Who hiv 2012.29_eng

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Who hiv 2012.29_eng

  1. 1.   WHO/HIV/2012.29           Annex  8:  Values  and  Preferences  report       Based  on  interviews  with  community  members  affected  by   and  providers  working  on  viral  hepatitis                         Background  paper  for  WHO  consultation  on  viral  hepatitis  prevention,   surveillance  and  treatment  
  2. 2. 2 Acronyms  and  Abbreviations     3TC     lamivudine   ART     antiretroviral  therapy   ARV     antiretroviral     AZT       zidovudine   FTC     Emtricitabine   HBV     hepatitis  B  virus   HCV     hepatitis  C  virus   HDV     hepatitis  D  virus   HIV     human  immunodeficiency  virus   LDSS     low  dead  space  syringe   NGO     non-­‐governmental  organization   NSP     needle  and  syringe  programs   OST     opioid  substitution  therapy   PLHIV     persons  living  with  HIV   PWID     people  who  inject  drugs   STI     sexually  transmitted  infections   TDF     tenofavir   WHO     World  Health  Organization  
  3. 3. 3   Background  Information     It  is  estimated  that  350  million  people  are  chronically  infected  with  Hepatitis  B  virus  (HBV);  and  130-­‐ 170   million   people   are   chronically   infected   with   Hepatitis   C   virus   (HCV).1,2   Co-­‐infection   with   HBV   and/or  HCV  with  HIV  is  increasingly  recognized  as  a  major  public  health  problem.  In  certain  regions,   up  to  10%  of  all  people  living  with  HIV  (PLHIV)  are  co-­‐infected  with  chronic  hepatitis  B;  and  25%  are   co-­‐infected  with  chronic  hepatitis  C.3     Viral  hepatitis  B  and  C  disproportionally  affect  people  who  inject  drugs  (PWID)  as  a  result  of  unsafe   injection  practices.  It  is  estimated  that  1.1  million  PWID  have  HBV  and  10  million  have  HCV.4    The   largest   populations   are   in   Eastern   Europe,   East   Asia   and   South-­‐East   Asia.   Although   HBV   is   preventable   by   vaccination,   the   rate   of   vaccination   among   people   who   inject   drugs   is   low.   In   addition,  although  both  chronic  HBV  and  HCV  can  be  effectively  treated  and,  sometimes  cured,  very   few   PWID   access   treatment   because   of   the   high   cost   and   other   barriers   to   accessing   the   health   system.         Liver   disease   is   currently   one   of   the   leading   causes   of   morbidity   and   mortality   in   HIV-­‐infected   populations,  particularly  in  settings  where  antiretroviral  therapy  (ART)  access  is  being  expanded.  It  is   well  established  that  HIV  has  a  negative  impact  on  the  natural  history  of  HBV  and  HCV,  with  a  higher   rate  of  viral  persistence,  and  more  rapid  progression  to  fibrosis,  end-­‐stage  liver  disease  and  death.   Current  World  Health  Organization  (WHO)  ART  guidelines  recommend  the  earlier  initiation  of  ART  in   HIV-­‐HBV   co-­‐infected   individuals   with   chronic   active   hepatitis   B,   irrespective   of   CD4   count,   when   treatment  for  hepatitis  B  is  indicated.  Although  guidelines  for  managing  hepatitis  B  and  C  have  been   developed   with   high   and   middle-­‐income   countries,   there   are   currently   no   global   WHO   clinical   or   programmatic  guidelines.     In  order  to  address  this  unmet  need,  WHO  has  been  requested  by  countries  to  develop  guidance  on   viral  hepatitis  prevention  among  PWID  in  low-­‐income  and  middle-­‐income  countries.5       The  WHO  guidance  will  be  designed  to  meet  the  needs  of  government,  policy  makers,  donors,  non-­‐ governmental  organizations,  programme  managers,  health  care  providers,  patient  support  groups   and  advocates  supporting  viral  hepatitis  prevention.  A  systematic  review  of  the  evidence  has  already   been  undertaken  to  inform  recommendations  and  as  a  basis  for  this  guidance.     The  individual  needs  and  challenges  of  the  people  whose  lives  will  be  affected  by  this  guidance  are   best   understood   by   those   who   are   meeting   those   challenges.   Through   this   paper,   their   inputs   provide  a  personal  dimension  to  the  work  of  the  experts  participating  in  the  technical  review  for  the   preparation  of  this  guidance.           From   December   2011-­‐February   2012,   a   qualitative   survey   was   conducted   to   collect   the   personal   experiences   and   perspectives   of   members   of   civil   society   and   service   providers   working   on   viral   hepatitis   in   sub-­‐Saharan   Africa,   Asia,   Europe,   Latin   America   and   North   America.   Although   the   guidance  will  focus  specifically  on  viral  hepatitis  prevention  among  PWID,  respondents  were  asked  a   1  WHO.  Hepatitis  B  Fact  Sheet  N o .  204.  Geneva,  WHO,  2008.   http://www.who.int/mediacentre/factsheets/fs204/en/index.html   2  WHO.  Hepatitis  C  Fact  Sheet  N o .  164.  Geneva,  WHO,  2011.   http://www.who.int/mediacentre/factsheets/fs164/en/index.html     3  Soriano  V  et  al.  Viral  Hepatitis  and  HIV  co-­‐infection.  Antiviral  Research,  Jan;  85  (1):  303-­‐15,  2010.   4  Nelson  et  al.  Global  epidemiology  of  hepatitis  B  and  hepatitis  C  in  people  who  inject  drugs:  results  of  systematic  reviews.   The  Lancet,  Volume  378,  Issue  9791,  13  August  2011.   5  Sixty-­‐third  World  Health  Assembly,  Resolution  63.18.    Viral  Hepatitis.  WHO,  Geneva,  21  May  2010.  
  4. 4. 4 broader  range  of  questions  e.g.  on  testing  and  treatment.  The  results  from  those  questions  are  also   presented  in  this  report.    This  report  documents  the  main  issues  discussed  with  respondents,  and  it   will  contribute  to  the  systematic  review  to  inform  recommendations  and  to  prepare  guidance  on   viral  hepatitis  prevention  among  PWID.     Methods     A  qualitative  study  was  conducted  to  ensure  that  the  experiences  of  people  living  with  viral  hepatitis   or  who  are  service  providers  are  considered  along  with  the  technical  review  of  evidence  that  will   form  the  basis  of  the  guidance  on  prevention  of  viral  hepatitis  among  PWID.     An  independent  consultant  was  hired  to  conduct  a  survey  to  ensure  neutrality  in  the  discussions   with  respondents  and  analysis  of  findings.  Seventeen  people  were  identified  through  international   organizations  and  NGO  networks  and  asked  to  participate  in  anonymous,  semi-­‐structured  interviews   regarding   their   personal   experiences   and   views   on   hepatitis   testing,   HBV   vaccination,   prevention   programs   for   PWID,   hepatitis   treatment   and   co-­‐infection   with   HIV.     Fourteen   interviews   were   conducted  individually  by  phone  or  Skype.  One  interview  was  conducted  in  person  by  the  consultant,   and  two  respondents  provided  written  inputs.  All  participants  have  been  tested  for  hepatitis  and   currently  are  involved  in  programmes  addressing  issues  around  hepatitis  prevention  and  treatment   access.       A  semi-­‐structured  interview  guide  was  developed  to  guide  and  ensure  uniformity  of  interviews,  to   identify  emerging  themes  and  to  facilitate  analysis  of  findings  (See   Annex   1).  All  interviews  were   approximately  one  hour  in  length  and  most  questions  were  open-­‐ended  to  allow  for  free  discussion   of   individual   experiences,   motivations,   perspectives   and   concerns.   Interviews   were   not   recorded,   but   extensive   notes   were   taken   in   order   to   ensure   that   respondents’   inputs   were   accurately   reflected  in  the  report.  Verbal  consent  to  be  interviewed  was  obtained  from  all  participants,  and   participants  were  free  to  seek  clarification  and  to  decline  to  answer  any  questions  or  to  discuss  any   topics.         For   the   question   on   the   rapid   regimen   for   the   HBV   vaccine   regimen,   the   consultant   initially   incorrectly   described   the   rapid   regimen   to   interview   participants.   After  realizing   her   mistake,   the   consultant  emailed  the  fourteen  participants  that  she  discussed  this  question  informing  them  of  her   mistake   and,   based   on   correct   information,   re-­‐asked   the   question.   Twelve   of   the   fourteen   participants  responded  to  her.  These  responses  are  presented  in  the  results  section  of  this  report.     The  consultant’s  qualitative  analysis  of  the  discussions  shapes  the  narrative  sections  of  this  report.   These  are  intended  for  consideration  in  the  formulation  of  recommendations  on  prevention  of  viral   hepatitis  among  PWID.     Topics  of  the  interviews  included:   • Hepatitis  testing   • HBV  vaccination     • Prevention  for  PWID     • Hepatitis  treatment     • Co-­‐infection  with  HIV       Demographics    
  5. 5. 5 Table  1.  Respondent  profile  by  gender  and  nationality     Africa   Asia   Middle  East   L.  America   Russia  /  CIS   Australia   Europe   N.  America   Women   -­‐   -­‐   -­‐   3   2   Men   1   5   2   1   3         Table  2.  Respondent  profile  by  gender  and  age     30-­‐39   40-­‐49   50-­‐59   Women   3   -­‐   2   Men   2   6   4       Thirteen  of  the  17  of  key  respondents  are  living  with  HCV.  Eight  of  the  13  people  with  HCV  are  also   infected  with  HIV  (n=6),  HBV  or  HDV.  One  of  the  respondents  is  not  (and  has  never  been)  infected   with  viral  hepatitis  or  HIV.       Table  3.  Respondent  profile  by  gender  and  viral  hepatitis  and  HIV  status.  One  of  the  women  respondents  did  not  report   infection  with  viral  hepatitis  or  HIV.     HBV   HBV   HCV   HCV   HCV   HIV   HBV   HCV   HDV   HBV   HCV   HDV   HIV   Women   -­‐-­‐   1   1   1   1   -­‐   Men   3   -­‐   4   4   -­‐   1       Hepatitis  testing       “My  doctor  says  I  have  hepatitis,  but  I  shouldn’t  worry  about  it.”     Participants   had   varying   experiences   with   testing.   The   most   common   theme   expressed   by   participants  was  a  lack  of  knowledge  by  both  the  testing  providers  and  participants  themselves.  This   lack   of   knowledge   was   expressed   as   misinformation   delivered   by   providers   to   participants   in   addition   to   participants’   own   lack   of   knowledge   about   Viral   Hepatitis.   The   timing   of   testing   also   contributed  to  the  amount  of  available  knowledge.  For  participants  tested  in  the  early  1980’s,  there   was  less  available  knowledge  than  for  those  tested  in  the  last  10  years.    Many  participants  expressed   relief   that   they   were   infected   with   “only”   HCV   and   not   HIV.   One   patient   whom   initially   tested   positive   for   HIV   was   not   tested   for   HCV   until   experiencing   liver   problems   years   later.   This   was   because  he  did  not  “fit  the  profile”  of  someone  who  would  have  HCV.     All   participants   were   unanimous   in   saying   that   testing   should   be   available   in   locations   most   convenient  to  the  clients.    Based  on  the  responses  from  participants  in  different  regions,  it  seems   that   this   decision   should   be   dependent   on   the   setting.   For   example,   some   participants   from   developed   countries   said   that   testing   should   absolutely   not   be   offered   at   needle   and   syringe   programs  (NSP)  since  PWID  did  not  want  to  spend  more  time  than  necessary  at  these  sites.  On  the   other  hand,  participants  from  Asia  recommended  NSP  as  a  setting  to  offer  testing.  Methadone  and   opioid  substitution  therapy  (OST)  programs  were  recommended  provided  that  testing  not  be  used  as   an  incentive  to  access  services.  Other  participants  addressed  that  testing  needs  to  be  made  available   for  persons  who  did  not  inject  drugs  also  e.g.  hospital  hepatitis  units.  The  overall  feeling  was  that  
  6. 6. 6 viral  hepatitis  testing  should  be  linked  to  other  services,  inclusive  of  HIV  services,  and  should  include   counseling  as  part  of  the  testing  package.     Overall,   participants   stated   that   persons   who   should   be   prioritized   for   HCV   screening   are   PWID,   prisoners   and   persons   from   countries   where   HCV   (e.g.   Egypt)   and   HBV   (e.g.   China)   are   endemic.     Prevention  of  onward  transmission  was  the  most  common  cited  benefit  of  knowing  one  has  HCV   and/or   HBV.   Treatment   of   the   disease   was   the   second   most   common   benefit   of   knowing   one’s   hepatitis  status.     HBV  Vaccination     The  majority  of  participants  have  been  vaccinated  for  HBV.  Reasons  cited  for  not  being  vaccinated   were   they   have   already   been   infected   with   HBV   (and   now   have   natural   immunity),   it   was   never   offered   to   them   and   because   they   did   not   want   to   bother   with   something   else.     Although   most   participants  were  vaccinated,  they  still  reported  barriers  to  being  vaccinated  in  the  first  place.  The   most   common   was   the   number   of   injections.   Participants   found   that   needing   to   return   to   the   doctor’s   office   three   times   to   complete   the   full   course   was   inconvenient.   It   was   also   difficult   for   some  participants  to  remember  to  return  for  those  visits.    All  participants  agreed  that  PWID  should   be  prioritized  to  receive  the  HBV  vaccination.    It  was  also  recommended  that  prisoners,  migrants  and   other  people  originally  from  HBV  or  HCV  endemic  countries  should  also  be  prioritized  for  the  HBV   vaccine.         Prevention  programs  for  PWID6     “It  is  important  that  programs  address  the  importance  of  ALL  paraphernalia  being  clean  for  HCV   prevention.  “     In   general,   most   participants   said   that   the   basic   harm   reduction   package,   as   recommended   by   WHO7 ,  is  available  in  their  country.  (The  exception  to  this  is  that  participants  in  Russia  do  not  have   access   to   OST.)   The   quality   and   size   of   the   specific   harm   reduction   programs   varies   by   country.     There  is  very  limited  HCV  focused  prevention  happening  in  any  of  the  participants’  countries.  Most   of   the   reported   HCV   prevention   seems   to   piggyback   on   existing   HIV   prevention   programs.       All   participants   were   asked   if   they   would   recommend   that   their   countries   implement   additional   hepatitis   prevention   programs   other   than   the   existing   programs.   Participants   from   Russia   recommended  OST;  and  one  participant  from  the  global  North  recommended  syringe  vending  and   disposal  machines.     “Programs  that  are  well-­‐received  generally  include  current  and  former  PWID.  Providers  do  not   know  anything  about  HBV  or  HCV;  and  there  is  an  enormous  amount  of  stigma.”     All  persons  interviewed  for  this  survey  have  been  both  recipients  and/or  providers  of  preventions   services  for  PWID.    These  services  include  NSP  as  well  as  HIV  and  HCV  awareness  campaigns.  The   overarching  belief  is  that  all  services  must  be  friendly  to  drug  users.  This  means  that  the  persons   providing  the  services  should  not  stigmatize  or  infantilize  the  PWID  accessing  the  services.  Primarily   participants  from  more  developed  countries  stated  that  they  believe  current  and  former  drug  users   6  When  describing  which  prevention  programs  are  available  for  HCV  prevention  in  their  country,  none  of  the  participants   cited  the  WHO/UNAIDS/UNODC  harm  reduction  package.  They  described  components  included  in  the  harm  reduction   package.  In  fact,  only  50%  (9/17)  of  those  interviewed  stated  that  they  have  heard  of  the  WHO/UNODC/UNAIDS   recommended  HIV  prevention  interventions  for  PWID.     7  WHO,  UNODC,  UNAIDS.  Technical  Guide  for  countries  to  set  targets  for  universal  access  to  HIV  prevention,  treatment  and   care  for  injecting  drug  users.  Geneva,  WHO,  2009.  http://www.who.int/hiv/pub/idu/targetsetting/en/index.html    
  7. 7. 7 are  best  suited  to  deliver  services  to  PWID  because  they  often  feel  stigmatized  and/or  judged  by   health  care  workers.         HBV  vaccination  for  PWID  -­‐  Setting     Regarding  the  setting  for  vaccination,  participants  expressed  various  opinions  from  location  to  mode   of  service  delivery.  In  general,  it  is  felt  that  vaccination  should  be  available  at  the  same  locations  as   testing.  One  participant  suggested  that  vaccination  also  be  available  at  STI  clinics  and  in  correctional   facilities.   Many   participants   agreed   that   vaccination   should   be   linked   to   other   services   that   the   priority  groups  can  easily  access.    In  most  countries,  children  are  now  being  vaccinated  for  HBV  at   birth.   Participants   from   countries   who   do   not   implement   this   practice   questioned   why   their   countries   do   not   do   this   especially   given   the   low   price   of   the   HBV   vaccine.   They   suggested   that   vaccine  implementation  needs  to  come  from  the  national  level.       HBV  vaccination  for  PWID  -­‐  Standard  vs.  rapid  regimen     Most  of  the  participants  did  not  know  that  there  is  a  rapid  regimen  for  HBV  vaccination.    Given  the   choice,  participants  prefer  a  shorter  regimen  that  is  not  spread  out  over  six  months.  All  participants,   who  responded  to  this  question,  stated  that  the  length  over  which  the  vaccine  is  administered  is  a   barrier  to  completing  the  vaccine  regimen.     HBV  vaccination  for  PWID:    Use  of  incentives  -­‐  money  or  voucher     Although   a   few   participants   strongly   disagreed   with   the   use   of   incentives   to   encourage   HBV   vaccination,  the  majority  of  participants  were  in  favor.  However,  the  majority  stated  it  is  preferable   that  people  choose  to  be  vaccinated  because  they  want  to  take  care  of  their  health.       Provision  of  low  dead  space  syringes       Participants’   did   not   express   strong   feelings   for   or   against   low   dead   space   syringes   (LDSS).   Participants  were  most  interested  to  know  if  LDSS  syringes  could  come  in  different  sizes  and  with   removable   needles.   According   to   participants,   one   type   of   syringe   will   not   fit   all   needs.   Different   drugs   require   different   sized   syringes   and   not   all   PWID   prefer   the   same   type   of   syringe.     When   sharing  drugs,  it  is  important  for  many  to  be  able  to  remove  the  syringe  from  needle.     Psychosocial  interventions       It  was  generally  felt  by  most  participants  that  there  is  too  much  misinformation  about  viral  hepatitis   among  both  health  care  workers  and  PWID.    Respondents  were  generally  in  favor  of  psychosocial   interventions,  if  they  were  done  well.  PWID  need  more  information  on  prevention,  re-­‐infection  and   treatment.   Participants   feel   it   is   extremely   important   that   accurate   information   is   shared   appropriately.       Other  participants  were  less  optimistic.  As  one  participant  said,  “PWID  don’t  need  to  be  ”told”  about   behavior  change.  When  they  have  a  clean  needle,  they  use  a  new  needle.”    In  fact,  most  PWID  want   to  have  a  new  needle  and  use  their  own  needle.  They  prefer  not  to  share.  It  is  not  like  a  chillum   where  sharing  implies  something  brotherly.”     Many   respondents   stated   that   psychosocial   interventions   should   not   be   provided   at   needle   and   syringe  programs.  The  general  feeling  is  that  when  respondents  attend  NSPs,  the  goal  is  to  get  new   needles  and  leave,  not  linger  and  receive  additional  services.    Participants  did  not  specify  a  setting   that   would   be   better   suited   for   receiving   psychosocial   interventions.   As   expressed   for   other  
  8. 8. 8 interventions,   psychosocial   interventions   also   need   to   be   done   in   a   non-­‐discriminatory   way   by   people  with  whom  PWID  are  comfortable.     Peer  based  interventions       As   stated   by   one   participant,   “Peers   are   defined   as   a   person   who   has   a   connection   with   the   community   and   are   accepted   by   drug   users.”     The   overwhelming   majority   of   participants   stated   strongly   that   peer-­‐based   interventions   are   key   in   providing   services,   especially   to   PWID.   Respondents   said   that   having   other   peers   deliver   services   improves   the   atmosphere   of   service   delivery   because   peers,   generally,   do   not   discriminate   towards   other   peers,   which   contributes   greatly  to  their  acceptance  by  and  success  with  PWID.       7.  Treatment  of  Viral  Hepatitis         Over  half  of  those  with  HCV  have  been  treated  for  their  HCV.  Those  who  originally  had  genotypes  3   and  4  all  successfully  cleared  their  HCV  with  treatment.  Among  those  who  had  genotype  1,  only  half   successfully   cleared   their   HCV   with   treatment.     Reported   side   effects   for   those   who   underwent   treatment  seemed  to  vary  in  severity  by  genotype.  Those  with  genotype  1  reported  more  adverse   side  effects  than  those  with  genotype  3.       All   participants   reported   that   HCV   treatment   is   available   in   their   countries.   However,   cost   and   accessibility   are   barriers.   Even   in   countries   where   HCV   treatment   is   provided   for   free   by   the   government,  not  all  people  do  or  are  willing  to  access  treatment.  Anecdotal  stories  from  participants   state   that   many   PWID   do   not   want   to   enter   the   health   system   due   to   stigma   felt   by   providers,   uneven  quality  of  services  and/or  fear  that  they  will  be  reported  to  the  police.  In  some  countries,   even  though  the  treatment  is  available,  it  is  extremely  difficult  to  see  a  doctor  who  specializes  in   HCV  and  can  prescribe  the  treatment.  Many  doctors  are  apprehensive  to  prescribe  HCV  treatment   due   to   all   the   side   effects   associated   with   interferon,   which   can   complicate   the   physicians’   management  of  the  patient.    Two  participants  stated  they  are  waiting  for  the  new  (and  supposedly   better)   HCV   treatment   to   become   available   before   initiating   treatment.   In   countries   where   HCV   treatment  is  not  provided  by  the  government,  the  cost  is  prohibitively  expensive     Should  WHO  develop  HCV  treatment  guidelines?     All  participants  strongly  agree  that  WHO  should  develop  HCV  treatment  guidelines.  Participants  say   this  would  be  “…a  powerful  policy  tool  and  blueprint  for  countries  to  use.”    In  addition,  due  to  fears   that  the  price  of  new  drugs  will  be  out  of  reach  for  those  in  low  and  middle  income  countries,  it  is   regarded  as  much  more  important  that  WHO  has  an  official  stance  on  HCV  treatment.         Co-­‐infection  with  HIV  and  HBV/HCV       “Disease  progression  is  accelerated  for  both  diseases  when  co-­‐infected.”   “Better  to  do  complete  HCV  treatment  before  initiating  ART.”   “Priority  for  ART  should  be  given  to  co-­‐infected  people.”       At   the   advice   of   their   physicians,   two   of   the   participants,   both   from   Asia,   delayed   initiating   HIV   treatment  until  after  completing  their  HCV  treatment.  The  same  two  participants  were  also  advised   that  it  would  be  best  to  treat  their  HCV  when  their  HIV  viral  load  was  above  300.      
  9. 9. 9 Of  the  participants  interviewed,  six  are  co-­‐infected  with  HIV  and  HCV.  Although  he  never  failed  any   of   his   regimens,   one   participant   changed   his   ART   regimen   six   times   since   he   began   ART   due   to   complications   with   his   liver.   Another   participant   had   to   change   one   of   his   antiretroviral   (ARV)   medications  once  due  to  side  effects  and  a  third  participant  has  been  on  the  same  ART  regimen   since  2008.     Approximately  half  of  all  interviewed  had  relatively  low  general  knowledge  on  (treatment)  affecting   people  co-­‐infected  with  HIV  and  HCV/HBV.  Those  with  low  knowledge  readily  admitted  that  they   need  more  information  on  the  issues  affecting  people  co-­‐infected  with  HIV  and  viral  hepatitis.     Should  all  people  with  viral  hepatitis  initiate  ART  treatment  irrespective  of  their  HIV  CD4  count?     WHO  is  currently  reviewing  the  evidence  regarding  whether  all  people  with  viral  hepatitis  should   initiate  HIV  treatment  irrespective  of  CD4  count  Not  all  of  the  participants  have  enough  knowledge   to  answer  this  questions  authoritatively.         Those  participants  with  more  knowledge  feel  that,  in  general,  people  co-­‐infected  with  (chronic)  HBV   and  HIV  should  start  initiate  ARTs  irrespective  of  their  CD-­‐4  count  provided  they  are  on  a  therapy   that  includes  TDF  +  3TC/FTC.    One  participant  pointed  out  that  it  is  critical  to  test  people  for  HBV   before  initiating  ART  because  this  should  affect  the  ART  regimen  chosen.         For   HCV,   it   was   agreed   that   there   is   not   the   same   amount   of   evidence.   For   example,   some   participants  mentioned  that  it  is  not  preferable  to  use  nevirapine  or  zidovudine  as  treatment  for   people  co-­‐infected  with  HCV  since  these  drugs  can  damage  the  mitochondria  and/or  interact  with   ribavirin  for  people  on  HCV  treatment.  However,  two  of  the  respondents  stated  that  they  are  on  ART   regimens  that  include  these  two  ARV  medications.       Conclusion     Seventeen  individuals  shared  very  personal  stories  for  the  purposes  of  these  interviews.  To  varying   degrees,  they  stated  they  are  hopeful  that  WHO  is  looking  at  the  prevention  of  viral  hepatitis  among   PWID.      
  10. 10.     Annex  1.  Example  of  the  semi-­‐structured  interview  guide     Viral Hepatitis: Semi-structured interview M / F Provider / community member / both Age Region 1. Qualitative interview introduction Length: 45-60 minutes Primary goal: To see things the way you see them… more like a conversation with a focus on your experience, your opinions and what you think or feel about the topics covered 2. Verbal consent Would you like to participate in this interview? Verbal Consent was obtained from the study participant Verbal Consent was NOT obtained from the study participant 3. Background Information Overview: Invite interviewee to briefly tell me about him/herself: General information about background… mostly about experiences and perspectives on issues surrounding HCV, HBV and co-infection with HIV. If the interviewee openly identifies as having been tested for viral hepatitis or has viral hepatitis, probe with the next questions. Been through testing - serostatus not disclosed Been through testing - serostatus positive Been through testing - serostatus negative 4. Hepatitis testing experience Can you tell me about your HBV / HCV testing experience? • Where tested • Was your experience with testing positive or negative? o Why? • If you have not been tested, than why not? o What conditions/support would need to be in place to make you more inclined to test?
  11. 11. 11 Where should HBV/HCV testing be available? • Linked to other services? o Which ones: Vaccination? Treatment? Other? In your opinion, who should be prioritized for HBV and HCV screening? Any particular groups? What do you see as the benefit of knowing you have HBV? HCV? • Change in behavior: Alcohol use? Sharing syringes? Other? • Assess if people know that HCV/HBV diagnosis may impact HIV treatment regimen • Better information at country level re: how many people have viral hepatitis (VH) (improve surveillance) 5. HBV Vaccination Availability of HBV vaccine • Have you been vaccinated? o Why were you vaccinated? § Can you tell me about your experience? Positive or negative? Why? o Where were you vaccinated o Do you think people should get vaccinated? § If so, who in particular? • If you have not been vaccinated, than why not? o What conditions/support would need to be in place to make you more inclined to be vaccinated? • Barriers to vaccination? o Stigma? Health care workers attitude? o What could improve setting for vaccination? Setting Where should vaccination take place? • Linked to other services? Which ones: Testing? Treatment? Other? Who should be prioritized for HBV vaccination? What are your opinions/feelings about the HBV vaccine regimen? • Length of time: the different regimens – standard vs. accelerated • Ability to adhere to regimen Opinion on use of incentives? • What type? o Probe for money and voucher
  12. 12. 12 In your opinion, who should be prioritized for HBV vaccination? Any particular groups? 6. Prevention – for PWID What kinds of viral hepatitis prevention programs for PWID exist in your country? Would you recommend other prevention programs? • If yes, which ones? What is your experience with prevention programs? - Recipient? Provider? - Which ones? - Opinion? Are you aware of the 9 prevention interventions that have been recommended by the UN (WHO/UNODC/UNAIDS) for HIV prevention? 1. Needle and syringe programmes (safe use and safe injecting) noting higher intensity coverage and paraphernalia needed and type of syringes 2. Opioid substitution therapy 3. HIV testing and counselling 4. HIV care and antiretroviral therapy for IDU 5. Prevention and treatment of STI 6. Condom programme 7. Outreach; information, education and communication for IDUs and their sexual partners 8. Hepatitis diagnosis, treatment and vaccination 9. Tuberculosis prevention, diagnosis and treatment WHO is looking at additional prevention interventions in addition to the above 9. Examples include (see below) 1. Types of syringes 2. Psychosocial interventions provided by health services or peer driven to reduce injecting risk behaviour for HBV and HCV transmission. 3. HBV vaccination for PWID Probe if they have heard of these interventions? Their opinion / view? Probe 1. There is insufficient evidence to recommend providing LDSS rather than HDSS in needle distribution programs at this stage. o How do you react to this? o Is this acceptable? o What should be the message? 2. There is no evidence that psychosocial interventions reduce HCV/HBV transmission. o How do you react to this? o Is this acceptable? o What should be the message? 3. HBV vaccination recommendations
  13. 13. 13 a. Short course schedule to maximize adherence combined with higher dose of vaccine for each injection to maximize immune response b. Immediate on site availability of HBV vaccine at programs providing HBV vaccine or working closely with PWID populations. c. Where appropriate and available, modest monetary incentives can be used to increase completion and received second short rates o How do you react to this? o Is this acceptable? o What should be the message? 7. Treatment of Viral Hepatitis Explore thoughts about viral hepatitis treatment Explain that these guidelines will not address treatment of VH alone. Can mention TDF based ART will treat HBV. . For each topic, differentiate between HBV and HCV treatment. • If you have viral hepatitis, have you been treated? o Why/ why not? o What was your experience with it? § Side effects, adherence, other problems? • Is treatment widely available in your country? o Where? o Quality of services? o Accessibility, cost? o Acceptability of service delivery? Do you think WHO should develop HCV treatment guidelines…? 8. Co-infection with HIV and HBV/HCV – for all co-infected, not only PWID Explain that this guidance in development will focus on the treatment of HIV in patients co-infected with HBV/HCV. For ART treatment initiation and regimen, it is important to assess co-infection. -- Focus on questions that relate to this --- Are you co-infected with HIV and HBV/HCV? • Are you on ART? • If yes: has having viral hepatitis affected your ART regimen o If yes, how/why? • Any additional side effects to ART regimen because of (or thought to be because of) co-infection? Explore • Knowledge of issues • Knowledge of Treatment issues: has this affected your regimen?
  14. 14. 14 WHO is currently reviewing the evidence regarding whether all people with VH should initiate HIV treatment irrespective of CD4 count. • HBV? • HCV? • Opinion on this? • Is this realistic in your setting? o Availability, access? • What about in the context of low and middle-income countries? o Effect on the clinical and eligibility criteria?
  15. 15.     Annex  2.  Results  of  Values  and  Preferences  survey  as  related  to    the  PICO  questions  from   the  guidelines   Question  1:    Should  a  rapid  HBV  vaccination  regimen  versus  a  standard  HBV  vaccination  regimen   be  used  among  PWID?     The  values  and  preferences  study  found  the  most  common  reported  barrier  to  HBV  vaccination  to   be  the  length  of  time  between  injections.  Approximately  half  of  all  participants  found  returning   three  times  over  the  course  of  6  months  to  be  a  barrier  fro  vaccine  completion.  Most  participants   were  not  aware  of  the  rapid  regimen  for  HBV  vaccination.    Given  the  choice,  participants  prefer  to   have  the  regimen  delivered  over  a  shorter  length  of  time.         Question  2:  Should  incentives  for  HBV  vaccination  completion  versus  no  incentives  be  used  among   PWID?     The  values  and  preference  survey  found  the  majority  of  respondents  in  favour  of  incentives  for   increasing  vaccination  rates,  although  some  were  strongly  against.  Vouchers  (for  food  or  transport)   were  raised  as  an  alternative  to  money  as  an  incentive.  The  majority  stated  it  was  preferable  that   people  choose  to  be  vaccinated  because  they  want  to  take  care  of  their  health.       Question  3:    Should  low  dead  space-­‐syringes  versus  high  dead  space  syringes  be  provided  to  PWID?     Participants’  did  not  express  strong  feelings  for  or  against  LDSS.  Participants  were  most  interested  to   know  if  LDSS  syringes  could  come  in  different  sizes  and  with  removable  needles.  According  to   participants,  one  type  of  syringe  will  not  fit  all  needs.  Different  drugs  require  different  sized  syringes   and  not  all  PWID  prefer  the  same  type  of  syringe.    When  sharing  drugs,  it  can  be  important  to  be   able  to  remove  the  syringe  from  the  needle       Question  4:    Should  psychosocial  interventions  versus  no  psychosocial  interventions  be  used   among  PWID?     The   values   and   preferences   survey   found.   Respondents   were   generally   in   favor   of   psychosocial   interventions,  if  they  were  done  well.  PWID  need  more  information  on  prevention,  re-­‐infection  and   treatment.   Participants   feel   it   is   extremely   important   that   accurate   information   is   shared   appropriately.   Participants   did   not   specify   a   setting   that   would   be   better   suited   for   receiving   psychosocial  interventions.       Question  5:  Should  peer  based  interventions  versus  no  peer  based  interventions  be  used  among   PWID?     The  overwhelming  majority  of  participants  stated  strongly  that  peer-­‐based  interventions  are  key  in   providing  services,  especially  to  PWID.  As  stated  by  one  participant,  “Peers  are  defined  as  a  person   who  has  a  connection  with  the  community  and  are  accepted  by  drug  users.”    Respondents  said  that   having   other   peers   deliver   services   improves   the   atmosphere   of   service   delivery   because   peers,   generally,  do  not  discriminate  towards  other  peers,  which  contributes  greatly  to  their  acceptance  by   and  success  with  PWID.  
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