may . wish to review their penal admission policies, particularly where drug abusers are concerned, in the light of the AIDS epidemic and its impact on prisons." Prevention in Action: Examples from around the World Other presentations at AIDS 2006 focused on how HIV prevention measures have been introduced in practice in prison environments around the world: Morag MacDonald presented work undertaken in Ukraine to move from evidence about HIV transmission in prison to implementation of HIV prevention measures, notably needle and syringe programs.7 In a study conducted in 2005 in seven prisons in five regions of Ukraine among 831 prisoners, between 16% and 32% of prisoners tested HIV-seropositive, and 75.5 and 91.5% of prisoners tested HCV seropositive in the two prisons in which HCV testing was also undertaken. In addition, an HIV transmission cohort study in two prisons showed that six cases of HIV infection occurred between December 2004 and August 2005 among the 276 prisoners who were still in the cohort in August 2005. Initially, 400 who were in prison for more than six months were recruited to participate in the study. In order to assist the Ukrainian prison system with the implementation of HIV prevention measures in prisons, a partnership was struck between the Ukrainian prison system, a number of Ukrainian non-governmental organizations (NGOs), and the Canadian HIV/AIDS Legal Network. As a result of a number of joint activities, including trainings of senior staff and prison study tours with existing prevention programs, the initial resistance to implementation of pilot needle and syringe projects was overcome, and projects were scheduled to start in 2006. However, the elections in Ukraine and the following long period of political uncertainty have delayed the implementation of the pilot projects. Anak Agung Gede Hartawan from Kerobokan Prison in Bali, Indonesia, described how the prison introduced the first MMT program in a prison in Indonesia.8 Currently, 32 of 785 prisoners receive MMT and the program will soon be expanded to other prisons. If medically indicated, prisoners are allowed to start MMT in prison. Other prisoners are allowed to continue such treatment started in the community. In addition to MMT, condoms and bleach are also available in the prison. Dumitru Laticevschi from Moldova explained how a comprehensive prevention program (including provision of condoms, bleach, needle and syringe programs, and MMT) was introduced in prisons in his country, and how this program has contributed to preventing further spread of HIV among prisoners and, ultimately, to the general community.9 HIV Care, Treatment, and Support Presentations from a number of countries at AIDS 2006 showed that providing HIV therapy for prisoners is a challenge, but is necessary and feasible. The WHO review of existing studies, many of who were undertaken in the United States, showed:
Giving a Voice to (Former) Prisoners For the first time at an International AIDS Conference, delegates were able to hear not only from researchers and staff working in prisons, but also from former prisoners, who are experts on HIV/AIDS in prisons because they live with the disease, know fellow prisoners living with HIV, know what risk behaviors prisoners engage in, and whether or not existing efforts respond to their needs and make a difference. James Motherall, a former prisoner and peer health worker in a federal prison in Canada, said that "the fight against AIDS will not be won until we can reach out to those we are angriest at, until we can extend to our prisoners the same compassion, human rights and dignity that we are prepared to extend to others".14 Connor McCollum, another former prisoner talked about the experience of prisoners living with and/or at risk of HIV and HCV in Canadian prisons.15 Finally, Igor Sobolev from Estonia presented the work of an NGO that has been active since 2002 in prisons, providing support to HIV-infected drug-dependent prisoners.16 What about the United States? At previous conferences, research on HIV/AIDS in prisons from the United States had often been presented in oral sessions. At AIDS 2006, only a number of poster presentations highlighted new developments and findings from the United States. This was due to two factors:
New Resources A final important development at AIDS 2006 was the release, by three UN agencies (the UN Office on Drugs and Crime, the World Health Organization, and UNAIDS), of "HIV/AIDS Prevention, Care, Treatment and Support in Prison Settings: A Framework for an Effective National Response".19 Consistent with the message of the sessions and presentations at the conference, the document emphasizes that "good prison health is good public health," saying that "the vast majority of people committed to prison eventually return to the wider society" and that "therefore reducing the transmission of HIV in prisons is an important element in reducing the spread of infection in society outside of prisons." The document also highlights that "protecting and promoting the health of people in prison benefits not only the prisoners, but also increases workplace health and safety for prison staff." The document stresses, "people in prison are entitled, without discrimination, to a standard of health care equivalent to that available in the outside community, including preventive measures." It calls upon decision-makers "to acknowledge that high risk behaviors for the transmission of HIV occur within prisons - especially injecting drug use, sexual activity, and sexual abuse/violence - and to base decisions affecting prison health on evidence, recognized best practice, and legal and ethical obligations, rather than on public opinion or political expediency." It recommends implementation of comprehensive HIV/AIDS prevention and education (including condoms and sterile needles and syringes), voluntary counseling and HIV testing, HIV/AIDS care and treatment for prisoners, and drug dependence treatment programs in prisons. References: 1 Jürgens R. Is the world finally waking up to HIV/AIDS in prisons? A report from the XV International AIDS Conference. IDCR. 2004;7(9):1-5. 2 Ball A. HIV/AIDS in prisons worldwide - from evidence to action. No. WEBS0301. Available later in 2006 on WHO's web site at www.who.int. 3 Thomas G (2005). Assessing the need for prison-based needle exchange programs in Canada: a situational analysis. Ottawa: Canadian Centre on Substance Abuse; Stöver H, Nelles J (2003). 4 Stark K, et al. 10 years of experience with needle and syringe exchange programs in European prisons: A review of different evaluation studies. International Journal of Drug Policy. 2005;14:437-44. 5 Rutter S, et al. A syringe exchange program in prison as prevention strategy against HIV infection and hepatitis B and C in Berlin, Germany. Epidemiol Infect. 2001;1-6[Epub ahead of print]. 6 Prison-Based Syringe Exchange Programs. A Review of International Research and Program Development (NDARC Technical Report No. 112). Sydney: National Drug and Alcohol Research Centre, University of New South Wales. 7 Jürgens R, et al. From evidence to commitment to action: Implementing HIV prevention measures in prisons in Ukraine. Abstract no. TUAX103. 8 Atmosukarto I, Winarso I, Hartawan AAG, et al. Indonesia introduces the first prison Methadone maintenance treatment (PMMT) in Asia. Abstract no. TUAX105. 9 Laticevschi D. Interventions that work: The Moldova example of harm reduction in prisons. No. WEBS0303. 10 Berger J. Lessons from South Africa? Litigating for treatment access in prisons. No. WEBS0304. 11 Simooya O, Sanjobo N. Challenges and opportunities for scaling up HIV/AIDS care in prisons: A case study from Zambia. Abstract no. TUAX0102. 12 Akpan RC. HIV/AIDS intervention program in the prisons communities in Nigeria. Presented at "HIV/AIDS in Prison: A Comprehensive Response", satellite meeting at the XVI International AIDS Conference, 14 August 2006. 13 Chepkonga MC. Kenya Prisons Service HIV/AIDS Program. Presented at "HIV/AIDS in Prison: A Comprehensive Response", satellite meeting at the XVI International AIDS Conference. 2006. 14 Motherall J. HIV/AIDS in prisons: The point of view of a former prisoner. No. WEBS0301. 15 McCullum C, Howard T. Inside voices speak out - prisoners share stories of living with HIV and HCV. Abstract no. TUAX0101. 16 Sobolev I. It's time to help those who really need it. Presented at "HIV/AIDS in Prison: A Comprehensive Response", satellite meeting at the XVI International AIDS Conference. 2006. 17 Wohl DA, Stephenson B, Schyette A, et al. A randomized trial of a case management intervention to improve access to care, reduce transmission risk behavior and recidivism in HIV-infected prisoners following release: The BRIGHT Study. Poster THPE0784. 18 Haley D, Scheyett A, Golin C, et al. Perceptions of release among incarcerated HIV-infected persons and implications for practice: The UNC Bridges to Good Health and Treatment (BRIGHT) Project Qualitative Substudy. Poster THPE0717. 19 United Nations Office on Drugs and Crime, World Health Organization, and Joint United Nations Program on HIV/AIDS. HIV/AIDS Prevention, Care, Treatment and Support in Prison Settings: A Framework for an Effective National Response. United Nations. 2006. Available at www.unodc.org/pdf/HIV-AIDS_prisons_July06.pdf. SEPTEMBER 2006
Main Article II :
Management of HIV Infection: A summary of data presented at the XVI International AIDS Conference
David Alain Wohl, MD Associate Professor of Medicine Dvision of Infectious Disease AIDS Clinical Trial Unit University of North Carolina-Chapel Hill Disclosures: - Grant Support: Abbott Laboratories, Gilead Sciences, Inc., Roche Pharmaceutical, National Institute of Health; Speakers Bureau: Gilead Sciences, Inc., Abbott Laboratories, Bristol-Myers Squibb, Roche Pharmaceuticals, Boehringer Ingelheim. The International AIDS Conference (IAC) is increasingly becoming a global forum for the presentation of data and information related to the prevention of HIV infection as well as the effects of the disease on the lives of those with HIV/AIDS. Advances in knowledge about HIV pathogenesis and therapeutics have taken a back seat to the pressing social and behavioral dimensions of the epidemic and are now the focus of several smaller conferences and meetings. However, for those with patience, the XVI International AIDS Conference held in Toronto held a few clinical trial gems - most presented on the final day of the conference during the late breaker session. The major findings likely to have implications for the management of HIV-infected individuals in and out of prison/jail are summarized below. Initial HIV Therapy Efavirenz (Sustiva) versus Lopinavir/Rito - navir (Kaletra) The non-nucleoside reverse transcriptase inhibitor (NNRTI), efavirenz and the protease inhibitor (PI) co-formulated drug lopinavir/ritonavir are each anchors of the regimens listed as 'preferred' in the US Department of Health and Human Services (DHHS) guidelines for initial therapy of HIV infection. 1 Both drugs are popular but in many ways these are very different agents. Beyond their disparate targets, they differ in pill count, side effects and cost. However, they share an accumulation of clinical trial data that demonstrate their relative potency in suppressing HIV replication long term. How they stack-up against one another, though, has not been clear. The US AIDS Clinical Trials Group (ACTG) launched study A5142 to compare these antiretroviral behemoths.2 A total of 753 patients on antiretroviral (ART) were randomized to one of three arms: a) two nucleoside reverse transcriptase inhibitors (NRTIs) plus efavirenz; b) two NRTIs plus lopinavir/ritonavir or c) efavirenz plus lopinavir/ritonavir (a novel NRTI-sparing approach). The choice of NRTIs in the first two arms was left to the discretion of the local investigator. The study endpoints included virologic failure (lack of a ten-fold decline in HIV viral load or viral rebound during first 32 weeks of the study or failure to reach a viral load below 200 copies/mL after week 32) and regimen completion (treatment discontinuation for virologic failure or toxicity related discontinuation of regimen component). While many thought they could predict the trial results, few did so correctly. The times to virologic failure and regimen completion were shorter with lopinavir/ritonavir than with efavirenz and the proportion of participants with a viral load below 50 copies/mL at 96 weeks was 89% for efavirenz, 77% for lopinavir/ritonavir and 83% for the combination (the comparison between efavirenz and lopinavir/ritonavir was statistically significant, p = 0.003). The differences between the arms were not as marked when looking at the proportion with viral loads less than 200 copies/mL with more patients in the lopinavir/ritonavir arm having viremia between 50 and 200 copies/mL. The sound of the proverbial other shoe dropping came from the resistance data. While efavirenz and two NRTIs performed the best virologically, the few participants that did fail this combination were more likely to have drug resistance than those experiencing failure in the lopinavir/ritonavir. Of those who were treated with efavirenz and experienced failure, half had evidence of NNRTI resistance and a third had NRTI resistance detected. In contrast, relatively few subjects in the lopinavir/ritonavir group who had virologic failure had detectable resistance mutations (15% NRTI, 4% NNRTI and 0% PI resistance). In addition, despite the virologic results, CD4+ cell count increases were overall greater during treatment with lopinavir/riotnavir than efavirenz (268/mm3 versus 241/mm3, p = 0.01). Limited toxicity data were presented but the three regimens appeared to be similarly well-tolerated; however, hypertriglyceridemia above 750 mg/dL was observed in 14% of the NNRTI/PI arm but only 3-6% of those of those in the other two arms. These important results suggest that virologic suppression to below the limits of assay detection are more likely with an initial regimen containing two NRTIs plus efavirenz than two NRTIs and lopinavir/ritonavir. The trade-off when using dual NRTIs and efeavirenz may be a greater risk of drug resistance among the few that do experience virologic break through and a slightly lower CD4+ cell count response. Further data on lipids and body shape will be forthcoming and will likely help to complete the comparison between these two treatment approaches. Tenofovir/Emtricitibine (Truvada) versus Zidovudine/Lamivudine (Combivir) After deciding whether to use a PI or an NNRTI, the clinician initiating HIV therapy must then choose which NRTIs to add to the mix. Combination formulations of NRTIs have reduced pill count and are a popular choice. Both tenofovir/emtricitabine (TDF/FTC) and zidovudine/lamivudine (ZDV/3TC) are included in the DHHS guideline for first line use and their relative efficacy and tolerability are being studied in a study sponsored by the maker of TDF/FTC, data from which was presented at the IAC.3 This is an open-label, 144-week trial in which 255 treatment-naïve patients were randomly assigned to open-label TDF/FTC plus efavirenz or ZDV/3TC plus efavirenz. Previously, the 48-week data were announced and demonstrated that the proportion of participants with a viral load less than 50 copies/mL at that time point was significantly higher among those receiving TDF/FTC. Importantly, failure was defined using the FDA standard for efficacy, time to loss of virologic response (TLOVR), which requires virologic suppression and no treatment-limiting toxicity. At 48 weeks, adverse effects among those assigned ZDV/3TC largely drove the difference between study arms - given efficacy was judged using the TLOVR composite endpoint. In Toronto, an update of the data at 96 weeks indicate that the differences between the arms have narrowed with no significant difference in the proportion with a viral load less than 50 copies/mL observed between the arms using the TLOVR criteria for failure. However, there was a significant difference in the proportion with a viral load below 400 copies/mL - the main outcome of the study - favoring TDF/FTC (75% in TDF/FTC arm versus 62% in ZDV/3TC arm less than 400 copies/mL at week 96, p = 0.004). In addition, mean CD4+ cell count increases were greater in the TDF/FTC arm versus the ZDV/3TC arm (270/mm3 versus 237/mm3, p=0.036). Again, treatment-limiting toxicity, particularly anemia, was responsible for the relatively poorer performance of ZDV/3TC as the two regimens performed equally when only the viral suppression was considered. Renal function was followed during the study using several measures including serum creatinine and estimations of glomerular filtration rate (GFR) and creatinine clearance (CrCl). Serum creatinine was not observed to significantly change; however, this is considered a crude assessment of renal health. CrCl as calculated by the Cockcroft-Gault equation did not demonstrate a significant difference between arms during the study; a statistically significant decrease in GFR during TDF/FTC treatment was detected using the Modification of Diet in Renal Disease (MDRD) equation. This difference was small (decline from 110 to 100 mL/min/1.73m2 in TDF/FTC arm versus gain of 3 mL/min/1.73m2 in the ZDV/3TC arm, [p =0.006]) and remained stable during the course of the study. The Cockcroft-Gault equation includes weight while the MDRD does not but does consider race as a variable. Note, patients had to have relatively normal renal function to be eligible for participation in this study. As previously demonstrated, DEXA assessed limb fat was seen to decline in the ZDV/3TC group compared to a gain in limb fat in the TDF/FTC subjects. Resistance testing revealed that in both arms, mutations to efavirenz was most common among those with virologic failure, followed by resistance to FTC and 3TC. Thus far, the K65R mutation, which confers broad NRTI resistance and has been associated with tenofovir, was not seen with either study treatment. Simplifying Therapy Interest in simplifying combination HIV therapy has existed almost as long as there has been a three-drug antiretroviral cocktail. Early forays into induction-maintenance strategies produced inconsistent results but with the advent of potent ritonavir-boosted PIs, there have been renewed efforts to distill HAART to a simple regimens - including single drug treatment. Several presentations at the conference examined use of lopinavir/ritonavir as single agent therapy. In one study, lopinavir/ritonavir along with ZDV/3TC was administered to 104 treatment-naïve patients and those who achieved a viral load less than 50 copies/mL by three months then had the NRTIs removed.4 Compared to a control arm receiving ZDV/3TC plus efavirenz, there was no significant difference in virologic suppression below 50 copies/mL at week 96 between the strategies and, interestingly, low level viremia was more commonly seen with lopinavir/ritonavir. In another study, 200 patients with suppressed HIV viremia on HAART were randomly assigned to lopinavir/ritonavir monotherapy or lopinavir/ritonavir plus ZDV/3TC.5 Again, at 48 weeks there was no difference in the proportion of subjects in each arm with a viral load less than 50 copies/mL. Lastly, upping the monotherapy ante, French investigators assigned treatment-naïve patients to lopinavir/ritonavir alone or lopinavir/ritonavir plus ZDV/3TC. 6 In the intent-to-treat analysis the study arms produced rates of viral suppression below 50 copies/mL that were not significantly different. However, an on-treatment analyses demonstrated higher rates of low level viremia in the monotherapy arm. In all three studies, PI resistance during monotherapy was observed in a proportion of those with virologic failure in whom genotype testing was performed strongly suggesting that there is a small but important risk of resistance with this minimalist approach. Monotherapy with a boosted PI holds many attractions but there are risks, as these studies demonstrate, namely increased rates of low level viremia and the possibility of PI resistance. Investigation of boosted PI monotherapy continues, and studies of other agents are ongoing (see News and Reviews). These will help define the role of boosted PI monotherapy. Until then, this is an approach that must be considered investigational. The Treatment-Experienced Patient For patients harboring a drug resistant virus, drugs able to suppress such viral strains are often desperately needed. The recent approval of agents active against drug resistant HIV, particularly tipranavir (Aptivus) and darunavir (Prezista), are important developments in the management of HIV disease and hold out hope for treatment-experienced patients. Updated 48 week data from two large trials of darunavir, POWER 1 and 2 were presented at the IAC.7 Both POWER 1 and 2 studied patients with triple ARV class experience (mean number of PI mutations was three), at least one PI mutation and an HIV RNA level >1,000 copies/mL. The aim of both studies is to determine the optimal dose of the darunavir and its efficacy compared to an investigator selected ritonavir-boosted PI when both were included with optimized ARV regimens using existing drugs informed by resistance testing. In an analysis combining subjects from these two similar studies which compared responses among 131 subjects receiving 600 mg/100 mg of darunavir/ritonavir BID twice daily (the US FDA approved dose) and 124 on an optimized regimen alone, 46% of those assigned darunavir/ritonavir and 10% of the controls achieved a viral load of less than 50 copies/mL at 48 week (p = 0.001). The mean CD4 cell count increase was 102/mm3 versus 19/mm3 for the darunavir/ritonavir and control arms, respectively (P < 0.005). Darunavir/ritonavir was well tolerated without excess toxicity relative to the control arm. Data were also presented on many of the new agents coming down the pike or already pulling into the driveway. Results demonstrating the antiviral activity of TMC-125, an NNRTI with activity against NNRTI-resistant HIV strains8; MK-0518, the first integrase inhibitor that will likely come to market9; the CCR5 inhibitors vicriviroc and maraviroc 10,11 and the maturation inhibitor TNX-35512 were presented and justify an optimistic perspective on the future of HIV therapy. Conclusions The IAC is like no other conference. It is big, boisterous, political and a great opportunity to spot celebrities. While the conference has shifted away from therapeutics, the few clinical trial data presented this year did advance our understanding of the abilities of existing drugs and introduced us to hopeful newer agents. These results had a tough time competing for attention with the speeches by notables and the coverage of the more sensational aspects of the conference, but are of great importance to the enhancement of our care of HIV-infected persons in our correctional facilities. References: 1U.S. Department of Health and Human Services, Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents - May 4, 2006 - www.aidsinfo.nih.gov - accessed September 14, 2006 2Riddler S, et al. IAC 2006. Abstract THLB0204 3Gallant J, et al. IAC 2006. Abstract TUPE0064 4Cameron W, et al. IAC 2006. THLB0201 5Arribas J, et al. IAC 2006. THLB0203 6Delfraissy J-F, et al. IAC 2006. THLB0202 7Lazzarin A, et al. IAC 2006. Abstract TUAB0104 8Cohen C, et al. IAC 2006. Abstract TUPE0061 9Markowitz M, et al. IAC 2006. Abstract THLB0214 10Gulick R, et al. IAC 2006. Abstract THLB0217 11Mayer H, et al. IAC 2006. Abstract THLB0215 12 Norris D, et al. IAC 2006. Abstract THLB0218
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