ASHM Report Back

Clinical posts from members and guests of the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) from various international medical and scientific conferences on HIV, AIDS, viral hepatitis, and sexual health.

HIV Co-infections, hepatitis B, hepatitis C and TB

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Professor Kate Dolan from the National Drug and Alcohol Research Centre, UNSW, presented data from their global systematic review of the HIV situation in prisons, which looked at imprisonment rates, HIV prevalence, HIV incidence, AIDS-related mortality, and services provided in prison, in the time period under observation from 2008 to 2013.

The review identified that 30 million individuals enter and leave prison per year, leading to the conclusion that good prisoner health is good public health, as any diseases contracted in prison, or made worse by poor conditions in custodial settings, returns to the community.

Drug dependence is a key factor in imprisonment in Australia, with 84% of people who inject drugs in Australia re-incarcerated within two years of release and the mean number of prison sentences sitting at 5. Whilst HIV prevalence is very low amongst Australian prisoners, transmission remains a risk and the prevalence of hepatitis B and hepatitis C has remained high.

Dr Fabienne Hariga, from the United Nations Office on Drugs and Crime then outlined a comprehensive package of 15 interventions for HIV prevention, treatment, and care in prisons, in particular looking at the introduction of needle and syringe program (NSP) into prisons, which she stated should be the number one priority.  

Dr Hariga outlined evidence from the evidence for action technical paper entitled Interventions to Address HIV in prisons: Needle and syringe programmes and decontamination strategies, which spoke to the feasibility and effectiveness of NSP in prison settings.

However, Dr Hariga conceded that current coverage of NSP in prisons is very low and many programs have not been sustainable to due strict controls implemented and a lack of confidentiality and anonymity, resulting in low uptake of the program by prisoners.

She concluded that a mixed model incorporating peer-based distribution, dispensing machines, and a health service, seems the best measure as part of a comprehensive package of interventions.

 

 

 

Tagged in: AIDS 2014 IAS2014

Away from the excitement created by Bill Clinton giving his Put Patient’s Health First to Improve Outcomes and Programme efficiency presentation today, a small group gathered for a Civil Society meeting on viral hepatitis called by the World Health Organisation (WHO). This informal meeting aimed to strengthen the engagement of civil society in WHO processes, enhance the dialogue on hepatitis-related work and build on the experiences of communities and groups living with, or affected b,y viral hepatitis undertaking advocacy work and providing services.  

Worldwide, between 130 and 170 million people are living with chronic hepatitis C and another 250 to 350 million are living with chronic hepatitis B—resulting in approximately 1.4 million deaths per year. Recognising the tremendous burden caused by viral hepatitis, this small event is one of a number of initiatives WHO is implementing, in order to build capacity and mobilise resources to respond to viral hepatitis. 

WHO established the Global Hepatitis Programme in 2010, following the adoption of resolution WHA63.18 (page 34) by the World Health Assembly, calling for a comprehensive approach to the prevention and control of viral hepatitis. Since then they have released:

and convened a Global Partners’ Meeting on Hepatitis to discuss the current status of the epidemic, levels of response in countries and future actions for enhanced hepatitis control worldwide. This meeting resulted in a "Call to action to scale up global hepatitis response" which puts pressure on the global community to increase access to prevention, diagnosis and treatment of viral hepatitis.

Furthermore, a new global resolution to promote a comprehensive response to viral hepatitis was adopted by the World Health Assembly in June 2014. WHA67.6 calls for enhanced action to improve equitable access to hepatitis prevention, diagnosis, and treatment and asks countries to develop comprehensive national hepatitis strategies.

At the event today the development of guidelines for hepatitis B and the development of a global strategy and plan for viral hepatitis which would include targets for the elimination of hepatitis B and C, were two of a number of initiatives currently being worked on by WHO demonstrating that momentum at global level is beginning to gather pace, but as we have learnt from HIV, there is a long road ahead, with much more collective action needed as we begin the journey.

 

Tagged in: AIDS 2014 IAS2014

While vaccination offers hope for a large decrease in hepatitis B (HBV) in the future, many people today are co-infected with HIV and HBV, particularly in regions where both diseases are common.

Gail Matthews from the Kirby Institute in her presentation today described a huge global burden of disease attributed to HIV and HBV and HIV/HBV co-infection. Discussing the management of HIV/HBV co-infection, Gail Matthews noted that HBV co-infection presents unique challenges, especially in resource-limited settings.

Lack of access to routine testing and monitoring is described as one of the major challenges, which include:

  • limited access to HBsAg testing, which means many co-infected individuals not identified pre-ART;
  • little understanding of natural history of co-infection; liver disease fibrosis assessment not readily available;
  • widespread absence of virological monitoring by HBV DNA testing.

Restricted access to Tenofovir in low and middle income countries, lack of routine screening of pregnant women for HBV and low coverage of universal infant vaccination in many countries are also described as the major challenges to the management of HIV/HBV co-infection.

Gail Matthews advocated for the changes at many levels including policy/advocacy, epidemiology, basic science and clinical research in order to overcome those challenges. These include: improved access to drugs; national testing policies; universal and birth dose vaccination; understanding of natural history of co-infection; management and incidence of flare; options for switch of treatment; and cure strategies.   

 

Tagged in: AIDS 2014 IAS2014

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In the Hepatitis Co-infection session today, Sanjay Bhagani from the Royal Free Hospital, London described co-infection with hepatitis C for a person living with HIV as “double trouble” for the liver.

He began by looking at the D:A:D study which examined the causes of death in 49,734 HIV-infected patients followed in the period from 1999 to 2011. In this study liver-related diseases were found to be a frequent cause of non-AIDS related death, responsible for 13% of deaths.

A second study showed that persons co-infected with HIV and HCV have liver fibrosis stages similar to those without HIV who are nearly a decade older, with progression shown to be faster even when controlling for alcohol and other co-morbidities. Bhagani also demonstrated that hepatotoxicity was more common in co-infected patients even with modern HAART.

It was not all bad news, however, with the era of Direct Acting Antiviral (DAA) based therapy now a reality. Bhagani outlined results from a number of trials looking at interferon-sparing and interferon-free therapies, which revealed similar SVR rates in co-infected patients as in mono-infected patients.

Such results have meant the EASL recommendations on the treatment of hepatitis C released in April 2014 state that the same treatment regimens can be used in HIV/HCV patients as in patients without HIV infection, as the virological results of therapy are identical. Bhagani advocated for the need for an improved cascade of care and access to treatment for people living with HIV and HCV, due to the aggressive, multi-system impact of co-infection.

 

 

Tagged in: AIDS 2014 IAS2014

The inaugural Hepatitis Session was held on the morning of the opening day of the meeting. This was held in the main hall and was almost full, reflecting the increased interest by the Infectious Diseases community in the rapidly advancing direct acting antivirals for the treatment of both HIV/HCV co-infection and HCV mono-infection. 

In the afternoon, a symposium on HCV was held, with international experts discussing areas of unmet need

Press release from CROI 

1. 12 wks of ABT-450r nonnucl inhibitor and ribavirin achieved SVR24 in >90% treatment-naïve HCV GT1 patients and 47% prior nonresponders. Lawtiz E, et al. A38

This presentation included final results from both the PILOT and CO-PILOT  Phase II studies, where all patients with HCV mono-infection received 12 weeks combination therapy with the ritonivir-boosted protease inhibitor, ABT-450, ribavirin and one of two non-nucleoside NS5B polymerase inhibitors (ABT-072 and later ABT-333 In Cohorts 1, 2 and 3, 44/44 treatment naïve patients achieved end-of-trearment response, of whom 2 relapsed within the first 12 weeks post-treatment, 3 more relapsed between 12 and 24 weeks post and 1 between 24 and 48 weeks post. Late relapses (more than 12 weeks post-treatment) is not seen following conventional treatment with PEG/RBV or PI/PEG/RBV and this observation emphasizes the need for longer post-treatment follow-up. This regimen was less effective in treatment-experienced patients. In Cohort 4, only 8/17 patients achieved SVR. In view of these suboptimal results, Abbott has added a third DAA, the NS5A inhibitor ABT-267, to the combination of ABT-450/r and ABT-333, in order to prevent post-treatment relapse. Current Phase III studies of this regimen are underway.

2. STARTVerso 4: High Rates of Early Virologic Response in Hepatitis C Virus Genotype 1/HIV Co-infected Patients Treated with Faldaprevir + Pegylated Interferon and Ribavirin. Dieterich D, et al. LB40

Faldaprevir is an oral second generation protease inhibitor, which is administered once daily with no food effect and no need for ritonivir boosting.  Interim study results from STARTversoTM 4 presented today at CROI+ show that 84 percent of hepatitis C (HCV) patients also infected with HIV had undetectable levels of HCV at week 12 of treatment with faldaprevir (BI 201335) combined with pegylated interferon and ribavirin (PegIFN/RBV), regardless of whether they were treatment-naïve or relapsed after prior treatment for HCV. Patients who achieved early treatment success may be eligible for 24 weeks rather than the standard 48 weeks of treatment with PegIFN/RBV. The most frequent adverse events were nausea (37%), fatigue (33%), diarrhoea (27%), headache (23%), and weakness (22%), similar safety results to those observed in HCV mono-infected treatment-naïve patients in prior faldaprevir clinical studies.

3. Telaprevir for Acute Hepatitis C Virus in HIV+ Men both Shortens Treatment and Improves Outcome. Fierer D. LB156

Pre-existing HIV infection reduced the rate of spontaneous clearance of HCV following acute HCV infection and also reduces the rate of successful eradication following interferon-based treatment. In this open-labeled study, 18 HIV+ patients with acute HCV infection received 12 weeks triple therapy with telaprevir- based triple therapy and 15 (83%) achieved SVR (compared to around 60% in historical controls treated with 48 weeks PEG/RBV). Although a small study, the higher SVR rate and shorter duration would support the future use of triple therapy for all cases of acute HCV superinfection in HIV+ patients.   However, caution is needed with direct drug interactions with anti-HIV medications

4. ANRS-HC27 BocepreVIH Interim Analysis: High Early Virologic Response with Boceprevir + Pegylated Interferon + Ribivirin in Hepatitis C Virus/HIV Co-infected Patients with Previous Failure to Pegylated Interferon + Ribavirin. Poizot-Martin E, et al. A37

Preliminary on-treatment results were presented from this Phase II study of boceprevir-based triple therapy in HIV/HCV coinfected patients, who have failed to respond to prior PEG/RBV. Of 64 patients who commenced treatment, 12 stopped within 12 weeks (1 discontinued for personal reasons, 4 for adverse events and 7 for treatment failure). The remaining 52 patients all had undetectable HCV RNA at week 12 and week 16.

The prior response to PEG/RBV determined on-treatment response to boceprevir-based triple therapy: HCV RNA was undetectable after 16 weeks in 90% prior responder-relapsers, 61% in partial responders and 38% in prior Null responders.

The early on-treatment virologic response rates observed in this study are similar to those achieved with boceprevir in HCV mono-infection but post-treatment responses are awaited.

5. High Early Virological Response with Telaprevir-Pegylated-Interferon-Ribavirin in Treatment-experienced Hepatitis C Virus Genotype 1/HIV Co-infected Patients: ANRS HC26 TelapreVIH Study. Cotte L, et al. A36

Preliminary on-treatment results were presented from this Phase II study of telaprevir-based triple therapy in HIV/HCV coinfected patients, who have failed to respond to prior PEG/RBV. Of 69 patients who commenced treatment, 8 stopped within 12 weeks (1 discontinued for treatment failure and 7 for adverse effects). The remaining 61 patients all had undetectable HCV RNA at week 12 and week 16.

68/69 patients had at least one adverse event, of which the most common was anaemia requiring intervention (41/69 patients).

The early on-treatment virologic response rates observed in this study are similar to those achieved with telaprevir in HCV mono-infection but post-treatment responses are awaited.

6. Suppression of Viral Load through 4 Weeks Post-Treatment Results of a Once-daily Regimen of Simeprevir + Sofosbuvir with or without Ribavirin in Hepatitis C Virus GT 1 Null Responders. Lawitz E, et al. LB155

These are the long awaited results from an exciting Phase II study combining two of the most potent direct acting antivirals currently in clinical development – the nucleotide polymerase inhibitor sofosbuvir (GS-7977) and the protease inhibitor simeprevir (TMC-435), in the most difficult-to-treat patient population – those with HCV GT-1 infection, who had Null response to prior treatment with PEG/RBV. The assumption was that the NUC would prevent the emergence of resistance to the protease inhibitors. 12 weeks combination sofosbuvir/simeprevir achieved SVR4 in 26/27 patients whilst 12 weeks combination sofosbuvir/simeprevir/ribavirin achieved SVR4 in 13/14 patients. Additional arms of 24 weeks combination sofosbuvir/simeprevir±ribavirin had similar SVR but higher rates of AEs and treatment discontinuation.

The authors concluded that the combination sofosbuvir/simeprevir for 12 weeks was highly effective and did not require the addition of ribavirin or extension to 24 weeks.

Tagged in: CROI2013

Please join us for a memorial event celebrating the life of one of Australia’s leading HIV advocates, Levinia Crook… https://t.co/N7dof5xaGa

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