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.

Subscribe to this list via RSS Blog posts tagged in croi2015

The oral presentations during this session were excellent and should be available very soon.

They  included the Proud Study from the UK, On-demand PrEP with oral TDC-FTC in MSM - results of the ANRS Ipergay Trial, The Demonstration Project of PrEP and ART, Scale-up Pre-exposure Prophylaxis in San Francisco to impact HIV incidence, the FACTS 001 Phase 3 Trial of Pericoital Tenoforvir 1% gel for HIV Prevention in Women, the Effect of oral and gel Tenofovir on Genital HSV Shedding in immunocompetent Women, Injectable Hormonal Contraception Use and Women's Risk for HSV 2 Acquisition, Medical Male Circumcision of HIV -Infected Men reducing long term penile HIV shedding.

There are some exciting results from these studies which may impact what is happening in Australia.

From a sexual health point of view, I note with interest  the study where consistent DMPA use may increase women's risk of HSV2 acquisition. Obviously as pointed out, evaluation in larger populations with more frequent follow up is needed. It was also important that they pointed out that the issue of increased HIV and HSV-2 associated with DMPA needed to be weighed against benefits, reduced risk maternal mortality and unwanted pregnancy.

I intend to report back more on the session on Hormonal Contraception and HIV in Women.

It was also very useful to revisit yet again the issue of medical male circumcision where the study concerned noted penile shedding of HIV increasing at 1-2 weeks after medical circumcision in ART naive men but then, penile HIV shedding became significantly lower after wound healing later.  They concluded that suppressive ART decreased number of HIV shedding events and quantity of HIV shedding during would healing.  There was re-enforcemnt of the long term benefits of MC in HIV positive men reducing penile HIV shedding. However the importance of prevention of HIV transmission to partners during immediate post surgical period was emphasised. Initiating ART  at time of MC reduced male to female HIV transmission risk. Implications in Australia??? 

 

 

Tagged in: croi2015

Plenary 1, Presented by Raphael Landovitz is available for viewing http://www.croiwebcasts.org/

The speaker address a number of the common concerns associated with PrEP:

  • Decreased condome use, not being observed and high risk individuals self selecting for PrEP
  • Resistance not emerging (at least in early data)
  • Safety and adverse event (low and stop when PrEP stopped)
  • Supporting adherence, needs to be multifaceted
  • Optimal deployment is still to be determined

The big issue with all studies is that:

“Drugs don’t work in patients who don’t take them”

Interestingly Landovitz suggested that primary care providers are best placed to manage PrEP with their patients as they have long standing relationships and service negative patients. Specialists on the other hand see patients once they have HIV and may be in clinics which negative people avoid. He also suggested that generalists are least well equipped with information and education. This is a very interesting comment from the Australian perspective where so much HIV care happens in general practice.

He also suggested that optimal deployment will require a multi-pronged approach with information for health care providers, patients and from professional and clinical organisations and government providing clinical guidance. I recommend the talk, particularly for people wanting a comprehensive overview of contemporary PrEP science and implementation.

 

Tagged in: croi2015 PREP

Three exciting and anticipated papers were presented in the Oral session #1 this morning.

Sheena McCormack (abst 22LB)presented the PROUD study, which was designed to see if previous results could be achieved in a "real world setting", 539 people were randomised to 2 years once daily dosing with Truvada and 545 to a one year delayed therapy arm. The study was stopped late last year due inferiority in the deferred arm. There was an 86% reduction in transmission in the treatment arm and the three seroconversions is this group were probably infected or sero-converting at the outset. There were few side effects and the study population was at high risk of HIV.

Jean-Michel Molina presented IPERGAY (abst 23LB) this study looked at "on-demand PrEP" to see if efficacy achieved in macacques treated before and after exposure could be achieved in a real-world setting. The regimen was 2 pills 2 - 24 hrs before sex, one after sex and a further pill 24 hrs after the first dose. If there was more than one encounter the daily PrEP was prescribed. The results were also an 86% reduction in transmission and transmissions were again observed in participants who were either infected at the start or who had ceased taking drug. This is a very important study as it provides an option for people who have only limited high risk exposures. Side effects were minimal and stopped when the drug was ceased. Importantly from a cost effective standpoint. 18 pills per year were required to avert and infection and the average was 16 pills per month or 4 pills per week. This study will require close further scrutiny and could be a game changer.

Bob Grant (abs #25), from the San Francisco AIDS Foundation looked at what would be required to achieve transmission reduction targets. He found a combination of PrEP, increased treatment and testing together had the greatest impact. Importantly he reported that people who were taking PrEP were at high risk. Other were interested in taking it or interested but wanted more information. These people were eligible and given access had the potential to drive down infection rates.

The talks are available on line at http://www.croiwebcasts.org/ I really suggest considerable attention is given to this important session.

 

Tagged in: croi2015 PREP PROUD

Take- home messages for GPs with patients with HCV

1. There are much more effective Hep C drug regimes becoming available that produce high cure rates.

- in general terms the newer drug regimes, called Interferon-free Direct acting antivirals (DAAs), are achieving >95% cure rates in HCV genotype 1, and not much less in HIV co-infected patients.They are daily oral tablets as opposed to previous injections, better tolerated and require much shorter durations of treatment (usually 12wks) than previous regimes.

- HCV genotype 3 requires a different drug regime to Genotype 1. More recently treatment has changed from Pegylated Interferon and Ribavirin (PEG/INF/RBV) regimes to Sofosbuvir and Ribavirin for 24wks.

- in HIV co- infected patients on cART( combination anti-retroviral treatment) some regimes increase risk of renal toxicity and renal impairment and so regular renal monitoring, including  serum Creat, eGFR, Phosphate and urine Protein/ Creat Ratio, usually  on a 2-4 wkly basis is suggested in early treatment.

- remember to consider cART and HCV drug-drug interactions.

2. Diagnostic testing- "if you can't identify who your patient's are you can't treat them"

- in at risk patients test antibody to Hep C (Anti-HCV) and if positive then do HCV RNA , understanding that in early infection there is a sero-negative window where HCV RNA won't be present and hence you should repeat the test again a few weeks later.

- early diagnosis is even more important in order to enable early treatment with a view to preventing progression to cirrhosis, liver failure and cancer in those who develop chronic hepatitis but also importantly to prevent virus transmission to others ( treatment as prevention).

- remember that upto 50% of patients spontaneously clear the virus, most of those within 2-6 months.

3. In HCV/ HIV Co- infection liver disease is accelerated. There is a 3x risk of progression, which is also more rapid, to cirrhosis and decompensated liver disease.

4. Clinicians, including GPs should determine the severity of liver disease using clinical examination, laboratory tests- including Bilirubin, PT, INR, Albumin. In addition, other specialist investigations are used to determine hepatic fibrosis, include non- invasive imaging such as Fibroscan and direct serum biomarkers such as Fibrospect II. Liver biopsy is usually preserved for instances where there is discordance in the other results. Tools such as the Child- Pugh- Turcotte Score ( CTP) and the Model for End stage Liver disease (MELD) help to determine disease severity and to guide management decisions

5. Be aware that 5-7% of Child's A ( mild) cirrhotics progress to decompensated liver disease each year and hence regular review, at least 6 monthly, is recommended.

6. Screen for Hepatocarcinoma. Remember that in those with chronic disease and liver fibrosis cure does not remove the risk of hepatocarcinoma.

7. Consider organising Gastroscopy to screen for oesophageal varices.

Tagged in: croi2015

This workshop is being run adjacent CROI to facilitate participation. John Mellors stressed the ongoing importance of resistance testing and subsequent drug selection so as not to render treatment scale up futile. The focus of the meeting has also shifted to being largely focused on resistance as it impacts middle and low income settings. But there were considerable references back to high income countries, particularly in relation to resistance development in the context of PrEP.

The opening presentation from Shannon Hader reviewed the current position of resistance testing in the global environment of scale-up of ART and meeting the 90:90:90 testing, treatment and viral suppression targets. NOW was seen as the time where, through a shifting focus toward quality improvement and funding high impact programs, these targets might be realised by 2030. The contracting funding climate was what was seen as driving this need to get more bang from prevention and treatment buck.

Reducing cost from not unnecessarily changing to 2nd line therapy was seen as something resistance testing could inform. Likewise making sure that individuals starting PrEP are in fact HIV negative was seen as essential and something which could be determined by earlier use of viral load.

Neil Parkin questioned the constant need for gold standard, when such aims might mean that no change is achieved. This notion was revisited throughout both days. Neil was specifically looking at the efficacy of dry blood spot viral load and resistance testing. It was recognized the DBS uses a very small sample size, thus hindering detection at lower concentrations (largely because whole blood, unlike plasma, introduces other confounding material into the sample). But this was pitched against the collection and transport benefits of DBS sample collection. In some places conventional samples cannot be collected, transported or analysed due to cost and complexity.

Suzanne Crowe provided an overview of current point of care test development for CD4 and viral load. Suzanne defined PoCT not as the technology, but the extent to which a technology could be used easily and reliably in close proximity to the patient. Like a number of other speakers, Suzanne identified the need for training. And operator proficiency as one of the largest sources of performance variation between any of the tests. The ongoing need for CD4 in the context of viral load was discussed and CD4 was seen as having a continuing place if not a rosy future.

The later discussions focused on the clinical impact transmitted resistance and the role resistance might play in the roll-out of PrEP. Interesting here was the level of discussion about clinical and preventative applications. This was great to see as previously I have witnessed a big disconnect between the science and its implementation. Dan Kuritzke questioned whether transmitted AZT resistance really meant anything in the context of AZT-free treatment regimens. Likewise there was speculation about what was driving the identification of resistant virus among 13-19 yr old MSM in large scale surveillance studies from USA. This was thought to probably be behavioural and possibly associated with amphetamines and frequency of sex and sex partners.

Clearly resistance remains very important in guiding clinical choices and in mapping transmissions. Just how these two functions can dovetail was also topical. Is it ethical to link clusters and transmissions to programs to get people on treatment? And if you have information about where infections are occurring is it ethical to not use that information? Not having HIV transmission as a crime was seen as enabling this information to be used for clinical and scientific purposes, rather than punishment. Tulio de Oliveira identified this as a facilitator of clinical and surveillance programs in South Africa.

Many of the speakers from this workshop are also presenting at CROI so no doubt much more on this topic. 

 

Tagged in: croi2015

#worldhepatitisday: The word ‘hepatitis’ can prompt a lot of strong reactions. HEPAT = liver cells & ITIS = inflamm… https://t.co/4EAdA78aIO

ASHM ASHM