Walking around Vancouver you can't help noticing the shops selling medicinal cannabis - the big cartoon weed pictures are so obvious!  So it was interesting to hear about the response to the IVDU problem here, and in yesterday's plenary Dr Evan Wood gave a summary of the main issues and how local authorities have worked to address them.

Dr Wood is a Professor of Medicine with an interest in HIV and drug addiction. He has been researching the impact of medically supervised safer injecting sites in reducing drug-related harm while increasing access to detox services for drug users. His research was the first to clearly demonstrate the positive impacts of safer injecting facilities for injecting drug users in Canada. This research has been instrumental in the development and continuation of Insite, a supervised injecting site in Vancouver that has saved many lives.  Dr. Wood pointed out that stigmatization of drug addiction is a major barrier, and he has been a voice for evidence based policies rather than ones based on negative perceptions of drug use.

He described the 4 Pillar approach to tackling drug use:

1. Prevention
2. Treatment
3. Enforcement
4. Harm Reduction

Vancouver had an explosion in HIV cases amongst its IVDU population in the 1990's, which at its height saw a fatal overdose occurring every day.  This prompted the city authorities to use a new approach.

The strategies employed included:

• sterile needle provision
• supervised safer injecting facilities (which prevents needle sharing)
• methadone programs and other OSTs
• treatment as prevention

Unfortunately, the 4 Pillars philosophy is not shared by the Canadian federal government, and a quick google search reveals that there is still much debate over the issue.  This is despite Dr Wood's claims that new HIV diagnoses in the IVDU community in Vancouver have dropped by 90% since the actions were implemented.

In stark contrast, at today's plenary I caught the last 10 minutes of the overview of the HIV situation in the Russian Federation, Eastern Europe and Central Asia, and was dismayed to hear that the situation there with respect to HIV in the IVDU population is very serious, largely driven by unsafe injecting although heterosexual transmission is also increasing. 

There are very few structured and recognized civil society and community-based organizations in most countries in the region.

The Russian Federation has some of the world's highest incarceration rates, with prisoners often waiting in overcrowded jails for months before trial.  Unsafe injection use, corrupt prison staff and high rates of unsafe sex and TB prevail.

Drug policies rely heavily on prohibition law enforcement, and methadone is illegal.

It is hard to see how a focused approach to the problem can be achieved under such circumstances.

 

 

 

 

At this morning's IAS plenary Professor Greg Dore from the Kirby Institute and St Vincent's Hospital in Sydney gave an excellent presentation on the exciting treatment options soon to become available for Hep C, and described some studies he is currently involved in.

The development of interferon-free HCV therapy provides one of the major advances in clinical medicine in recent decades. 

Major recent developments include:

• There are now several highly effective IFN-free DAA regimens for genotype 1
• HIV has no impact on HCV treatment outcomes
• HCV resistance testing is of limited clinical relevance
• Some treatment individualization may still be required (e.g. cirrhosis)
• Decompensated cirrhosis is reversible, but not always
• Shorter duration (6-8 weeks) pangenotypic regimens are in development

In the treatment of GT1, the presence of resistance mutation Q80K may compromise treatment response to simeprivir/sofosbuvir if cirrhosis is present, but treatment outcomes improve if the treatment period is increased from 12 to 24 weeks.

Treatment of GT3 will likely need combination with one of the NS5A inhibitors.

Professor Dore described "perfectovir", the ultimate therapeutic agent for Hep C, the holy grail which the pharmaceutical companies are striving to develop.  The attributes of "perfectovir" would be:

• Extremely high efficacy
• Well tolerated
• Once daily dosing
• Pangenotypic
• Short duration (6-8 weeks)
• Affordable

The cost of these new DAAs is the major barrier.  Broadened access to IFN-free HCV therapy would provide the foundation for HCV treatment as prevention.  This could be looked at in high risk populations such as incarcerated people and people on opioid substitution therapy programs.

Professor Dore went on to describe 2 interesting studies.

The STOPC study looks at HCV treatment as prevention in 5 Australian prisons.  The primary objective is to evaluate the impact of a rapid scale-up of IFN-free HCV treatment on HCV transmission.  The primary endpoint will be a change in HCV incidence from pre- to post- scale-up of IFN-free HCV treatment.  The baseline HCV prevalence in this community is 24%.

The CEASE study looks at co-infected populations, and again evaluates the impact of a rapid scale-up of IFN-free HCV therapy on HCV transmission among people with HIV, with the primary endpoint again being a change in incidence from pre- to post- scale-up.  This study is very much underpinned by the March 2015 recommendations of the Australian PBAC for use of the new DAAs sofosbuvir, ledipasvir and daclatasvir, with no restrictions based on stage of liver disease or injecting drug use.  The hope is that primary care S100 prescribers who currently manage co-infected HIV patients will start prescribing for HCV, and ultimately be able to provide this treatment for HCV mono-infected patients.

In summary, the arguments for IFN-free therapy access for all as presented by Professor Dore are:

• IFN-free therapy is an enormous advance in therapy
• HCV-specific QOL impairment in early disease, reversible
• Potential HCV treatment as prevention benefits
• Non-treatment = ongoing monitoring, potentially for decades
• Drug price curve will continue downwards
• Ability to cure empowering for entire hepatitis C sector

 

 

 

I've just attended the presentation of the findings from the START trial (the Strategic Timing of Antiretroviral Treatment), presented by the principal investigator Dr Jens Lundgren from Denmark.

The message conveyed was that the evidence is now clear that commencing treatment at diagnosis of HIV confers definite advantages to the individual regardless of their CD4 count.

The study randomized 4685 people to go onto immediate ART or to delay treatment until CD4 was below 350.

The primary endpoint was serious AIDS and non-AIDS events or death.

It was a multi-centre trial, with 35% of participants from Europe, 25% from Latin America, 21% from Africa, 11% from North America, 8% from Asia and 2% from Australia.  Of the participants 27% were female, 30% were black, 55% acquired HIV through MSM, 38% heterosexual transmission, and 32% were smokers.  The median time since diagnosis was 1 year, the median CD4 was 650 and median viral load 12,000.

The trial was terminated early due to a clear advantage in the early treatment arm.

It was interesting to see that there was no difference in reported treatment-related adverse events in the two groups; in other words it did not appear that starting treatment earlier resulted in extra adverse events for those patients.

There was a sub analysis of the outcomes at different CD4 counts, and it showed that there was still an advantage to starting treatment early even if CD4 counts were above 800.  I would have liked to see more discussion about this, as the key question for many of our patients is about starting therapy with high CD4 counts, and the slides presenting this data were rather difficult to interpret for a non-statistician like me.

The room was abuzz with excitement when panel member Gottfried Hirnschall from WHO announced that the new guidelines being released by WHO in September will be recommending treatment for all people with HIV at all ages regardless of CD4 count.

The ensuing panel discussion was less of a discussion and more of a series of statements, mostly focusing on what the implications are for the future, and what the impediments are to global implementation of early treatment.