When to Start Therapy The Patients Viewpoint

1
When to Start Therapy?The Patients Viewpoint

• Gus Cairns
• NAM Publications
• Patient Rep, BHIVA Executive Committee
• EATG

2
Contents

• Background guidelines change
• What do we tell patients?
• Readiness
• Swiss HIV Cohort study
• Barriers to starting
• EACS Algorithm
• NAM Study
• Quantitative Findings
• Qualitative Findings
• Themes and Conclusions

3
Background guidelines change

• Post-SMART and other studies, guidelines on when
  to start therapy have swung back to starting at
  350 CD4 cells/mm3
• BHIVA The initiation of therapy should be
  recommended in all patients with a CD4 count of
  
• CDC Antiretroviral therapy should be initiated
  in patients with a history of an AIDS-defining
  illness or with a CD4 T-cell count
  cells/mm3.
• EACS CD4 201-350 treatment recommended

4
Most patients start later

• BHIVA audit 2005
• 1/3 of patients were diagnosed with CD4s
• 2/3 of patients started therapy with CD4s
• Swiss HIV Cohort
• Only 30 of 1730 naive patients with CD4s 200 at
  2nd cohort visit started ARVs with CD4s 200

Sullivan AK et al. Newly diagnosed HIV
infections review in UK and Ireland. BMJ
330(7503)1301-2. 2005. Wolbers M et al. Delayed
diagnosis of HIV infection and late initiation of
antiretroviral therapy in the Swiss HIV Cohort
Study. HIV Medicine 9(6) 397-405. 2008.
5
Some of this is late diagnosisCD4 count at
diagnosis, UK
6
Why have CD4 criteria at all? Why not just when
patients ready?

• UK CHIC Cohort relative risk of AIDS for people
  with CD4 count
• Over 650 1.0
• 500-649 1.55
• 350-499 2.49
• 200-349 4.91

The UK Collaborative HIV Cohort (UK CHIC) Study
Steering Committee. Rate of AIDS disease or death
in HIV-infected antiretroviral therapy-naïve
individuals with high CD4 cell count. AIDS 21
1717 1721, 2007.
7
What is readiness?

• All guidelines depend on concept of readiness
• BHIVA with CD4s 200-250, Treat as soon as
  possible when patient ready
• EACS Time should be taken to prepare the
  patient, in order to optimise compliance and
  adherence
• US (CDC) The necessity for patient
  adherence...should be discussed in depth between
  the patient and clinician. Potential
  barriers...should be identified and addressed
  before therapy is initiated.
• How is this determined?
• What is ready?
• How much time to prepare the patient?
• How do you establish that a barrier has been
  addressed?
• Does this vary according to disease stage?
• Are some patients never ready?
• Are some ready before their doctor?
• Presupposes a partnership between patient and
  doctor

8
Swiss HIV Cohort readiness study

• The readiness of HIV-infected individuals to
  start or change therapy has been poorly
  investigated so far.
• Study took 75 patients eligible to start or
  change therapy (due to guideline criteria or
  patient wish) at 3 clinics
• 62 said they would start or change, 13 decided
  not to
• 54 eventually did 21ended up not
  starting/changing (35 fewer than estimate)

Fehr J et al. Starting or changing therapy a
prospective study exploring antiretroviral
decision-making. Infection 33249-256. 2005.
9
Swiss HIV Cohort study 2

• Potential starters with depression very
  significantly less likely to start (pgroup of only 34)
• Trends towards people with anxiety and lower QoL
  also being less likely to start
• Patients who made decision mainly by myself
  less likely to start/change. Decision to
  start/change mainly seen as shared decision
• Both patients and doctors too optimistic about
  who would start. Out of those originally assessed
  for starting
• Doctors predicted 2 wouldnt start and 5 not sure
• 2 patients predicted they wouldnt start and 6
  not sure
• In the end 13 didnt start

10
Swiss HIV Cohort study 3

• Information is not the issue 97 said theyd had
  enough info to make decision
• Reasons not to start/change include
• I fear the side effects
• I feel healthy
• I need more time
• I am about to travel
• I will wait for better drugs
• I know other HIV people who have had bad
  experiences
• My partner advised me not to start/change

11
Result EACS Starting Algorithm
See http//www.eacs.eu/Guidelines_Livret/index.h
tm
12
NAM Study of patient attitudes to treatment

• Internet Questionnaire on www.aidsmap.com
• English, Spanish, French, Portuguese
• 12 September 06 November 2008
• Asked (among other things)
• Whether respondent was in a country where
  treatment is accessible
• Therapy status naive/started/stopped
• Sources of information/decision making
• Disclosure
• Knowledge of current guidelines
• If naive when would they start?
• If started side effects etc
• Main concerns about starting/resuming treatment
• Main concerns if on treatment
• Open Qs What helps with adherence other
  comments

13
NAM Study

• 2189 respondents
• 1547 (71) in drop-down menu of countries with
  open access i.e. Europe, N America,
  Australasia, Japan
• Should we have differentiated between
  limited-access and open-access countries?
• We only gathered demographic data on open-access
  countries
• 55.5 of people in limited access countries were
  in fact on treatment
• A number of people in open access countries
  esp. USA pointed out they had no or limited
  treatment access
• 70 of responses in English, 16 Spanish, 12
  French, 2 Portuguese

14
Countries
15
Demographics (open-access countries only)

• Ave age 35-40
• 10 female in English questionnaire, 24 in
  French and Spanish, 20 Portuguese
• 8 with children in English questionnaire, 18
  Spanish, 22 French, 15 Portuguese
• 88 described themselves as white

16
Sexuality
17
Treatment status

• Including estimated nos. in limited-access
  countries

• Open-access countries only

18
CD4 count, treatment-naive

• In treatment naive people in developed countries
• Only 11 in English-language questionnaire had a
  CD4 count under 300
• Only 4 in Spanish questionnaire
• None in French or Portuguese questionnaires

19
CD4 count guidelines

• All respondents were asked Did you know that
  the recommended time to start treatment is now
  when your CD4 count is around 350 cells/mm3?

20
When would you start? (Treatment-naive)

• Drug-naive patients in developed countries were
  asked if they had a target CD4 count to start
  therapy.
• 47 would start when clinic advises. Of the
  rest
• 12 said 400
• 25 said 350
• So at least 37 would wish to start at 350 or
  above
• 8 said 300
• 3 said 250
• 4 said 200
• So at least 15 would wish to start at 300 or
  lower

21
When did you start? (Treatment-experienced)

• Of developed-country respondents on ART
• 50 started treatment since 2004
• 31 in last two years
• 17 in last year
• 17 pre-1997

22
At what CD4 count?(Treatment-experienced)
23
CONCERNS 1

• Proportion of all respondents who had major or
  significant concerns before starting or
  restarting therapy

24
CONCERNS 2
25
Concerns 3 Started, pre-treatmentNB Naive
patients yet to start had virtually the same
proportions of concerns
26
Concerns 4started, post-treatment
27
Side effects frequency
28
Side effects severityPercentage reporting a
serious long term effect on my quality of life
29
What helps with adherence?Answers to the
question please use this space to tell us about
things that have helped you in taking HIV
treatment

• 355 replies out of 1424 respondents in English
  questionnaire (25)
• Terms frequently used
• Alarm (48 mentions, 19) most often, mobile
  phone alarm
• Pill box (32 mentions, 9.5)
• Atripla (13 mentions) or one pill once a day
  (12 mentions) (Together, 8)
• Support from partner or family (22 mentions)
• Other mentions of once a day (18 mentions)
• Routine (17 mentions)

30
What helps with adherence? Quotes

• Knowing that I live each day to see my children
  grow up
• Hope that one day a cure will be found and that
  this disfiguring, sickening and toxic treatment
  is only a bridge to keep me alive
• Most importantly, a consultant that worked with
  me over years to get the right combination with
  the fewest side effects
• Taking meds is my way of saying I want to live
  and not give up, even though my partner of 25
  years has passed away
• Telling my daughter I have to take pills because
  of the menopause, which enables me to take them
  without disclosure
• Drinking less, having a job, having things to
  live for
• I have started and stopped my meds tooo many
  times and my doctor says they will run out of
  cocktails, so I have to get my act together
• A small plastic bullet which holds my Atripla,
  it rattles with my body movement from time to
  time and reminds me if I havent taken the pill.
• I dont want to die now my kids are so young. Who
  will look after them if I am not responsible
  enough to take my medication?

31
Other commentsAnswers to the question Please
use this space to make any comments about the
topics raised in this survey (365 answers)

• Topic cluster one long term survivors
• I started therapy in 1993 and many of the
  questions dont apply to me, as you did what the
  doctors told you and hoped to stay alive
• We took what was available, and there was
  no/little choice
• Ive had HIV 20-plus years, did not start meds
  till I had 26 cells, I now have 600. I have
  dedicated my life to health and freeing myself
  from stress.
• I had to answer no access to treatment when you
  asked why didnt start because I was diagnosed
  in 1986. There are some of us still around you
  know!
• When my CD4 counts fell below 200, there was
  only AZT available, and it was killing as many
  people as it was saving, so declined the offer
• When I first became sick AZT was the only drug.
  That colored my decision to wait for other
  treatment.
• I am 82 and have been HIV for 20 years
• (Another respondent answered I was diagnosed
  today)

32
Other commentsCluster two doctor and patient

• I had an excellent consultant who knew everything
  about ne but she was in a temporary post and
  everyone in the clinic was shocked when she was
  not employed permanently. This made me lose
  confidence in my clinic
• Most women I know feel their doctors do not go
  into enough depth with them
• The nursing staff have been much more helpful and
  informative than the doctor. I do not understand
  what the doctor has said so ask the nurse after
  seeing the doctor
• I recently changed clinics. It was very stressful
  and felt like starting all over again
• I have a great working relationship with my
  doctor and his team. Im in two clinical trials,
  the doctors talk to each other and I feel very
  well informed
• My ID doctor only wants to concentrate on HIV. I
  have high lipids, blood pressure, depression,
  unexplained back pain and he expects my GP to
  monitor them. Too many doctors, too many co-pays,
  too many things to track (US patient)
• I feel isolated. I was told my bloods would be
  done every month for the first 3 months, but they
  were only done once and the results were through
  the nurse rather than the doctor

33
Other commentsCluster three side effects

• I am a nurse and expected to be able to handle a
  lot of my side effects but it scared me when the
  drugs made me feel out of control. No health
  professional said it would be that bad.
• Im 65 and in the last 6 months have started to
  suffer from arthritis in the hands, no one can
  tell me if this is age or the AZT Ive been on
  for the last 3 years
• You seemed to assume people would stop once. I
  have started and stopped 6-7 times due to side
  effects
• I suffer from lipodystrophy (LD) and fatigue
  possibly side effects from a drug regime never
  disclosed till too late. I suffer from severe
  depression but accept this is maybe the lesser of
  two evils
• Despite the success of HAART the stigma of LD has
  a devastating effect. Appearance and its
  psychology could be better handled in the overall
  literature
• I am very scared of the side-effects especially
  this body-changing lipoatrophy (recent starter)
• We dont easily get drugs of choice in the
  developed world. I got kidney problems, felt
  bloated, lost all my hair, terrible pain from
  ingrown toenails. When I moved from Africa to
  London my doctor took one look and took me off
  Crixivan. I immediately got better.
• After a bad reaction and change of meds (I was
  one of the unlucky ones with SJS) I got used to
  the routine and now its just part of life, far
  easier than I imagined.

34
Other commentsCluster four disclosure, stigma,
isolation

• Taking meds feels like a rubber stamp on my
  diagnosis once I say I am taking ARVs then I
  have disclosed my status
• With the drugs, people cannot see a difference
  between me and the general population. Lessens
  stigma and encourages people to get tested
• In Iceland where I am, all the patients personal
  data is included on the prescription. There is
  one person in the north, one in the west,
  everyone knows who they are
• There is no network or meeting place mediated by
  clinics where HIV can meet, socialise etc.
  Gaydar is a disaster most people are just after
  sex
• I live in Granada, Spain. Theres not a special
  HIV hospital and Im terrified of starting ARVs
  because the doctors here seem to decide on what
  ARVs to give according to what the hospital has
  say theyre all the same
• I live in a rural town in Spain. Treatment is
  faultless but my consultant thinks theres no
  such things as side effects and treats my
  efavirenz effects with a shrug
• I think there are long term issues of trust that
  have never gone away. I am extremely secretive of
  my diagnosis.

35
Other commentsCluster five access and cost

• In the USA HIV robs many of living a life. I was
  a well paid professional but now if I were to
  work I would lose my social security disability
  and Medicare. The USA is so quick to help the
  rest of the world while many HIV US citizens lie
  on sidewalks.
• It was a waste of time going the prevention way
  in here in Africa. Since an HIV test was a death
  sentence PLWHAs started to wilfully infect
  others. I am one of the lucky ones but 400,000
  people need ARVs in my country.
• This survey should bring to light the daily
  conditions in which people struggle to make a
  living, here in Malawi the centres are highly
  congested and there are long waiting lists for
  people to get started on therapy.
• Although a UK citizen I have always lived and
  worked abroad and dont want to be forced to
  retire to the UK
• This survey only seems to be interested in the
  countries on the list. In my country you only get
  treatment if your CD4 count is under 200 if
  youre lucky.
• I wish the WHO could make it a law that people
  must be started at 350. Im still not on
  treatment here in Africa having been diagnosed
  with HIV and TB for 13 years and seeking ARVs for
  ten.
• I recently lost my job and my Atripla copayment
  is over 300 a month. I am worried sick about
  this (US patient)
• Maybe you should get PEPFAR to conduct a similar
  survey in Africa!

36
Other commentsCluster six mental health

• You did not list depression as a reason for not
  staying on meds. I am now much more consistent in
  taking my meds since I started on
  anti-anxiety/depression meds
• One thing you didnt mention that could delay
  treatment was fear. I waited almost 5 years to
  tell anyone or seek treatment I had zero
  T-cells. Now I have over 700.
• There should be more psychological support for
  people with HIV, especially the newly diagnosed
• I am starting therapy next week and actually feel
  relieved as I have been thinking and talking
  about it for a long time. One of the stresses has
  been the constant readiness and then anticlimax
  of not starting.
• I rely on myself. Doctors primary concern is
  making sure your heart continues to beat and not
  your quality of life. I Have lost all trust in
  them
• No question allowed for the patients
  decision-making to be influenced by a lack of
  desire to live a longer life as HIV positive.
  This was my own reason for initially refusing
  treatment, even when my CD4 count was below 200.

37
What we already know helps

• Rob Horne et al, 2002
• Decision to start characterised by
• recognising personal need for HAART
• anticipating benefits from taking HAART
• having addressed concerns about taking HAART
• believing personal circumstances to be conducive
  to starting treatment
• being influenced by other people's experiences of
  HIV and HAART
• being in accordance with medical recommendations
  to start.
• Decision not to start characterised by
• doubting personal need for HAART
• having concerns about taking HAART
• having previous negative experience of HAART
• holding negative beliefs about medicines in
  general
• requiring autonomy in the treatment decision.

Cooper V, Horne R et al. Perceptions of highly
active antiretroviral therapy (HAART) among HIV
positive men who have been recommended treatment.
Intl ads Conference, Barcelona, 2002. Abstract
MoPeB3253.
38
What these studies add

• Importance of assessing depression BEFORE
  starting ART
• Influence of previous experiences of ARVs in
  friends/partners
• Fear of side effects still extremely important,
  especially lipodystrophy
• The simplest things help most with adherence
  alarms, pill boxes, once-a-day regimes
• Partnership with healthcare provider (of various
  types) as important than ever

39
Thanks to...

• Keith Alcorn, NAM
• Jan Fehr, University Hospital, Basel
• David Haerry, EATG
• Ian Weller