Evaluating HIV/AIDS education and prevention models targeting minorities, mobile and migrant populations: A systematic literature review


The 2008-2011 aids&mobility project aimed to improve health literacy and awareness among the immigrant population of HIV and the health service availability by training young migrants as certified transcultural mediators to promote health and prevention in their communities.
The project established its activities and target population on included a systematic literature review of the scientific literature. The literature wes also the frame of reference for the evaluation and publication of results.
Evaluation was based on the folllowing:
– Outcomes of the HIV health promotion activities and drug-related programs aimed at increasing access to counselling, testing and treatment;
– Method used to measure outocoms;
– Method used to calculate effectiveness calculated and whether comparable to economic modelling; eventual “social accounting”;
– Policy recommendations to ensure program sustainability;
The review describes the results of the analysis of relevant research articles identified through a systematic database search.

Articolo presente in – HAART and correlated pathologies n. 20

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A Haemophilia, HIV and osteoporosis: an emerging problem in clinical practice

HIV infection is an important co-morbidity in haemophilia. Some evidences suggest that both these pathologies are related to a reduction in bone mineral density. We describe the complexity in management of a femoral fracture in a patient with severe haemophilia and a long history of treatment for HIV infection.

Articolo presente in – HAART and correlated pathologies n. 14

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WHO Viral Hepatitis. Resolution one year after – A talk with Charles Gore

In May 2010 World Health Assembly adopted the Viral Hepatitis Resolution, after years of jointed effort run by community organizations and clinicians across the globe. Charles Gore, the President of the World Hepatitis Alliance had the opportunity to address the Assembly that adopted the resolution: The World Health Organisation and the member States must develop a global strategy for hepatitis prevention and control.
World Hepatitis Alliance will be a key partner in that process. It happens in the same time when new drugs are going to be available for patients and clinicians –who shortly will have more new therapeutical options: the anti-HCV drugs pipe line is really great –but also when we are all experiencing a deep financial crisis. To address all these question I have met Charles Gore in Berlin, during the EASL meeting: exactly one year later our first talk together.

We are one year later the World Health Organization resolution about hepatitis, where we are now?

Well, it’s wonderful that we have the resolution, unfortunately there has not been quite as much progress as I would have liked and that is partly because WHO is a big organization and it takes time. One of the things that the resolution mandated was the development of a global strategy for the prevention and control of viral hepatitis and for that to happen there needs to be a unit in Geneva to do that because the hepatitis work that WHO has done in the past has been diversified throughout the organization, one person doing a little bit here and another person doing a little bit there and that’s actually in a way why it has never been properly tackled in my view.
Now that is going to be it needs to have a coordinating unit, but clearly recruiting new people, particularly at a time when the financial constraints makes it hard. So it’s going a little bit slower and obviously the unit is also needed to coordinate World Hepatitis Day, because now that’s an official day, it’s up to WHO to organize it and the World Hepatitis Alliance is very ready to help them and has offered our services to do that but, again, it’s a question of it perhaps being a little slower than we would like, but at least we are beginning to move in the right direction.

Can you provide us a global picture about hepatitis C?

It is a very big problem globally hepatitis C with between 130 and 170 million people chronically infected.
Somewhere around a third of a million deaths a year and it’s everywhere: it’s not like some disease which is concentrated in specific bits of the world. Almost every single country has a problem with it where at least 1 in a 100, if not considerably more, are chronically infected and one of the problems is that wherever you look most of those people are undiagnosed and so they are the ones who are most likely to develop end-stage liver disease, because they would not have had access to treatment that could stop that.

How can we reach people that are not informed about their status that are undiagnosed?

That’s exactly the reason that WHO agreed to hold a World Hepatitis Day.
When we set out on the route to trying to get this to happen, we were told there are many too many Days, there will never be another one officially endorsed by WHO, but we spoke to the 193 Member States and convinced them that this was an exceptional case.
At the meetings at the Executive Board and at the Assembly that I attended, it was perfectly clear from what each country was saying that they wanted the Day for two reasons, diagnosis and prevention, because that’s what’s needed, so clearly one day won’t be enough, but the Day on July we will at least be the focal point for it.

You have used the word “chronic” many times: from your point of view, what means living with a chronic condition?

It affects your entire life. I lived with hepatitis C for 20 years, for most of those, I didn’t know that I had it. It was only after I was diagnosed that I realized that explained why I felt tired all the time, why I had little enthusiasm for things and it really affected my ability to perform throughout my life. And then, once I was diagnosed, there was the stigma attached to it, because certainly in the West, although this is not true elsewhere, hepatitis C is stigmatized as a drug users’ disease. But, in fact, there are many routes of transmission. As I say, this is not true in other parts of the world: nosocomial infection in hospital or in healthcare settings generally is much more common that intravenous drug using in most of the world. So, certainly my experience of feeling stigmatized, not wanting to tell people, feeling isolated, perhaps not that for going and looking for support, and the fact that you have it day after day, after day: there is also something about having a chronic infectious disease that is perhaps a little different from having just a normal chronic disease. I did treatment because I was worried about the state of my liver. I was already cirrhotic when I did hepatitis C treatment, but actually, after it had worked for me and the virus had been eradicated, the first time I saw on my doctor’s request for bloods “no known infection risk” I was so elated, so overjoyed: at that time I realized that subconsciously I had been really concerned about being infectious to other people, to the people I cared about and the relief of seeing that was enormous.

We are at the beginning of a new era regarding new treatments, there is a lot of noise about protease inhibitors and hepatitis C, before speaking about the future, looking at the current therapies, what are the unmet needs or the limits of the current therapies?

The problem with the current therapies is that they are not very effective or not effective enough against genotype 1, 4, 5 and 6, they are effective for 2 and pretty effective for 3, but the others are not. I have in my office two people and also a third, who is actually not in the office but was a trustee, who tried treatment, it did not work for them because they were type 1 and having no other options their liver disease progressed. All three have had to have liver transplants and that’s a real problem, because there are not enough livers for transplant and there are increasing numbers of people needing them. So, there is a huge unmet need for people who have either decided they don’t want to do treatment because the odds are not good enough, or for people who tried it and for whom it hasn’t worked.

What are your expectations about new treatments?

That they are going to make an enormous difference.
One is the increased efficacy, but also the shorter duration: part of the problem is I actually got very sick on treatment and had to stop after eight months, but it worked, it had worked by then. It’s very clear: six months is different from a year. If you got to do it for a year, certainly by the time I had to stop. I was getting seriously exhausted by it, it’s the relentlessness of it of feeling pretty ill day after day after day: being able to shorten that six months will make an appreciable difference.
The fact that people are much more likely to have a successful outcome, people are prepared to put up with side effects. It’s much easier, if you really think this is going to work. So, this is the beginning of a new era, a different class of drugs, the direct-acting antivirals, and I think one of the most exciting things is the fact that this is one of the disease areas where we have absolutely the most investment from the pharmaceutical industry and there is huge competition, so there is an awful lot going on and I am sure you have seen the level of excitement at this Conference with so many new drugs.

New drugs very often means high prices, we are at the beginning of a new that is also characterized by a financial crisis, what is your position about the issue of price?

Yes, this is very unfortunate that these are coming out now, at this particular time in the middle of a financial crisis. The thing about price is that this is a complicated issue. On the one hand, it is absolutely essential that the people who need these medicines can afford them, but at the same time there needs to be the financial incentive for pharmaceutical companies to go on investing. Part of the reason that we have such a lot of drugs, and developed so much competition that is speeding everything up is because of this model. You know, people talk about the pharmaceutical industry are very bad: we should have a different model to do it, we should perhaps do it in universities, or we should have free intellectual property. The thing is, well, that just doesn’t work in the same way that this does in terms of getting focused huge investment into an area, and that brings on new and better drugs and the point is we need them: we need the investment to bring us drugs that will be more effective, have less side effects and that you need to take for a shorter duration. So, my answer is this is a complicated question.

Are you working with pharmaceutical companies in order to set up studies related to quality of life or other psychosocial issues related to new treatment?

Not at the moment, we have done that, the NGO that I run in the UK has been doing some work on this, but the Alliance hasn’t been because the Alliance at the moment is a very small organization. What we are committed to doing first of all is capacity building with our members, because what we need is credible national strategies in every country, as a first, a fast requirement. After that, we can spread out and do more, but there are very few countries now that have proper national strategies and someone to lead them in place. So, we are working on that primarily, and also clearly on awareness, as well as working with WHO around a global strategy that will help inform national strategies: we are not this enormous organization that can be doing that kind of thing, working with the drug companies in that kind of detail, yet.

So, once again, scientific breakthrough is crucial but access is the gatekeeper on the territory?

Of course, there is no point in having scientific breakthroughs if – you know? – less than 1% of people can access these wonderful breakthroughs, but how you make it possible for the maximum number of people to get access is a complicated question. If you look at HIV, interesting work has been done and there have been a range of model and that has allowed access and that’s what we are going to have to look at in hepatitis C and we are going to need to look at it quickly.

Articolo presente in – HAART and correlated pathologies n. 13

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Assisted reproduction in HIV positive couples


HIV-discordant couples are significantly increasing. The availability of new and more effective antiretroviral drugs has resulted in HIV discordant couples increasingly and a growing demand of parenting. We followed HIV discordant couples with an integrated multidisciplinary project of assisted reproductive technology (ART) to prevent horizontal transmission.
Women of childbearing age are HIV positive have significant complications in gynecological and reproductive health, but the availability of new and more effective antiretroviral agents, has prompted new possibilities for women HIV positive resulting in demand for maternity. The reproductive assistance to HIV positive women in almost all European countries is extremely difficult due to problems of structures, ethics, legal issues and prejudices.
The PMA techniques and in particular the ICSI provide HIV-positive couples to a safe and highly effective way to achieve pregnancy.

Articolo presente in – HAART and correlated pathologies n. 12

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Predictive criteria of sustained virological response (more than 60 months) to Nevirapine-based antiretroviral treatment


Nevirapine (NVP) was the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to be used for the treatment of HIV infection. NVP is generally a well tollerated drug; early adverse events, such as hypersensitive reactions and hepatic toxicity, are the main limitations. A considerable number of patients obtain a durable virological success for a long time.
The aim of this study is to identify predictive criteria for long term NVP virological response (more than 60 months) in a cohort of NNRTIs naive subjects.

Patients and methods
Clinical records of 137 HIV positive subjects treated with a NVP-including regimen were retrospectively reviewed for age, sex, route of HIV transmission, clinical stage, HCV co-infection, therapeutic regimens, length of treatment, side effects, hepatic and metabolic blood values, reasons for treatment failure.

128 patients were included into the study. Twenty eight of them (22%) were still on treatment. Main reasons leading to NVP discontinuation were virological failure (32.8%) after a median of 16.2 months (IQR 8.1-37.9), toxicity (21.9%) (1 month, IQR 0.8-5), patient’s choice (21.1%) (17.6 months, IQR 2.8-39). Hypersensitivity was the more frequent adverse reason leading to interruption (p<0.009). Thirty nine (30.5%) subjects were treated for more than 60 months (long term responders or LTRs), 89 (69.5%) stopped NVP before 60 months (long term not responders or LTNRs). LTRs were older (41.2 years (IQR 36-49.6) vs 36.6 (IQR 32.1-42.7) (p=0.012), with a lower median baseline HIV RNA viral load (2.6 log10 vs 3.7 log10 ) (p=0.01). Conclusions
In conclusion, older patients, with lower HIV RNA viral load at baseline have a greater probability to maintain a sustained virological response with a NVP-based treatment over 60 months.

Articolo presente in – HAART and correlated pathologies n. 12

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Darunavir and acute HIV-related demyelinating polyneuropathy: a new possible treatment?

At this moment the role of new protease inhibitors in the onset of HIV-related demyelinating polyneuropathy remains a controversial topic. We describe the improvement of AIDP after introduction of boosted Darunavir plus Tenofovir/ Emtricitabine in a HIV positive patient naïve for antiretroviral therapy. The regression of the neurological symptoms was associated with the introduction of protease inhibitors in absence of traditional treatment strategies for demyelinating polyneuropathy. Further studies are needed to establish their potential use in the treatment of HIV-1 related demyelinating polyneuropathy.

Keywords: Generic drug; Co-formulation; Antiretroviral therapy.

Articolo presente in – HAART and correlated pathologies n. 11

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Generic Drugs: What Antiretroviral Scenario is Expecting?


The prevalence of HIV-infected patients in antiretroviral treatment is continuously increasing in western world due to longer survival, changes in guidelines for initiation of treatment and immigration from poor resources countries: the cost of drugs will inevitably drive the future choices. Since for an always larger number of antiretroviral drugs the patent is going to expire in the next few years, the generic drugs may let great cost reduction. One of the immediate issues that the clinicians are going to face, is the “disruption” of the actual drugs co-formulations (that is >1 drug in one pill) for economic reasons. However, the patent expiration of the antiretroviral drugs might allow in the next years different coformulations with respect to those currently available. The role of the generic drugs in antiretroviral therapy is still well undefined but probably they will occupy a larger and larger market share: the implications of this change for clinical practice are not fully understandable at the present time, but clinicians and authorities should evaluate advantages and disadvantages, avoiding opportunistic choices or defensive positions, in order to offer the best cost-effective treatment to the largest number of HIV patients.
Keywords: Generic drug; Co-formulation; Antiretroviral therapy.

Articolo presente in – HAART and correlated pathologies n. 11

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Genotypic Resistance Profiles in patients failing Darunavir Containing Regimens: The Role Of Interpretation Algorithms


The study aimed at defining protease (PR) resistance mutations associated with darunavir (DRV) failure and PR resistance evolution at DRV failure, in a large database of HIV patients. Overall, 1104 patients were included: only 118 (10.7%) failed at a median observation time of 16 months. The mean number of PR mutations at baseline was 2.7, but it was higher in patients who subsequently failed DRV (3.8 vs. 2.6). In addition the number of PR mutations increased at failure (mean 4.3). The higher statistical difference at baseline between failing vs. non-failing patients was observed for V32I and I84V mutations. At DRV failure the major increase was still observed for V32I; I54L, V11I and I50V also increased. Despite the increment in the mean number of mutations per patient between baseline and failure, in 21 patients (17.8%) at baseline and 36 (30.5%) at failure no PR mutation was detected. Different interpretation systems yielded different levels of DRV full resistance both at baseline and at failure. The HIV-DB system showed a low level of DRV full resistance, with a low increase at failure. In contrast, the Rega interpretation algorithm detected the highest proportion of full DRV resistant isolates and both Rega and ARNS algorithms detected significant differences in full DRV resistance between patients who subsequently failed versus those who responded to the DRV containing regimen. Rega and ARNS algorithms also showed a further increase in full resistance to DRV at failure, with ARNS that almost doubled the proportion of full resistant patients.

Keywords: Darunavir; Genotypic resistance; Protease inhibitors; Interpretation algorithms.

Articolo presente in – HAART and correlated pathologies n. 11

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Myalgia and creatine phosphokinase elevations in the HAART era: focus on Raltegravir

Raltegravir is the first HIV integrase inhibitor available in clinical practice for the treatment of HIV-infection in both naive and experienced patients. Randomized clinical trials have evidenced a good safety profile. However, grade III-IV creatine phosphokinase increases have been more frequently observed in patients receiving raltegravir in respect of comparator treatments and cases of rhabdomyolysis has been reported in the literature. In this article, we give an insight into the available data from clinical studies and case reports and possible pathogenetic mechanisms of raltegravir-related muscle toxicity.
Keywords: Raltegravir; Myalgia; Creatine phosphokinase; HAART

Articolo presente in – HAART and correlated pathologies n. 10

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