ARV s and Treatment Guidelines

Transcription

1 ARV s and Treatment Guidelines Garry Brough Terrence Higgins Trust UK CAB Steering Group member Community Rep on BHIVA ExecuDve CommiFee Community Rep on HIV CRG

2 Treatment InformaDon/Resources ibase: Treatment Training Manual, PDFs, powerpoints, online courses (eg drug resistance) NAM: HIV Basics, HIV Treatment Factsheets and booklets, e- bulledns myhiv/tht: General info, personal experiences on video and in Community Forums, text message reminders hfp:// druginteracdons.org site or app

3 hfp://i- base.info/english- treatment- training- manual/

4 hfp:// basics/treatment/page/ /

5 hfp:// treatment/cat/1378/

6 hfp:// and- you/your- treatment

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8 Add pic for hiv- druginteracdon

9 BHIVA guidelines are developed using an explicit methodology based on five core principles: 1. Development is carried out by nadonally representadve experts in the field of HIV medicine who are free of overt conflicts of interest. 2. The expert group commissions a systemadc review to idendfy and cridcally appraise the evidence. 3. RecommendaDons using the GRADE system are explicitly linked to the suppordng evidence. 4. RecommendaDons take account of equality issues, financial and resource implicadons, and padent choice and lifestyle. 5. RecommendaDons are open to public review including the full membership of BHIVA, stakeholders, padents and interested members of the public.

10 Grading recommendadons The grading system provides an informadve, transparent summary for clinicians, padents and policy makers by combining an explicit evaluadon of the strength of the recommendadon with a judgment of the quality of the evidence for each recommendadon.

11 Two- level grading strength of recommendadon A Grade 1 recommendadon is a strong recommendadon to do (or not do) something, where the benefits clearly outweigh the risks (or vice versa) for most, if not all padents. We recommend A Grade 2 recommendadon is a weaker recommendadon, where the risks and benefits are more closely balanced or are more uncertain. We suggest

12 Grading quality of evidence Grade A evidence means high- quality evidence that comes from consistent results from well- performed randomised controlled trials, or overwhelming evidence of some other sort (such as well- executed observadonal studies with very strong effects). Grade B evidence means moderate- quality evidence from randomized trials that suffer from serious flaws in conduct, inconsistency, indirectness, imprecise esdmates, repordng bias, or some combinadon of these limitadons, or from other study designs with special strength. Grade C evidence means low- quality evidence from observadonal evidence, or from controlled trials with several very serious limitadons. Grade D evidence is based only on case studies or expert opinion.

13 BriDsh HIV AssociaDon (BHIVA) recommends treatment for padents: with chronic infecdon if CD4 cell count is 350 cells (1A) presendng with primary HIV infecdon and meedng any one of the following criteria: Neurological involvement (1D). Any AIDS- defining illness (1A). Confirmed CD4 cell count <350 cells (1C). following discussion, if a padent with a CD4 cell count >350 cells/ml wishes to start ART to reduce the risk of transmission to partners, this decision is respected and ART is started. hfp://

14 BHIVA recommends padents with the following condidons start ART: AIDS diagnosis (e.g. KS) irrespecdve of CD4 cell count (1A). HIV- related co- morbidity, including HIVAN (1C), idiopathic thrombocytopenic purpura (1C), symptomadc HIV- associated NC disorders irrespecdve of CD4 cell count (1C). CoinfecDon with HBV if CD4 cell count is 500 cells/ml (1B). CoinfecDon with HCV if CD4 cell count is 500 cells/ml (1C) NADMs (non- AIDS- defining malignancies ) requiring immunosuppressive radiotherapy or chemotherapy (1C) hfp://

15 European AIDS Clinical Socity (EACS) ART is always recommended in any HIV- posidve person with a current CD4- count below 350. The consideradon to start ART should be individualized regardless of CD4- count and plasma HIV RNA level, especially if a padent is requesdng ARV therapy and ready to start, and/or for any other personal reasons. In serodifferent partners, early inidadon of ART as one aspect of the overall strategy to reduce HIV transmission to the seronegadve partner should be strongly considered and acdvely discussed. hfp://

16 EACS Co- morbidides chart R Recommend C Consider D Delay

17 US NaDonal InsDtutes of Health (NIH) AnDretroviral therapy (ART) is recommended for all HIV- infected individuals to reduce the risk of disease progression. The strength and evidence for this recommendadon vary by pre- treatment CD4 cell count: CD4 count <350 cells/mm3 (AI); CD4 count cells/mm3 (AII); CD4 count >500 cells/mm3 (BIII). ART also is recommended for HIV- infected individuals for the prevendon of transmission of HIV. The strength and evidence for this recommendadon vary by transmission risks: perinatal transmission (AI); heterosexual transmission (AI); other transmission risk groups (AIII). PaDents stardng ART should be willing and able to commit to treatment and understand the benefits and risks of therapy and the importance of adherence (AIII). PaDents may choose to postpone therapy, and providers, on a case- by- case basis, may elect to defer therapy on the basis of clinical and/or psychosocial factors. hfp://aidsinfo.nih.gov/guidelines/html/1/adult- and- adolescent- arv- guidelines/0

18 WHO Guidelines 2013: public health approach including prevendon <500 but prioridsing those <350 or with advanced disease At any CD4 count for: people with comorbidides such as TB, HepaDDs, in serodiscordant reladonships, pregnant or breasseeding women, children younger than five hfp://

19 RepresenDng the community view(s) in the UK Addressing controversies: When to start... What to start with...

20 Current BHIVA treatment guidelines Summary recommendadons for choice of ART: NRTI backbone Third agent - Preferred Tenofovir and emtricitabine Atazanavir/ritonavir Darunavir/ritonavir Efavirenz Raltegravir AlternaDve Abacavir and lamivudine* Lopinavir/ritonavir Fosamprenavir/ritonavir Nevirapine Rilpivirine *Abacavir is contraindicated if HLA- B*57:01 posidve. Nevirapine is contraindicated if baseline CD4 cell count is greater than 250/400 cells/ml in women/men. Use recommended only if baseline VL < copies/ml: rilpivirine as a third agent, abacavir and lamivudine as NRTI backbone. The presence or future risk of co- morbidi?es and poten?al adverse effects need to be considered in the choice of ARV drugs in individual pa?ents. hfp:// Page 12

21 Page 31 - caveats Neuropsychiatric side effects have commonly been reported in padents treated with EFV and padents with a history of psychiatric disorders appear to be at a greater risk of serious psychiatric adverse events [24]. In padents with a current or a history of psychiatric disorders, including depression, anxiety and suicidal ideadon, caudon should be exercised in prescribing EFV and strong consideradon given to using an acceptable alternadve third agent.

22 What do you think are the 3 most important factors/issues to consider in reladon to new ARV approval for UK use?

23 Some key quesdons What factor will/should cost play in prescribing guidelines? How will/should the availability of generics affect prescribing? How will pricing of new drugs affect ability of clinics to prescribe them?

24 Thank you! Contact: