Download Dr Laura Waters Presentation

A BIT IF EVERYTHING!
A GENERAL UPDATE
Dr Laura Waters
Consultant
IMPORTANT DISCLAIMER
This presentation contains medical and pharmaceutical news, and data,
supplied for general information purposes only. The materials contained
within this presentation do not constitute medical or pharmaceutical
advice, which should only be sought from your own medical and
pharmaceutical advisers.
We are not responsible for any mistakes or deficiencies.
The material displayed within this presentation is provided without any
guarantees, conditions or warranties as to its accuracy.
If you need medical advice or are planning to change anything relating to
your healthcare or treatment please speak to your nurse or doctor before.
A bit if everything!
Laura Waters
Consultant
Content
•
•
•
•
•
•
•
•
•
Medical developments
New treatments
“Each speaker
Trials
gets max 15 mins
Clinic response to the present situation
- in order to keep it
New services
snappy”
Partner study
Proud study
A slide on Hep C
Do you want to mention Telemedicine?
Medical developments
(General Medicine)
• NICE guidelines for primary prevention of
cardiovascular disease
– Change in threshold for when to give a statin
– Controversial!
• Nicotine patches + other drugs are more effective
than either alone for smoking cessation
New HIV treatments
• Dolutegravir (Tivicay)
–
–
–
–
Integrase inhibitor
Licensed January 2014
Not (quite) available yet….
Draft NHSE guidance will probably be introduced with
no/minimal changes….
June 2014
Clinical Commissioning Policy:
Dolutegravir for treatment of HIV-1
in adults and adolescents
Month 2014
Reference: NHS ENGLAND B06/P/b
Some issues?
• “Approximately 10% of HIV positive people cannot
use the standard first line treatment (efavirenz)
because of these side effects and approximately
another 10% change treatment because of them up
to two years after starting”
7. Criteria for commissioning
Dolutegravir will be routinely commissioned in HIV-1 infected adults and
adolescents in the following clinical scenarios:
Patients unable to tolerate first line therapy
Patients who are not suitable for or who do not tolerate efavirenz based first line
therapy as agreed in the MDT (expected to be no more than 20% in the first two
years of treatment). Dolutegravir is a treatment option for this patient group.
Where used, this policy recommends use of dolutegravir with the lowest cost,
clinically indicated backbone. This is generally abacavir and lamivudine.
Patients failing treatment treatment and those with resistance
Dolutegravir is approved for use in these patients requiring an integrase inhibitor
due to recorded treatment failure or resistance:
In treatment experienced and Integrase inhibitor naïve patients at a dose
of 50mg daily.
In treatment experienced and integrase resistant patients at a dose of 50mg
twice daily.
Dolutegravir should be combined with at least two other anti-viral drugs to which the
virus is sensitive.
All patients for whom dolutegravir is considered a treatment option for failure and
resistance must be considered in an HIV specialist treatment multidisciplinary
Exclusions
• Patients switching to dolutegravir not referred to and
discussed in the MDT meeting or where decision not
recorded
• Patients stable on treatment should not be switched, no
published trial data
• Use of dolutegravir by providers not commissioned by
NHSE to provide HIV care and treatment services.
• An increase in price would require a review of this policy.
• Where clinicians consider switching outside these
circumstances, an Individual Funding Request may be
considered
What this means for YOU!
• Switches may be delayed while appropriate decisions
made
• The new drugs are probably not going to be used
first-line unless good reason
Other ‘new’ drugs
• Cobicistat (Tybost)
–
–
–
–
–
Alternative to ritonavir
‘Built-in’ booster in Stribild
Licensed to boost atazanavir and darunavir
Likely that we can only use if ritonavir problems
SAME DRUG INTERACTION ISSUES
• Tivicay
ABACAVIR +
LAMIVUDINE +
DOLUTEGRAVIR
Trials!
• 2 NRTI + boosted PI
• Randomised to swicth to 2 NRTI + dolutegravir:
– Immediately
– After 48 weeks
• ASK YOUR DOCTOR/NURSE/PHARMACIST ABOUT
TRIALS EACH TIME YOU VISIT!
Clinic response to current situation
• Times are tough!
• We are looking at everything we can to save money:
–
–
–
–
Staff (number, roles)
Tests
Drugs
Visits (frequency and type)
Appointments
• Where possible 6 monthly
• Where possible face to face only once a year
• In between:
–
–
–
–
Email
Phone
‘No news is good news’
(Specialist nurse)
Blood appointments
• You may be given a questionnaire
• This is then scanned and reviewed, along with your
results, at a ‘virtual’ appointment
Home delivery
• We know there have been problems!
• Still saves a lot of money
• Currently the reminders are not synced with your
appointments
• We are hoping to change this and there may be some
teething problems…bear with us!
Tests
• CD4!
– Only one a year if more than 350
– NEVER is more than 500….
PARTNER Study:
HIV transmission risk through condomless sex if the HIV positive
partner is on suppressive ART
• Aim:
– To evaluate the risk of within-couple HIV transmission (HT
and MSM) during periods where condoms are not used
consistently & the HIV+ partner is on suppressive ART
Rodger et al. CROI 2014. O153LB.
HIV negative partners: characteristics
MSM couples
(n=282)
Heterosexual couples (n=445)
M -ve (n=245)
W-ve (n=240)
40 (32-47)
45 (37-50)
40 (34-46)
1.5 (0.5-3.5)
2.7 (0.6-6.9)
3.5 (0.7-10.6)
1.1 (0.7-1.9)
1.5 (1.0-2.0)
1.5 (0.9-2.0)
Diagnosed with STI, %
16%
5%
6%
CL sex with other partners, %
34%
3%
4%
CL sex acts/year, median (IQR)
43 (18-79)
37 (14-77)
38 (14-71)
Estimated total no. CL sex acts
16,400
14,000
14,000
At study entry
Age, median (IQR)
Yrs CL sex, median (IQR)
During follow up
Years in study, median (IQR)
HIV positive partners: characteristics
MSM couples
(n=282)
Heterosexual couples (n=445)
M -ve (n=245)
W-ve (n=240)
42 (36-47)
40 (34-46)
45 (40-49)
5 (2-11)
7 (3-14)
10 (4-15)
Self-reported adherence ≥90%
97%
94%
94%
Self report undetectable VL, %
94%
86%
85%
CD4>350 cells/mm3, %
90%
88%
84%
Having missed ART for more
than 4 consecutive days, %
2%
7%
4%
Diagnosed with STI, %
16%
4%
5%
At study entry
Age, median (IQR)
Years on ART, median (IQR)
During follow up
Results
• No transmissions!
– Despite high levels of STI in HIV- MSM
• If HIV+ partner not on ART would have expected a
median of 86 transmissions at this interim 2 year
analysis
HIV transmission rate by sexual behaviour
reported by the negative partner
Rate of within couple
transmission (per 100 CYFU)
0
0.2 0.4 0.6 0.8
1
1.2
10 year risk (%) of within
couple transmission
0
2
Any sex
(CYFU=894)
Anal sex
(CYFU=374)
estimated rate/risk
95% confidence interval
4
6
8
10
PROUD
Pre-exposure Option for preventing HIV in
the UK: an open-label randomisation to an
immediate or Deferred offer
Aims of PROUD
• To determine ‘real-life’ efficacy
– When individuals know PrEP is effective
– Mimic clinic routine as much as possible
– Placebo alters behaviour, so non-placebo controls
• Randomised:
– Immediate PrEP vs deferred to 12m
• Measures net benefit, behaviour + biology:
– “...short daily diary…..monthly questionnaire and …. clinic
appointment every three months”
PrEP is coming….?
• PROUD Study = MSM study in UK GU clinics
• ‘High risk’ MSM randomised to:
– Immediate PrEP (Truvada – FDC of 2 NRTI)
– Delayed PrEP (12 months)
• DSMB advised stopping the deferred arm October
2014 due to high rates of PrEP efficacy
• PrEP licensed in the USA in 2012
• Not licensed in Europe
BHIVA statement
• “We welcome the news that we have made
significant progress in efforts to prevent HIV in men
who have sex with men, where ongoing transmission
in the UK remains unacceptably high, and look
forward to seeing the results when they are
available. BHIVA, along with other key stakeholders,
are working with NHS England to devise a policy to
consider the future availability of pre-exposure
prophylaxis, alongside existing measures to prevent
infection, within the NHS in the future.”
“On-demand” PrEP at sexual intercourse
reduces risk of infection
ANRS IPERGAY - France
“On-demand” Truvada
to be taken at the time of sexual intercourse
February 2012
> 400
MSM at
high risk of
HIV
infection
Double-blind,
randomised
All participants received a package of preventative measures:
• counselling
• repeated HIV testing
• screening & treatment for other STIs
• HBV vaccination
• condoms and gel
“On-demand” placebo
to be taken at the time of sexual intercourse
•
Un-blinded to counterpart DSMB of PROUD trial
– Data demonstrates a significant difference in incidence between each arm
The DSMB have recommended that all participants of IPERGAY now benefit
from “on-demand” Truvada as soon as possible
– Full results are expected in early in 2015
Press release. ANRS: A significant breakthrough in the fight against HIV/AIDS. 29 Oct 2014
Hepatitis C
• We are still seeing A LOT
• We have developed a leaflet
• We have written for DirtyBoyz
• We have updated our website
• Talk to staff!
• There are new drugs but guess what………….
….we can’t use them yet!! Example: sofosbuvir
Telemedicine
Thank you!
[email protected]
Which one?

Download Report