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Preparing to start ART: Information and Readiness

Preparing to start ART: Information and Readiness. Common feelings about starting ART. Uncertainty; questioning your need for /the value of ART or about the impact on your life? Anxiety; about side effects, drug resistance, maintaining confidentiality etc?

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Preparing to start ART: Information and Readiness

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  1. Preparing to start ART: Information and Readiness

  2. Common feelings about starting ART • Uncertainty; questioning your need for /the value of ART or about the impact on your life? • Anxiety; about side effects, drug resistance, maintaining confidentiality etc? • Lacking confidence; wondering if you have the knowledge, understanding and ability to take medicines reliably? • And many other feelings specific to you & your own personal circumstances

  3. Potential barriers to starting treatment • Other competing priorities in daily life e.g. finances, housing, childcare, work & relationships • Concerns around the tolerability of medicines • Confidentiality/privacy concerns • Other co-existing health problems perhaps with additional medicines • Mental health worries such as depression • Concerns around ease of access to treatment, care & support

  4. What is needed in order to feel ‘ready’ to start • Information & Knowledge • Communication & Involvement • Access to care and support

  5. Part AInformation; feeling well informed By the end of this section you should: • Have a good understanding of the basic life cycle of HIV • Understand and appreciate the relevance of CD4 counts and viral load measurements • Understand the basics of how antiretroviral therapy (ART) works • Know why a combination of these medicines, taken reliably/as prescribed, is necessary to achieve good results

  6. Be well informed! • Have a basic understanding of how drug resistance develops • Feel more confident in your understanding of ART • Feel more confident in decision making in relation to whether or not to start taking ART, and if not yet ready, to consider possible strategies needed for you to reach that point

  7. The lifecycle of HIV • Almost all organisms, including most viruses, store their genetic material on long strands of Deoxyribonucleic Acid (DNA) • Retroviruses are different because their genes are composed of Ribonucleic Acid (RNA) • HIV belongs to this class of viruses • HIV can only make new copies of itself inside human cells • Viral proteins attach to the surface of the cell to gain entry

  8. HIV - life cycle HIV CD4 Cell Viral proteins attach to the cell’s surface to gain entry into the cell[1] [1] Adapted from AIDSinfo. The HIV Life Cycle. http://www.aidsinfo.nih.gov/contentfiles/HIVLifeCycle_FS_en.pdf. Accessed Jan 2014

  9. HIV - life cycle CD4 Cell An HIV enzyme called reverse transcriptase converts the single-stranded HIV RNA to double-stranded HIV DNA[1] [1] Adapted from AIDSinfo. The HIV Life Cycle. http://www.aidsinfo.nih.gov/contentfiles/HIVLifeCycle_FS_en.pdf. Accessed Jan 2014

  10. HIV - life cycle CD4 Cell Viral DNA enters the host cell’s nucleus and a viral enzyme called integrase integrates into the host cell’s DNA[1] [1] Adapted from AIDSinfo. The HIV Life Cycle. http://www.aidsinfo.nih.gov/contentfiles/HIVLifeCycle_FS_en.pdf. Accessed Jan 2014

  11. HIV - life cycle CD4 Cell An HIV enzyme called the Protease cuts the long chains of HIV proteins into smaller proteins. A new virus particle is assembled[1] [1] Adapted from AIDSinfo. The HIV Life Cycle. http://www.aidsinfo.nih.gov/contentfiles/HIVLifeCycle_FS_en.pdf. Accessed Jan 2014

  12. HIV - life cycle CD4 Cell The newly assembled virus pushes out from the host cell and steals part of the cell’s outer envelope[1] The new copies of HIV can now move on to infect other cells[1] [1] Adapted from AIDSinfo. The HIV Life Cycle. http://www.aidsinfo.nih.gov/contentfiles/HIVLifeCycle_FS_en.pdf. Accessed Jan 2014

  13. What is a CD4 count? • A T-cell is a special kind of white blood cell. The more you have, the stronger your immune system[1] • CD4 cells are a type of T-cell that help co-ordinate all the different types of immune cell • The number of CD4 cells (a type of T-cell) you have is also known as your CD4 count. This is determined by a specific blood test[1] • HIV enters into some of these blood cells. When these HIV-infected blood cells make more copies of themselves, they make more copies of HIV as well[1] • HIV can also destroy these cells [1] AIDS InfoNet. Fact Sheet Number 124. CD4 Cell Tests. Revised March 2013. http://www.aidsinfonet.org/uploaded/factsheets/13_eng_124.pdf . Accessed October 2013 [2] AVERT. Starting antiretroviral treatment. http://www.avert.org/antiretroviral.htm . Accessed October 2013

  14. Your CD4 count • After living with HIV for a while (if you don't take ART) your CD4 count will usually decrease.[1,2] This is a sign that your immune system is being weakened • The lower your CD4 count, the more you risk becoming unwell[3] • A normal CD4 count for someone without HIV is usually between 500 and 1,200 cells/mm3 [1] • The CD4 percentage is also an important consideration in deciding when to start ART [1] AVERT. Starting antiretroviral treatment. http://www.avert.org/antiretroviral.htm . Accessed October 2013 [2] AVERT. Continuing Antiretroviral (ARV) Treatment. http://www.avert.org/arv-treatment.htm. October 2013 [3] AIDS InfoNet. Fact Sheet Number 124. CD4 Cell Tests. Reviewed March 2013 http://www.aidsinfonet.org/uploaded/factsheets/13_eng_124.pdf . Accessed October 2013

  15. CD4 count – what it means for your health • While your CD4 count is higher your immune system still gives you protection from disease[1] • Below 350 cells/mm3 - you may be at a higher risk of infections • With CD4 counts falling below 200 cells/mm3 – you risk developing opportunistic infections such as an HIV specific pneumonia (PCP)[1,2] [1] HIV i-base. Introduction to combination therapy. Edition April 2013 http://i-base.info/guides/files/2010/07/Starting-July-2010.pdf. Accessed October 2013 [2] AIDS InfoNet. Fact Sheet Number 124. CD4 Cell Tests. Revised March 2013. http://www.aidsinfonet.org/uploaded/factsheets/13_eng_124.pdf . Accessed October 2013

  16. What is viral load? • The term ‘viral load’ describes the amount of HIV in your blood • It is important to look at trends in your blood results over time rather than making decisions based on a single test result • If you are not on treatment, the higher your viral load: • the faster your CD4 cell count will fall[1] • The more likely you are to transmit HIV • The more likely you are to have symptoms • If you are taking ART, a detectable viral load can mean that the levels of drug in your bloodstream are too low, or indicate developing drug resistance. This needs to be closely monitored[1] • An undetectable viral load does NOT mean eradication or cure, but it does mean that viral activity is being suppressed [1] http://www.aidsmap.com. NAM/aidsmap information leaflet series; ‘CD4, Viral Load and other tests’, 2nd Edition 2012. Accessed October 2013

  17. Viral load ‘on treatment’ • In places where they are available, viral load tests are carried out when HIV is diagnosed/before starting ART and shortly after treatment is started[1] • The aim of ART is to keep the viral load as low as possible; for most people this is <50 copies per millilitre of blood[1] • This very low level is sometimes referred to as ‘undetectable’, indicating that activity of the virus is suppressed[1] • Ideally this ‘undetectable level’ will be reached within 16 weeks of starting ART, but for some people it can take up to 6 months, especially if your viral load was high before treatment (more than 100,000 copies/ml)[2] [1] http://www.avert.org/starting-monitoring-switching-treatment. Accessed October 2013 [2] The Body. The Complete HIV/AIDS Resource. http://www.thebody.com/content/art1040.html. Accessed October 2013

  18. Stages of HIV disease without treatment http://aids.gov/hiv-aids-basics/just-diagnosed-with-hiv-aids/hiv-in-your-body/stages-of-hiv/

  19. Stages of HIV disease without treatment

  20. Progression of HIV without treatment

  21. The effects of untreated HIV on the body • Since 1983 it has been well known that HIV causes damage to the immune system, making the person susceptible to opportunistic infections[1] • Today it is now also recognised that, when left untreated, HIV also leads to immune activation of certain blood cells and also to chronic inflammation[1] • This chronic inflammatory process may increase risk of other disorders e.g. heart disease and stroke, bone problems and some cancers, accelerate ageing and promote progression of some co-existing infections like hepatitis B & C[1] [1] AIDS InfoNet. Facts Sheet Number 484. HIV and Inflammation. http://www.aidsinfonet.org/fact_sheets/view/484Accessed October 2015

  22. What is Antiretroviral Therapy (ART)? • Currently there are six different types (classes) of drugs that work at different stages of the HIV life cycle[1] • ART refers to a combination of such drugs (usually 3 or more different medicines) used to treat HIV[1] • HIV treatment is also sometimes called ‘combination, triple or quadruple therapy’ or ‘HAART’ (Highly Active Anti-Retroviral Therapy)[1] • These medicines are also sometimes referred to as ‘ARVs’ (Anti-Retroviral)[1] • Several recommended ART drug combinations are available combined as single tablets [1] http://i-base.info/guides/wp-content/uploads/2013/11/Intro-guide-Nov2013e.pdf accessed January 2015

  23. Classes of antiretroviral drugs • Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs); interfere with the action of an HIV protein called Reverse Transcriptase which the virus needs to make new copies of itself • Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs); also stop HIV from replicating within cells by inhibiting the reverse Transcriptase protein • Protease Inhibitors (PIs); inhibit Protease, which is another protein involved in the HIV replication process • Fusion Inhibitors; prevent HIV from binding to or entering human immune cells • Integrase Inhibitors; interfere with the Integrase enzyme which HIV needs to insert its genetic material into human cells • CCR5 Inhibitors; another type of entry inhibitor • In excess of 30 different ART drugs are now available, in a number of different & effective combinations! Source: AVERT. Approved antiretroviral drugs; http://www.avert.org/antiretroviral-drugs.htm . Accessed October 2015

  24. How does ART work? • All cells, including viruses, replicate, i.e. they make more copies of themselves. HIV drugs work by stopping the virus replicating[1] • This brings viral load down to very low levels • The immune system (CD4 count) then has a chance to become stronger again[1] • Regular monitoring, using blood tests, will check http://i-base.info/guides/wp-content/uploads/2015/09/pocket-ARTe.pdfthat the drugs continue to work[1] [1] http://i-base.info/guides/wp-content/uploads/2015/09/pocket-ARTe.pdf. Accessed Oct 2015

  25. How does ART work? (continued) • The aim of ART is then to maintain the viral load at an ‘undetectable’ level (i.e. below 50 copies/ml)[1] • Combination therapy (using at least three drugs) has now been used for over 15 years • Many of the individual drugs used have been studied for even longer • How long a combination will work depends on not developing resistance and how well it is tolerated[1] [1] http://i-base.info/guides/wp-content/uploads/2015/09/pocket-ARTe.pdf. Accessed Oct 2015

  26. Understanding drug resistance • When HIV replicates it often makes slight mistakes, so that each new generation of HIV differs slightly from the one before[1] • These tiny differences in the structure of HIV are called mutations[1] • Occasionally some of the mutations occur in the parts of HIV that are targeted by antiretroviral drugs. An accumulation of one or more mutations can lead to the development of drug resistance over time[1] • So although there is some HIV that continues to be attacked by the drugs, there are other mutated strains of HIV that escape[1] [1] AVERT. Continuing Antiretroviral (ARV) Treatment. http://www.avert.org/arv-treatment.htm. Accessed October 2013

  27. Understanding drug resistance (continued) • When someone has drug resistant HIV the viral load rises and the risk of the person becoming ill increases[1] • If resistance develops, the drug combination usually needs to be changed[1] • If resistance occurs to one drug, resistance to other similar drugs within the same class may also develop. This is called cross resistance[1] • Taking ART reliably and suppressing the ability of the virus to replicate effectively, dramatically reduces the possibility of resistance occurring[1] [1]www.avert.org ‘Starting, Monitoring and Switching HIV Treatment’, accessed April 2014

  28. Drug resistance tests • Most guidelines advise that resistance testing should be done as close to HIV diagnosis as possible, when viral load is detectable & whenever an ART regimen is to be started or changed[1,2] • A resistance test involves giving a blood sample which will be sent for specialist analysis • Resistance tests are most accurate if your viral load is at or above 1000 copies/ml (although testing may be possible with viral load as low as 200 copies)[3] • Resistance tests are more accurate if they are performed while you are still taking ART or within a few weeks of stopping it[1] • The two types of tests - genotypic and phenotypic - both have their advantages and disadvantages[1,4] [1] BHIVA guidelines; http://www.bhiva.org/documents/Guidelines/Treatment/2015/2015-treatment-guidelines.pdf. Accessed Oct 2015 [2] European AIDS Clinical Society (EACS). Guidelines. Version 7 {2013} – Accessed Jan 2014 http://www.labtestsonline.org/understanding/analytes/hiv_genotypic/sample.html. Accessed Jan 2014 [3]Expert opinion of Dr Laura Waters, accessed April 2014 [4] British HIV Association guidelines for the routine investigation and monitoring of adult HIV-1-infected individuals; HIV Medicine (2011), 13, 1–44.accessed 2013

  29. How resistance develops Key to symbols * Drug-resistant HIV Drug-sensitive HIV Increasing viral load * Treatment Begins time Adapted from NAM. Adherence & Resistance Booklet. First edition, 2009. http://www.aidsmap.com/v634365653513570000/file/1003808/Adherence_and_Resistance_pdf Accessed October 2013

  30. Preparing to start ART

  31. Considerations for successful treatment • Other current medications • Own medical and family history, including co-existing conditions • Risk of and/or planned pregnancy, contraception • Individual ‘readiness’[1] • Pill swallowing ability/ pill size and burden • Lifestyle restrictions • Social circumstances • Sexual partnerships and partner transmission prevention • Considerations for prescribers – e.g. cost, health insurance, local policy and drug availability • Baseline tests and investigations [1] Gebrekristos HT et al. BMJ 2005;331:772-775 All other points listed are the expert opinion of B. West , J. Bennett & R Fieldhouse, Treat.info CIC. 2014

  32. Starting ART - clinical preparation • Blood chemistry (includes: liver, kidney , bone health markers) • Full blood count (includes: white blood cells, haemoglobin and clotting ability) • Blood tests for Hepatitis, Cytomegalovirus, Toxoplasma and Sexual Health screens • Viral load, CD4 count and CD4% • Drug resistance and HLA B5701 test • Cardio Vascular Disease risk assessment (includes; Body Mass Index, blood fats & blood pressure) • Tropism testing may be considered Reference: European AIDS Clinical Society (EACS). Guidelines. Version 7 – October 2013

  33. When are you ready to start ART? • Many factors should be taken into account when deciding when is the right time to start ART • Your level of commitment, including motivation, incentives and personal goals, are major factors influencing treatment decisions[1] • Readiness depends on many factors, such as knowledge, your physical and mental health, previous HIV related illness, level of social support, etc.[1] [1] Gebrekristos HT et al. BMJ 2005;331:772-775

  34. Consider & discuss your beliefs & concerns • Research shows that the greater your concerns about treatment and the less confidence you have in its benefit the greater the risk of reduced adherence to treatment[1] • Discuss your concerns in depth with your Health Care Team and devise ways of coping with the predictable challenges • Set up a support network in advance of starting treatment • Identify your goals and motivations and discuss these with your HCP • Make sure you understand your clinical condition and its implications for your health so that you can make informed decisions about treatment [1] Ref; Horne R., et al; PLOS One. Understanding patients’ adherence-related beliefs about medicines prescribed for long-term conditions: a meta-analytic review of the Necessity-Concerns Framework. Viewed April 2014

  35. Preparing to start ART Before starting it is important to have: Basic knowledge of HIV transmission and prevention Basic understanding of ART & the possible side effects A belief that treatment is effective Anticipation that the benefits of ART will outweigh possible disadvantages Ability to understand, cope with, and adhere to the recommended treatments, as prescribed A supportive environment, including a good relationship with your clinic, to help you manage your treatment A willingness to address other possible obstacles to ART success Ref; Gebrekristos HT et al. BMJ 2005;331:772-775

  36. Risk of HIV transmission reduces with ART • Recent research found a significant reduction in HIV-1 transmission risk when ART is given to HIV+ partners (within heterosexual discordant couples)[1] • Most HIV transmissions occurred from those who had high viral loads[2] • Importantly a potential for transmission to sexual partners still remains, even after ART initiation[2] • There is a need for further studies in other groups such as MSM although recent data showed no MSM transmissions in sero-different couples where the positive person was undetectable on ART (for 16,400 unprotected sex acts!)[2] [1] Cohen MS et al. N Engl J Med 2011. Available at http://www.nejm.org/doi/full/10.1056/NEJMoa1105243#. Accessed Jan 2014 [2] Donnell D et al. Lancet 2010; 375:2092–2098 [3] Rodger A et al. HIV transmission risk through condom-less sex if HIV+ partner on suppressive ART: PARTNER Study. 21st CROI, 3-6 March 2014, Boston. Oral abstract 153LB

  37. CD4 count response on ART > 350 1000 201-350 < 200 CD4 at baseline 800 600 Median CD4+ Cell Count (cells/mm3) 400 200 0 0 1 2 3 4 5 6 Years on ART [1] Adapted from Moore RD et al. Clin Infect Dis 2007;44:441-446

  38. Additional benefits of starting ART • After starting ART you will probably begin to develop: • Increased knowledge that helps you cope with and manage your HIV status and treatment[1] • Increased confidence and skills in self management[1] • An ability to recognise many treatment related side effects and/or HIV related infections[1] • Increased capacityto take action that promotes your health and well being[1] • A reassurance that comes with the knowledge that there is likely to be a reduced risk of transmitting the virus to others[2,3] [1] Gebrekristos HT et al. BMJ 2005;331:772-775 [2] Castilla J et al. J Acquir Immune Defic Syndr 2005;40;96-101 [3] Cohen MS et al. N Engl J Med 2011. Available at http://www.nejm.org/doi/full/10.1056/NEJMoa1105243#. All accessed Jan 2014

  39. Side effects - what to expect • All medicines have the potential to cause unwanted effects[1] • Some side effects are to be expected, but they are not inevitable[1] • Most side effects are short term, mild and manageable[1] • Your health care team are experienced at giving clinical support and advice to help to relieve these effects[1] • Do not hesitate to seek advice on any new symptoms, especially possible (but uncommon) allergic responses including fever and rash symptoms[1] [1] Expert opinion of BEST Advisory Board and Review Committee; agreed on 24September 2009

  40. Possible ART related side effects and how to manage them • Nausea - usually short lived. If at risk then try preventative anti-sickness medication at the start of your new regimen and seek dietary advice • Diarrhoea - again usually short term and manageable. Keep a diary recording amount, consistency and frequency. Opioids are the mainstay of treatment. Seek dietary advice[1] • Central nervous system side effects - such as dizziness and sleep disturbance; tend to occur in the first 2-4 weeks of treatment. Taking treatment at night and on an empty stomach often reduces symptoms[2] • Yellowing of the skin (hyperbilirubinemia)[3]- For a few it can be unsightly but is considered clinically harmless & resolves when treatment is stopped [1] AVERT. Antiretroviral Drugs Side Effects. http://www.avert.org/antiretroviral-drugs-side-effects.htm Accessed 2015 [2] NAM. Nausea, diarrhoea and mood/sleep disorders. Available at http://www.aidsmap.com/Nausea-diarrhoea-and-moodsleep-disorders/page/1254970/. Accessed April 2014 [3] HIV i-base. Side effects and other complications. Available athttp://i-base.info/guides/side/bilirubin-and-jaundice Accessed 2013

  41. Possible side effects - continued • Most professionals agree that HIV infection itself plus family history, some ART meds and smoking contribute to varying degrees to the increased incidence[1] • There are several strategies that can reduce risk. Stopping smoking is the most significant • Evidence suggests newer treatments are much less likely to cause body fat changes[2] • Knowledge about management and treatment to improve appearance in those affected has also improved[1] [1] Expert current opinion of Treat.info writers 2015 [2] Jemsek et al. Clinical Infectious Diseases 2006;42:273-280

  42. What is ‘adherence’? • Taking medication doses exactly as they have been prescribed, e.g. the correct doses and at the correct times • Sticking to other instructions such as dietary requirements • Not taking other drugs or substances which interact with your medicines • Not Forgetting or omitting dose(s) • Completing the medication course Expert opinion of Treat.info writers 2015

  43. Simplified relationship between adherence and drug resistance Resistance Adherence and the emergenceof resistant virus strains Probability of resistant strain emerging AdherenceAntiretroviral potency 0% 100% Adapted from Friedland GH et al. AIDS 1999;13(Suppl 1):S61–72

  44. Preparing for adherence • Adherence is the most important element under your control, that contributes to the success of your treatment[1] • Try to address the potential barriers to adherence in advance of starting your ART, if at all possible • Adherence can be complicated and unpredictable, and is a very individual matter, however your health care team can do much to support you[1] [1] NAM http://www.aidsmap.com/v634365653513570000/file/1003808/Adherence_and_Resistance_pdf.pdf Accessed Jan 2014

  45. Preparing for adherence – the latest... • Adherence to HIV medicines is higher than for most other chronic diseases[1] • Dosing schedules and improved tolerability means adherence to ART is much easier today than in the past and as a result, more convenient[2] • Recent studies suggest that the longer half-lives (e.g. Efavirenz) and/or high barriers to resistance (with boosted Protease Inhibitors) may make the drugs more forgiving of lapses in adherence[3] • However, it is unclear if HIV replication is completely suppressed when adherence is less than perfect[4] • Lower drug exposure at the end of dosing intervals with some once-daily regimens may make those regimens less forgiving of suboptimal adherence[5] • The message is still… aim for perfect adherence. Get support if this proves challenging [1] DiMatteo. MedCare 2004:42: 200-209 [2] Willig J et al. AIDS 2008;22:1951-1960 [3] Expert opinion of Dr L Waters, Medical Adviser , Treat.info, accessed October 2015 [4] Pasternak AO et al. Modest nonadherence to antiretroviral therapy promotes residual HIV-1 replication in the absence of virological rebound in plasma. J Infect Dis: online edition, 2012. Accessed Jan 2014 [5] Echo /RESIST studies – summarised at http://www.natap.org/2011/HIV/PIIS0140673611609835.pdf 2015

  46. Why do people miss doses? % 0 10 20 30 40 50 60 52 Too busy / simply forgot 46 Away from home 45 45 Change in daily routine 27 Felt depressed / overwhelmed 20 Took drug holiday / medication break 20 Ran out of medication 19 Too many pills 19 Worried about becoming 'immune' 18 Felt drug was too toxic N=133 17 Wanted to avoid side effects 17 Didn't want others to notice 16 Reminder of HIV infection 14 Confused about dosage direction 13 Didn't think it was improving health 10 To make it last longer 9 Were told the medicine is no good Adapted from Gifford AL et al. J Acquir Immune DeficSyndr2000;23:386–395

  47. Tips for effective treatment adherence • Good preparation is vital • Plan ahead, especially for changes from your usual daily routine • Devise systems to remind you of your dosing times • Keep a diary of doses taken, any missed doses and any side effects • Don’t try to put up with side effects - seek advice as soon as possible Expert opinion of the treat.Info writers 2014

  48. What to expect from your treatment: A summary • You will need to commit to taking medicines regularly and attending medical follow-up appointments[1,2] • You may have side effects in the short term but the majority of these are manageable and reduce dramatically over time[1,2] • Most people feel an increase in energy levels once viral load becomes undetectable[2] • Many feel reassured and more confident when they see evidence of treatment success[2] • The risk of you passing on the virus to your sexual partners is lessened dramatically, once your viral load is undetectable[3] • Current regimens are extremely effective, if they are taken correctly[1,2] • Longer term side effects can occur but knowledge of these is expanding continuously and most can be effectively managed[2] [1] Gathe J. J Acquir Immune DeficSyndr2003;34 (Suppl 2):S118-S122 [2] Expert opinion of theTreat.info writers 2014 [3] Grulich A et al. HIV transmission in male serodiscordant couples in Australia, Thailand and Brazil. 2015 Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, USA, abstract 1019LB, 2015

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