June Jully June Ju y Welcome to the Queensland

June - Jully, 2008 June - Ju y, 2008 Welcome to the 19th Queensland Positive People (QPP) Treatment Update Newsletter! SUBSCRIIBE FREE ! SUBSCR BE FREE ! Contact Peter on (07) 3013-5505, or Toll-free 1800-636-241, or email: health@qpp.org.au Pllease fforward to Your Friiends and Peers P ease orward to Your Fr ends and Peers The information, comments and editing in this newsletter do not necessarily represent the views of those involved in direct primary medical care… …Always seek the opinion & advice of your doctor. The fiirst IIntegrase IInhiibiitor: The f rst ntegrase nh b tor: IIsentress (ralltegraviir) sentress (ra tegrav r) Now Avaiillablle on the PBS Now Ava ab e on the PBS 1 Jully 2008 1 J u y 2008 Merck Sharp and Dohme have advised the first of a new HIV viral target drug against HIV – an integrase inhibitor - has now been approved on the Pharmaceutical Benefits Scheme (PBS). This new long-awaited HIV treatment is known as Isentress (raltegravir). Integrase Inhibitors are a new class of drugs which target a specific enzyme called “integrase” in the HIV virus life cycle, which prevents HIV integrating in the host human cell DNA (genetic core) further inhibiting the virus from replicating. Isentress is approved for use in combination with other HIV antiretroviral drugs in treatment-experienced people who have some resistance to current drugs and unable to achieve undetectable viral load. It is not approved as an initial starting treatment. For further information, speak to your treating doctor, or contact the NAPWA Treataware Infoline on 1800-817-713, or call your local PLWHA organisation – QPP in Queensland. NEWS FLASH!!! NEWS FLASH!!! Dentall Heallth Denta Hea th Care Pllan Contiinues! Care P an Cont nues! ACT QUIICKLY! ACT QU CKLY! In June this year the Senate successfully blocked the Federal Labour Government’s current attempt to cancel the Enhanced Primary Care (EPC) Chronic Disease Dental Scheme, by passing a Motion for Disallowance. This surprise announcement comes shortly after the scheme was announced to be closing by June 2008. This means that people with HIV (and other chronic and complex conditions) will continue to have access to the Medicare funded dental care through private dentists. The EPC Dental scheme was established in 2007 by the former federal government, which provided for up to $4,250 of dental work per patient (over 2 years); including assessments, extractions, fillings, restorative work (bridges, crowns and implants), dentures, orthodontic services and preventative services (Medicare items 85011-87777). Access to this program must be arranged through your GP (doctor), and it is important that all care-planning requirements are fully met and lodged with Medicare before patients attempt to claim the Medicare benefit. Most HIV+ people will be eligible for this scheme by assessment and referral from their doctor, in conjunction with private dentists who are registered with the scheme. While 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 1 of 8 some private dentists will bulk-bill on this scheme, other dentists might set their own fees and charge you the difference between that and the allowable Medicare rebate. However, any out-of-pocket expenses will count towards the Extended Medicare Safety Net (EMSN) – currently $519.90 for concession card holders and $1,039 for others and families. Although this safety net sets a ceiling on your annual out-of-pocket health care costs, QPP recommends that patients always seek to obtain a written quote from the dentist before starting a course of treatment. This is suggested in the case that a dentist may charge a higher fee for certain procedures over and above that allowed for in the Medicare rebate on items covered in the scheme. It is likely there will be a further vote on this scheme when the Senate meets again on August 26, however the outcome of such a vote will depend on the fine balance of power in the new Senate. In the meantime the EPC dental program is currently open to new patients, so we encourage PLWHA who believe they would benefit from this service to act quickly and seek enrollment by making an appointment with your EPC GP (doctor) as soon practicable! Also, people who have previously enrolled are further eligible to continue their dental-care plan (until a Senate vote might cancel it once again for current and new patients). The previously stated closing date of June 30, 2008 no longer applies, although it is not clear how long the scheme will now be open again. At this stage, it is safe to say the scheme will operate until at least late August. However, predictably, the scheme’s two (2) year treatment coverage may not eventuate, given the current Labour government’s continuing attempt to cancel this scheme. Accessing the scheme may involve some planning time to arrange your appointments, obtain the dental referral and lodge the plan with Medicare, so it’s important to ACT QUICKLY! See www.acon.org.au (search “dental”) for further advice on how to commence the procedure. It is unclear at this stage what alternative measures the Federal Government are proposing to put in place to assist people with chronic conditions, including HIV, with their dental needs. Meantime, additional details about the current EPC Dental Scheme can be obtained from Medicare on 132 011 or www.medicareaustralia.gov.au Thanks to colleagues and staff at NAPWA, AFAO,& ACON for advice and information contained within this article. HIIV Miicrobiiciide Carraguard H V M crob c de Carraguard Safe, but Not Effectiive Safe, but Not Effect ve A recent study has shown that a vaginal microbicide did not prevent HIV infection, but it was safe, rising hopes that it might be combined with drugs or other compounds to work better. The product, Carraguard (an extract from seaweed, made into a gel), is the first HIV microbicide to be tested in advanced trials in women and shown to be safe. Other trials of similar products such as the spermicide called “nonoxynol-9” and another product called “Ushercell” have failed, and in fact made women more likely to become infected with HIV! Carraguard on the other hand did not increase the risk of infection, although infections still occurred but they were similar to women in trial who only got a placebo gel. The Carraguard trial started in 2004 among 6,200 women in South Africa. As a future new technology for HIV prevention, the trial has provided important understanding of the willingness of these women to use a vaginal gel consistently. Only 10% of the women used the gel every time they had sex, and 20% used it only 75% of the time, although male condom use among their partners increased from 33% to 64% (the women were also given condoms). Some interesting questions could be drawn from this study as to whether a rectal microbicide for gay men may confer similar inconsistencies of use if such a microbicide becomes available for gay men (see next article). For men and for women, condoms are still the best and most effective method of preventing HIV transmission. If, in the future, a microbicide is only shown to be only partially effective (e.g. 70%), then its utility will be impeded and still require condom use. If, on the other hand, a gel can prove to be undoubtedly 100% effective in all circumstances then perhaps condoms will not be needed – but so far this has not been achievable…Meantime attempts continue, with other products being developed as microbicides including Gilead’s tenofovir gel, a gel called PRO 2000/5, and Pfizer's newest HIV drug maraviroc. 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 2 of 8 What are Microbicides? A Microbicide is a gel, cream, or flim that can kill viruses and bacteria. When applied directly to the rectum or vagina before sex, a microbicide would either kill HIV and other STIs directly, or prevent them from entering the body. Unlike condoms, a microbicide could be used without a sexual partner’s knowledge. There are currently several microbicides in large-scale trials with result expected between 2008 and 2010. So far trials have only been conducted to see if these products are safe. It is likely that an effective vaginal microbicide to protect against HIV will be available long before a rectal microbicide. For further information on microbicides see: www.avac.org.vaccines.htm www.microbicide.org www.global-campaign.org. www.prepwatch.org Source: Taking a Look- HIV prevention for Gay Men Today. AFAO Publication 2008. check for signs of inflammation and safety. Samples of rectal fluid/mucus were also taken for evaluation of soluble proteins (immune activation markers). Because the data from the 19 people was blinded, the researchers themselves did not know who was getting the real gel or what dose level, nor who was getting the placebo gel. Therefore they cannot be sure whether results are due to the microbicide, the placebo, the participants, or due to chance. However, there were no serious adverse (safety) events in any group. Because the rectum has been largely ‘unknown territory’ in terms of what constitutes a ‘normal’ immune picture, the researchers had to conduct a lot of preliminary studies to determine what tests could be used to demonstrate potential efficacy. Up until now, microbicide studies have suffered from the huge disadvantage that there has been no way of estimating their likely protective effect in humans in sites such as the rectum. Animal models can give unreliable results and there have been no ‘correlates of protection’ such as the immunogenicity markers that have been used in vaccine trials to select promising candidates (though those are currently being called into question). The only way up until now has been to put on a huge and expensive efficacy trial on the basis of results in a handful of monkeys, or even in vitro (test tube) data, and hope the candidate microbicide proves to be effective…Watch this space for future announcements!… Source: www.aidsmap.com Adapted from article by Gus Cairns, Monday, February 25, 2008. Microbicides 2008: First hint of efficacy in rectal microbicide trial, thanks to new biopsy assay. Ref (1st article): Press Release Johannesburg, South Africa and New York, NY: Population Council; Feb 18, 2008. Fiirst hiint of effiicacy iin rectall F rst h nt of eff cacy n recta miicrobiiciide traiill m crob c de tra Groundbreaking data was presented recently at the 2008 Microbicides Conference in Delhi which offered the first hint that a rectal microbicide gel - containing a non-nucleoside (NNRTI) HIV drug (called UC-781) - may prove to be effective at stopping HIV infection. Whilst the data is preliminary it indicates that the drug may be safe, at least if participant’s reports, and the results of numerous tests to measure inflammation chemicals in the body, are reliable indicators of likely harm. This trial is the first series of studies to trial rectal microbicides in humans. Data was presented from the first 19 of 28 people enrolled into the Phase I Safety study, which involves a series of double-blinded trials currently comparing two doses of the NNRTI drug (1% and 2.5%), compared with a placebo. The study is primarily designed as an acceptability study. However, the use of some innovative inflammation tests has allowed early educated guesses to be made about toxicity (safety) and even eventual efficacy. At the beginning of this study 36 males and females were screened for exclusion criteria such as HIV and STI infection. Over a period of weeks the gel microbicide was applied and biopsies – small sections of rectal tissue (a painless procedure) – were taken to look Study Fiinds No Eviidence of Study F nds No Ev dence of Superiinfectiion iin patiients Super nfect on n pat ents experiienciing treatment faiillure exper enc ng treatment fa ure The natural evolution of HIV, rather than superinfection, with a drug-resistant strain of HIV is usually the explanation of antiretroviral treatment failure, according to a Dutch study published in the January 11th edition of AIDS. Transmitted drug resistance can severely limit the antiretroviral treatment choices for HIVpositive people. A significant proportion of new 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 3 of 8 HIV infections (approximately 10% in the UK and 6% in the Netherlands) involve a strain of HIV that is resistant to one or more anti-HIV drugs. In addition, about 30 cases of superinfection with a second or drug-resistant strain of HIV have been reported worldwide. Many gay men choose to have unprotected sex with other HIV-infected men (called serosorting), and Dutch investigators therefore wished to see if superinfection was contributing to the virological (treatment) failure of previously effective antiretroviral therapy. They examined the HIV pol* sequences from 101 patients before anti-HIV therapy was started and after the virologic failure of their treatment. *pol is term used for one of the main replicating genes of HIV. no evidence of superinfection with resistant HIV-1 was observed.” Comments: Even though it might be becoming more common to be first infected with a strain of HIV which is drug resistant (before you even start taking treatments), it may be rarer or unlikely (as this study suggests) that you can be re-infected (i.e. superinfected) with another HIV virus on top of your original one. However, it’s important to note – as this article suggests – that there are exceptions, whereby cases of superinfection have been reported in other settings (“about 30 cases”). Recent research in Melbourne suggests up to 4% of PLWHA may be superinfected. A number of these cases have imparted some serious difficulties for the people concerned and their doctors trying to find treatments that will work – i.e. running out of treatment options and being compelled to take more of them to have an effect. Whilst serosorting (i.e. having unprotected sex with people with definitely known and confirmed HIV) may be a relatively low risk of HIV superinfection, it is additionally important to realise – although this study does not address the matter - the very real, and highly prevalent, risks of contracting many other sexually transmitted infections (STIs) if a condom is not used. While most STIs are treatable, they can be more difficult to treat for people with HIV, and so lead to poorer health and make HIV worse. This in turn makes HIV and STIs easier to pass on. STI lesions and sores may last for longer and your HIV viral load may take a turn for the UP road! It’s rather a circular malady, but think of it this way: Condoms take all the tricky guess work out, leaving more time for fun and flavour, and there’s no need to wonder who has HIV and STIs and who doesn’t! There’s also no need to wonder who has a high HIV load and who doesn’t.....and besides, who wants to take long and drawn out treatments for STIs as well! Enjoy your sex...safely! Meantime, here are some facts about HIV Superinfection to think about: 85 men and 16 women were included in the study. Most of the men (68) were gay. Their viral load fell to undetectable levels usually four months after antiretroviral therapy was started, but then rebounded to detectable levels mostly around the three month mark. Half the patients were starting their first antiretroviral regimen, but eleven of these patients (23%) already had resistance to one or more anti-HIV drugs. The other 50% of patients were already treatment experienced, and 36 (72%) had drug-resistant virus. Resistance tests performed after the emergence of virological failure showed that 81% of patients had drug-resistant virus. Tests showed that 8 individuals had virus that was significantly different after treatment failure compared to the start of anti-HIV therapy. But detailed analysis of HIV gene sequences from these patients showed that such differences were explained by the natural evolution of HIV. In none of the patients did the investigators find any evidence of superinfection or recombination of HIV, even though significant HIV risk behaviour was reported by individuals. Two injecting drug users reported sharing injecting equipment with other drug users, and one injecting drug user reported regular unprotected sex with another HIV-positive individual. In addition, four gay men reported unprotected anal sex in the period between starting antiretroviral therapy and the virological failure of their therapy…The investigators concluded “in this selected subgroup of patients who experienced virological failure while still on initially successful combination antiretroviral therapy, ® We cannot say exactly how often it happens or who is at greatest risk, but we can say: ® It can happen with HIV that is of the same type you already have (with different drug resistance patterns). ® It can happen with HIV that is a different type than you already have (with or without drug resistance). 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 4 of 8 ® If you have HIV and your body is controlling your infection relatively well, it is possible that you can get super-infected a virus that your body will not be able to control so well. ® Superinfection of people, while they are on HIV treatment, has not been observed – but it may happen. Further research in this area is needed. ® It is also possible that superinfection may occur and not always be harmful. ® There are currently no routine laboratory tests you can have to show that you have been superinfected in the past. ® The information about superinfection is of sufficient importance for us to take measures to protect our positive partners and us by practising safe sex and safe injecting combined with traditional antiviral therapies to reduce or even eliminate HCV from infected patients." Current Hep C antiviral medications are effective in only half of infected patients, 70 percent of whom develop chronic infection that can lead to cirrhosis or liver cancer. Since the virus does not integrate its genetic material into the DNA of infected cells the way HIV does, totally clearing the virus could be possible if new cells were not being infected by secreted virus. Grapefruit's bitter taste is caused the presence of the flavonoid naringin, which is metabolized into naringenin, an antioxidant previously reported to help lower cholesterol levels. Research suggests that HCV infects liver cells by, in essence, "hitching a ride" onto the natural lipoprotein-cholesterol metabolic pathway. Since earlier evidence has shown that naringenin can reduce secretion of vLDL from liver cells, the researchers examined whether the compound might also lower HCV secretion from infected cells. Their experiments confirmed that naringenin does reduce the secretion of HCV from infected cell and showed that the compound inhibits the mechanism for secreting a specific lipoprotein that binds HCV. Raymond Chung, another of the study authors said "This approach might eventually be used to treat patients who do not respond to or cannot take traditional interferon-based treatment or be used in combination with other agents to boost success rates." Reference: Bezemer D et al. Combination antiretroviral therapy failure and HIV super-infection. AIDS 22: 309 – 311, 2008. Source: www.aidsmap.com Adapted from article by Michael Carter, Thursday, January 10, 2008 Dutch Find No Evidence of Superinfection in patients experiencing virological failure. Further Information: Recent Melbourne study shows that up to 4% of PLWHA may be superinfected: http://www.watoday.com.au/national/complacent-at-riskof-hiv-superinfection-20080705-32ck.html Thanks to: Jae Condon, ACON, for support in writing this article. Comments: Grapefruiit Compound May Hellp Grapefru t Compound May He p Combat Hepatiitiis C IInfectiion Combat Hepat t s C nfect on A compound that naturally occurs in grapefruit and other citrus fruits (called naringenin) may be able to block the secretion of hepatitis C virus (HCV) from infected cells, a process required to maintain chronic infection. A team of researchers from the Massachusetts General Hospital Center for Engineering in Medicine (MGH-CEM) report that HCV is bound to very low-density lipoprotein (vLDL - a type of "bad" cholesterol) when it is secreted from liver cells and that the viral secretion required to pass infection to other cells may be blocked by the common flavonoid naringenin. If the results of this study extend to human patients, a combination of naringenin and antiviral medication might allow patient to clear the virus from their livers. "By finding that HCV is secreted from infected cells by latching onto vLDL, we have identified a key pathway in the viral lifecycle," said the lead researcher Yaakov Nahmias. "These results suggest that lipid (cholesterol) lowering drugs, as well as supplements, such as naringenin, may be Many drugs, including some HIV drugs, are contraindicated with grapefruit. This means you should NOT to drink or eat grapefruit around the same time as taking HIV medications – both before, during and after dosing (called the “dosing window” period). The naringin in grapefruit STOPS many HIV medications from working, inhibiting their uptake and distribution in your body. Those drugs may fail (by not achieving adequate levels in the body) if grapefruit is taken at the same time. Conversely, some drugs, such as saquinavir (Invirase), are increased in concentration in the body when taken with grapefruit. However, this does not seem to affect the maximum concentration (often linked with increased side effects from the medication). Whilst grapefruit is normally considered a healthy and nutritious food (or juice) which some people like, don’t forget to ask your pharmacist or doctor about it and your medications...Geraldine Moses, a senior pharmacist from the Adverse Medicine Events 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 5 of 8 Information Line (phone 1300 134 237), says there is evidence that an average 200ml glass of normal strength grapefruit juice (straight from the fruit) can cause "a clinically significant interaction with a list of drugs as long as your arm". DOES GRAPEFRUIT AFFECT THE DRUGS YOU TAKE? …READ THE DRUG LABEL OR FIND OUT FROM YOUR PHARAMACIST OR DOCTOR WHICH DRUGS YOU ARE ON WHICH CAN OR CANNOT BE TAKEN WITH GRAPEFRUIT… FOR A LISTING OF AFFECTED MEDICATIONS VISIT: www.australianprescriber.com/magazine/25/2/artid/797 Source: 1. www.hepcaustralia.com.au Tuesday, 05 February 2008. Article adapted from materials provided by Massachusetts General Hospital, via EurekAlert!, a service of AAAS. 2. http://www.sciencedaily.com/releases/2008/02/0802 04124110.htm February 4th, 2008. 3. ABC Health Updates - ABC Health & Wellbeing story: www.abc.net.au/health/talkinghealth/factbuster/stori es/2008/01/23/2123319.htm Thanks to: Paul Harvey, Coordinator – Information & Resources, Hepatitis C Council of NSW Inc. The size of this study is significant, and the results are encouraging, as some antiretroviral drugs can increase cholesterol and other risk factors for heart disease. In the study, the only identified risk factors for a heart-related illness were older age and a pre-existing heart problem before starting antiretrovirals. Comments: The VA Study does not provide information about whether people in this study had other cardiovascular risk factors such as smoking, high blood pressure and diabetes, as these things also ad to the cumulative risk, not just HIV alone. Also the study did not analyse which HIV drug regimens these people were taking, as some treatments may pose more of a risk (such as those that typically raise blood fats in the body). There was also no report on whether people experienced other early warning signs of heart disease like angina (pains in the chest). Do Antiiretroviiralls Do Ant retrov ra s IIncrease Heart Diisease Riisk? ncrease Heart D sease R sk? The use of antiretroviral drugs was found to have a significant benefit in overall survival without any increase in heart disease risks, say researchers of a large study published in the Journal of Acquired Immune Deficiency Syndromes. These new data refute other study results suggesting that HIV treatment raises the risk of cardiovascular complications. Samuel Bozzette, MD, PhD, of the Veterans Medical Research Foundation at the Veterans Affairs San Diego Health Care System, and his colleagues examined the medical records of 41,213 HIV-positive patients in the Veterans Administration (VA) system between 1993 and 2003. Nearly all were male and more than half were African American. Eighty-three percent were between the ages of 35 and 55. Bozzette’s team found that the introduction of combination antiretroviral treatment reduced the rate of death by 75 percent. The rate of inpatient hospital stays for heart-related problems remained stable through the same period, meaning that there were no increases in heart disease due to the introduction of antiretroviral therapy. Whilst this large study was well designed to show these somewhat reassuring results, the results are nonetheless at odds with the majority of other research which suggests a very strong association between heart disease and HIV treatment. Other research shows that a number of antiretroviral regimens have been associated with metabolic disorders (such as diabetes), and these are correspondingly linked to increased risk for atherosclerotic heart disease. The recent D.A.D study data suggests a strong link between abacavir and ddI and risk of heart attack, and that the risk is reversed upon switching to another drug. Previous research analysis also suggests increased risk from Protease Inhibitors (PIs), principally due to their effect on increases in blood fats (lipids)…It’s a mixed bag of a number of cumulative and compound risk factors which are linked to heart disease – between increased risk of specific treatments or classes of treatment, alongside other lifestyle risk factors such as smoking, or traditional risks factors such as being male, older age, family history of heart disease, diabetes, high cholesterol, and high blood pressure…Your doctor is best to advise you whether you are at increased risk or not, based on your individual and specific risk factors. 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 6 of 8 Ask your doctor to predict your risk of heart disease using this tool: disease, were taking other medications as well, or had illnesses such as hepatitis B or C. People taking darunavir (Prezista) are urged to be on the lookout for signs of liver toxicity, and to contact their doctor immediately if they experience any of the following symptoms: dark urine, yellowing of the skin, abdominal pain (especially on the right side below the ribs), general itchiness, decreased appetite, nausea, vomiting, or fatigue. People with pre-existing liver problems (especially hepatitis B or C) are at greater risk of experiencing serious adverse liver events. People taking darunavir (Prezista) are urged NOT to stop taking their drug unless advised to do so by their doctor, and to contact your doctor if you have any concerns. – The Framingham Risk Calculator http://hin.nhlbi.nih.gov/atpiii/calculator.asp You need to first convert your results for Total Cholesterol and HDL Cholesterol (Multiply by 39) If you are at high risk and you smoke, then quitting is one of main things you can do for heart (and lung) health! Ask about support to help you quit smoking… Imagine the money you’ll save and how many people will prefer to kiss YOU! Reference: Bozzette SA et al. Long-term survival and serious cardiovascular events in HIV-infected patients treated with highly active antiretroviral therapy. J Acquir Immune Defic Syndr 2007 Dec 20 Source: www.aidsmap.com VA Study: ART Confers Negligible Risk for Heart Disease. Adapted from article Antiretrovirals Don’t Increase Heart Disease Risk, by Keith Henry, MD AIDS Clin Care. 2008. New Protease IInhiibiitor New Protease nh b tor Duranaviir (Presiizta) Duranav r (Pres zta) Liinked to Liiver Siide-Effects L nked to L ver S de-Effects People with HIV who are taking the antiretroviral drug darunavir (brand name Prezista, formerly known as TMC-114) are being alerted that he drug has been linked to serious liver side effects in a small number of cases, but has included some deaths due to this side effect. Darunavir is a Protease Inhibitor, used in combination with ritonavir (Norvir) to boost its levels. Among patients studied in clinical trials, 0.5 percent developed hepatitis or inflammation of the liver when taking darunavir. Since the drug’s approval in North America, the manufacturer advises there have been 13 reported cases where patients taking darunavir developed hepatitis, including two who died. A further 25 cases have been reported of patients taking darunavir who developed other liver problems between mid2006 and the end of 2007, of whom 14 died. The National Association of People Living with HIV/AIDS (NAPWA) have issued a media alert, but have stressed that it is not known whether the liver complications were cause by darunavir or were due to other medical problems or medications taken by the affected patients, all of whom had advanced HIV Further Information? The Australian Consumer Medicine Information, reflecting this new warning for darunavir (Prezista) has been updated: Click here…Alternatively, you may ask for a copy of the updated consumer information from your pharmacist. Queensland PLWHA, whilst encouraged to speak to you doctor in the first instance, can obtain further information and discussion on this alert by contacting Peter, QPP Health Promotion & Treatments Officer Ph: (07) 3013-5505 or 1800 636 241 (toll-free). Stavudiine and Other Stavud ne and Other Antiiretroviiralls tiied to Diiabetes Ant retrov ra s t ed to D abetes A new report has found that exposure to stavudine (d4T/Zerit) and - to a lesser extentzidovudine (AZT/Retrovir) and didanosine (ddI/Videx) is linked to an increased risk of diabetes in HIV-positive patients. Researchers examined data on 33,389 HIV patients enrolled in the D:A:D [Data Collection on Adverse Events of Anti-HIV Drugs] prospective observational study. Diabetes developed in 744 patients, giving an incidence rate of 5.72 per 1,000 person-years of followup. The actual incidence increased with cumulative exposure (over time) to combination HIV treatment. The adjusted relative rate per year of exposure to the therapy was 1.11. (i.e. 11% increased risk for each year of being on treatment). 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 7 of 8 The strongest association was found with stavudine (d4T), with an adjusted relative risk per year of exposure of 1.19 (i.e. 19% increased risk per year on stavudine containing regimens). Increased risk was also noted with zidovudine (AZT) and didanosine (ddI). Ritonavir (Norvir) and nevirapine (Viramune) were associated with reduced risk. While lipodystrophy was associated with diabetes, adjusting for this factor did not change the relationship with combination HIV treatment. In other words, whether you had lipodystrophy or not, the diabetes association from HIV treatment persisted. Although the researchers said the study did not establish that these drugs directly cause diabetes, they concluded, "Stavudine and zidovudine are significantly associated with diabetes after adjustment for risk factors for diabetes (lipodystrophy) and lipids (blood fats). They speculate that AZT and d4T (known as the “thymidine” drugs) probably directly contribute to insulin resistance [blood sugar problems], potentially through mitochondrial toxicity." Reference: Incidence and Risk Factors for New-Onset Diabetes in HIV-Infected Patients, Diabetes Care, 2008; 31(6):1224-1229. Source: www.medscape.com Stavudine, Antiretrovirals Tied to New Onset Diabetes in HIV. Other Treatments and Research Info Line: A national community-based freecall telephone information service providing the latest HIV treatment information. Lines are open Monday-Friday 2pm-7pm: 1800 817 713 HIV Clinical Trials Database: A user-friendly internet website detailing the HIV Clinical Trials currently running in Australia: www.treataware.info HIV Treatment Checklist: A printed guide on how to maintain good HIV health. This guide is available through the telephone line service. Callers to will be able to discuss a wide variety of HIV treatment issues with trained community educators including: • • • Accurate information about HIV treatment, medications and drugs. Information about other appropriate services and referral supports. Broader issue that affect people on HIV treatments. Treataware Website of the Month Treataware was launched by: Dr. Jonathan Anderson, President of the Australasian Society for HIV Medicine (ASHM) in association with www.treataware.info on Monday 19th May 2008. Treataware is a suite of projects developed by NAPWA, designed to empower all people living with HIV with the knowledge and resources they need to make informed treatment decisions and take effective action for their health maintenance: Treataware aims to enhance, not replace, medical advice provided by your doctor or other health care worker. People living with HIV should regularly see their doctor, who can provide monitoring, up-to-date information, advice and counseling if needed. www.treataware.info 21 Manilla Street, East Brisbane. QLD. 4169. P.O. Box 7403, East Brisbane. QLD. 4169. Web: www.qpp.net.au Ph: Toll Free 1800-636-241 or (07) 3013-5505. Email: pwatts@qpp.org.au Page 8 of 8