HIV and HIV chemotherapy
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1 HIV and HIV chemotherapy Adapté des exposés de la Chaire Franqui 2003 "Antiviral drugs and Discoveries in Medicine" Prof. E. De Clercq, KU-Leuven du Dr J. achega, Johns Hopkins University donné à l'ecole de Pharmacie en
2 Adults and children estimated to be living with HIV/AIDS as of end 2002 orth America Caribbean Latin America 1.5 million Western Europe orth Africa & Middle East Sub-Saharan Africa 29.4 million Eastern Europe & Central Asia 1.2 million East Asia & Pacific South 1.2 million & South-East Asia 6 million Australia & ew Zealand million 2
3 Estimated number of adults and children newly infected with HIV during 2002 orth America Caribbean Latin America Western Europe orth Africa & Middle East Sub-Saharan Africa 3.5 million Eastern Europe & Central Asia East Asia & Pacific South & South-East Asia Australia & ew Zealand million 3
4 Estimated adults and child deaths due to HIV/AIDS during 2002 orth America Caribbean Latin America Western Europe orth Africa & Middle East Sub-Saharan Africa 2.4 million Eastern Europe & Central Asia East Asia & Pacific South & South-East Asia Australia & ew Zealand < million 4
5 Progress update on the global response to the AIDS epidemic, 2004 AIDS epidemic continues to expand; vulnerable populations at greatest risk Sub-Saharan Saharan Africa is most heavily affected diverse epidemics are under way in Eastern Europe and Central Asia. Injecting drug use is the main driving force behind epidemics across the region. In many high-income income countries, sex between men plays an important role in the epidemic. Drug injecting accounted for more than 10% of all reported HIV infections in Western Europe Source: UAIDS 5
6 Progress update on the global response to the AIDS epidemic,
7 Leading causes of death in Africa, 2001 Rank % of total 1 HIV/AIDS 2 Acute lower respiratory infections 3 Malaria 4 Diarrhoeal diseases 5 Perinatal conditions 6 Measles 7 Tuberculosis 8 Cerebrovascular disease 9 Ischaemic heart disease 10 Maternal conditions Source: The World Health Report 2000, WH
8 atural History of HIV disease 8
9 HIV-1 Life Cycle 1 Life Cycle 9
10 HIV Receptors 10
11 Mucosal Entry HIV Mucosal Entry HIV 11
12 HIV Binding 12
13 HIV Drug Targets HIV Drug Targets 13
14 HIV Therapeutic Possibilities 14
15 AIDS definition - CDC CD4 < 200 / mm3 or AIDS-defining illness Candidiasis Cervical cancer Coccidiodomycosis Cryptococcosis Cryptosporidiosis CMV HSV > 1 month Histoplasmosis HIV-related dementia HIV wasting Isoporosis Kaposi s sarcoma Burkitts Lymphoma H Lymphoma MAI - disseminated MTb ocardia PCP Bacterial PA (>2 in 12 mos) PML Salmonella septicemia Strongyloidosis Toxoplasmosis 15
16 WH Staging System Clinical Stage I Aysmptomatic Persistent Generalized Lymphadenopathy Performance scale - 1 Clinical Stage II Weight loss < 10% body wt Minor skin manifestations HSV recurrent URI Performance scale- 2 Clinical Stage III Weight loss > 10% body wt Chronic diarrhea Fever Thrush, HL, Pulmonary TB Severe bacterial infections Performance scale - 3 Clinical Stage IV AIDS by CDC definition HIV wasting syndrome Disseminated mycosis HIV encephalopathy Performance scale
17 Primary HIV Infection 17
18 Varicella-Zoster Infection 18
19 ral Candidiasis(Thrush) vs. ral Hairy Leukoplakia (HL) 19
20 AIDS related Tuberculosis 20
21 Pneumocystis Carinii Pneumonia 21
22 Cerebral Toxoplasmosis:CAT :CAT-SCA 22
23 Kaposi Sarcoma 23
24 Cerebral Toxoplasmosis: : MRI 24
25 Prevention vs. Rx 25
26 Prevalence among pregnant women, outside major urban areas, Uganda HIV Prevalence (%) Source: Uganda ational AIDS Programme 26
27 HIV prevalence and reported consistent condom use among female sex workers, Abidjan, Côte d'ivoire, % HIV seropositive HIV prevalence Reported consistent condom use % consistent condom use Source: Ghys PD et al. (2002) AIDS 27
28 Patent Rights vs. Patient Rights 28
29 29
30 SIDA et pharmaciens Pharmacists have assumed an increasingly important role in monitoring and fine-tuning HIV drug therapy for maximal effectiveness. 30
31 HIV REPLICATIVE CYCLE 1. Virus adsorption 2. Virus-cell fusion 3. Virus uncoating 4. Reverse transcription 5. Proviral DA integration 6. Proviral DA replication 7. Proviral DA transcription to viral mra 8. Viral mra translation to viral precursor proteins 9. Maturation (proteolysis/myristoylation/glycosylation) 10. Budding (Assembly/Release) 31
32 VIRUS ADSRPTI J. Cohen, Science 274, 502 (1996) 32
33 Suramin 3 S H C C H S 3 S 3 CH 3 H 3 C 3 S 3 S H C H C S 3 H C H 33
34 Broder et al., Lancet ii, (1985) 34
35 HIV REPLICATIVE CYCLE 1. Virus adsorption 2. Virus-cell fusion 3. Virus uncoating 4. Reverse transcription 5. Proviral DA integration 6. Proviral DA replication 7. Proviral DA transcription to viral mra 8. Viral mra translation to viral precursor proteins 9. Maturation (proteolysis/myristoylation/glycosylation) 10. Budding (Assembly/Release) 35
36 VIRUS-CELL FUSI J. Cohen, Science 274, 502 (1996) 36
37 H 3 C H Cl - CH 3 + CH 3 TAK-779 Br SCH-C (SCH ) 37
38 Inhibiteur de fusion: l'enfuvirtide 38
39 Inhibiteur de fusion: l'enfuvirtide The extracellular domain of gp41 contains a fusion peptide (FP) and 2 helical regions (HRs), HR1 and HR2. The FP region is made up of hydrophobic, glycine-rich residues essential for initiation of penetration into target cell membranes [1, 3, 4]. When fusion occurs, FP inserts into the target cell membrane, and HR1 and HR2 alter their conformation to form a 6-helix structure. The process results in the formation of a fusion pore through which the HIV capsid passes into the CD4+ cell. Cervia & Smith, Clinical Infectious Diseases 2003;37:
40 Inhibiteur de fusion: l'enfuvirtide EF is a synthetic peptide corresponding to the 36-aa sequence of the HR2 domain in gp41. EF binds to the HR1 domain in the gp41 subunit of the viral envelope protein, which prevents the formation of the 6-helix structure and interferes with the conformational changes required for membrane fusion. EF, in effect, binds to a structural intermediate of the fusion process, which impedes the transition of gp41 into a fusion-active state Cervia & Smith, Clinical Infectious Diseases 2003;37:
41 Clinical uses of entifurvide must be used in combination with other antiretrovirals lack a bioavailable oral formulation (repeated subcutaneous injections are necessary) Therefore, use is restricted to patients with advanced disease who have few remaining antiretroviral treatment options (deep- salvage therapy) Cervia & Smith, Clinical Infectious Diseases 2003;37:
42 HIV REPLICATIVE CYCLE 1. Virus adsorption 2. Virus-cell fusion 3. Virus uncoating 4. Reverse transcription 5. Proviral DA integration 6. Proviral DA replication 7. Proviral DA transcription to viral mra 8. Viral mra translation to viral precursor proteins 9. Maturation (proteolysis/myristoylation/glycosylation) 10. Budding (Assembly/Release) 42
43 HIV REPLICATIVE CYCLE 1. Virus adsorption 2. Virus-cell fusion 3. Virus uncoating 4. Reverse transcription 5. Proviral DA integration 6. Proviral DA replication 7. Proviral DA transcription to viral mra 8. Viral mra translation to viral precursor proteins 9. Maturation (proteolysis/myristoylation/glycosylation) 10. Budding (Assembly/Release) 43
44 HIV Reverse Transcriptase p66 Binding site for RTIs and trtis Binding site for RTIs 44
45 H CH 3 H 3 Zidovudine 3 -Azido-2,3 -dideoxythymidine AZT 45
46 H CH 3 H H H 2,3 -Didehydro- 2,3 -dideoxythymidine D4T Didanosine 2,3 -Dideoxyinosine DDI 46
47 H 2 H 2 H H 2 H S H H Lamivudine 2,3 -Dideoxy- 3 -thiacytidine 3TC Zalcitabine 2,3 -Dideoxycytidine DDC Abacavir 1592U89 47
48 Mechanism of action of 2,3 -dideoxynucleoside analogues, as exemplified for AZT 48
49 H 2 F H 2 H 2 F H S H S H S Emtricitabine 2,3 -dideoxy- 3 -thia-5-fluorocytidine (-)FTC (±)2 -deoxy- 3 -oxa-4 - thiacytidine (dtc) FdTC 49
50 H 2 H 2 R R H H P H H P CH 3 R = H : PMEA adefovir R = H : (R)-PMPA tenofovir 50
51 Mechanism of action of adefovir (PMEA) Similar mechanism of action applicable to tenofovir (PMPA) 51
52 H 2 (CH 3 ) 2 CH (CH 3 ) 2 CH C C CH 2 CH 2 P CH 3 fumarate bis(pc)-pmpa Tenofovir disoproxil Viread 52
53 HIV Reverse Transcriptase p66 Binding site for RTIs and trtis Binding site for RTIs 53
54 U-90152S CH 3 CH 3 CH 3 CH Delavirdine S 2 H H CH 3 H CH 3 S 3 H Cl F 3 C evirapine BI-RG-587 H Benzoxazinone Efavirenz 54
55 Structures of classical RTI s,... nevirapine efavirenz Pauwels - HIV Dart 2002 December 15-19, aples, Florida 55
56 HIV RT genetic variability after drug pressure ( = 30,000) % Pauwels - HIV Dart 2002 December 15-19, aples, Florida 56
57 HIV REPLICATIVE CYCLE Virus adsorption Virus-cell fusion Virus uncoating Reverse transcription Proviral DA integration Proviral DA replication Proviral DA transcription to viral mra Viral mra translation to viral precursor proteins Maturation (proteolysis/myristoylation/glycosylation) Budding (Assembly/Release) 57
58 Processing of peptide synthetized by the HIV genome Retrovirally encoded proteases are responsible for the maturation of immature viral particles yielding mature, infectious virus. This is done by self-activation of the protease (PR) from a larger viral gag-pr-(pol) protein (zymogen) precursor and subsequent processing of the viral reverse transcriptase (RT) and integrase (I), and the gag protein precursor into mature gag proteins. Blocking this proteolytic process results in production of immature, non-infective virions. All retroviral proteases are aspartic-type proteases and act on a Phe-Pro scissile bond of the gag/pol gene polyprotein product. 58
59 Lien Phe-Pro Pro et aspartate protease... 59
60 Mechanism of aspartate protease and typical inhibitor (pepstatin) Pepstatine... 60
61 H 3 C S CH 3 H 3 C CH 3 H H H H S CH 3 Ritonavir 61
62 CH 3 S 2 H H H H 2 H Saquinavir H 3 C H CH 3 CH 3 H 3 C H H CH 3 CH 3 H H Indinavir H 3 C CH 3 CH3 CH 3 S H H H CH 3 S 2 H CH 3 CH 3 H H H H 3 C CH 3 H elfinavir Lopinavir 62
63 HIV protease HIV protease 63
64 HIV protease HIV protease 64
65 HIV protease HIV protease 65
66 HIV protease HIV protease 66
67 HIV protease HIV protease 67
68 MUTATIS I THE HIV PRTEASE GEE ASSCIATED WITH REDUCED SUSCEPTIBILITY T PRTEASE IHIBITRS (PIs) 68
69 HIV protease gene diversity matrix Pauwels - HIV Dart 2002 December 15-19, aples, Florida 69
70 HIV protease genetic variability after PI drug pressure ( = 30,000) % Pauwels - HIV Dart 2002 December 15-19, aples, Florida 70
71 Interférences médicamenteuses et inhibiteurs de protéase Cette protéase doit scinder un lien Phe- Pro Les inhibiteurs miment donc tous une Phe R 1 R 3 C C H H C H 2 C H H 2 C C R 2 R 4 H R 5 71
72 Métabolisme des substances à noyau aromatique La plupart des médicaments (et autres substances) à noyau aromatique sont métabolisées en dérivés hydroxylés, ce qui est essentiel pour leur élimination R 3 R R R C H H 2 C H H 2 C R 4 H R 5 H phénytoïne (antépileptique) phénobarvital (sédatif) propranolol (antihypertenseur) phénylbutazone (antiinflammatoire) éthinyloestradiol (hormone) dicoumarol (anticoagulant).. Par leur noyau aromatique (essentiel pour l'activité!!), les inhibiteurs de protéase entrent en compétition avec ces médicaments (et bien d'autres) il vont ralentir leur élimination, et, dès lors créer un risque d'intoxication par excès 72
73 RTIs Zidovudine Didanosine Zalcitabine Stavudine Lamivudine Abacavir RTIs evirapine Delavirdine Efavirenz PIs Saquinavi r Ritonavir Indinavir elfinavir Amprenav ir Lopinavir 73
74 RTIs Zidovudine Didanosine Zalcitabine Stavudine Lamivudine Abacavir trtis Tenofovir RTIs evirapine Delavirdine Efavirenz PIs Saquinavir Ritonavir Indinavir elfinavir Amprenavir Lopinavir 74
75 Anti-retroviral Therapy (ART): When to initiate treatment - CDC Guidelines Clinical Category CD4 count HIV RA VL Recommendation Symptomatic/AIDS Any value Any value Treat Asymptomatic <200 /mm3 Any value Treat AIDS Aymptomatic /mm3 Any value ffer treatment; controversial Aymptomatic > 350 /mm3 >55,000 Some would initiate or follow CD4/VL closely Aysmptomatic >350 /mm3 <55,000 Many defer and observe as 3 yr risk AIDS <15% Acute HIV infection Any value Any value ffer treatment 75
76 Anti-retroviral Therapy (ART): When to initiate treatment - WH guidelines WH stage IV (AIDS-defining diagnosis), regardless of CD4 count CD4 available: WH stage I,II,III and CD4 <200 cells/mm3 CD4 not available: WH stage II,III (symptomatic HIV) plus absolute lymphocyte count <1200/mmm3 76
77 Anti-retroviral Therapy (ART): Goals of Treatment Decrease viral load ( log10) within 4 weeks or Decrease in viral load 1 log 10 in 8 weeks Undetectable VL (<50 or <20 copies) at 4-64 months Restoration or preservation of immune function Reduction of HIV related morbidity and mortality 77
78 Anti-Retrovirals ucleoside Reverse Transcriptase Inhibitors (srtis) Drug CDC Group Dose Side Effects Abacavir (ABC) Group A 300 mg bid Hypersensitivity rxn, fever, rash, lactic acid Zidovudine (AZT, ZDV) Group B 200 mg tid 300 mg bid BM supp, anemia, GI, LA, HA,insomnia Stavudine (d4t) Group B 40 mg bid 30 mg bid Pancreatitis, LA w/ steatohep, neuropathy Lamivudine (3TC) Group B 150 mg bid LA w/ steatohepatitis Didanosine (ddi) Group B 200 mg bid, 400 mg qd 125 mg bid, 250 mg qd Pancreatitis, neuropathy, GI, LA w/ steatohepatitis Zalcitabine (ddc) Group B 0.75 mg qd europathy, stomatitis, LA 78
79 Anti-Retrovirals ucleoside Reverse Transcriptase Inhibitors (RTIs) Drug Brand Dose Side Effects AZT + 3TC Combivir 1 tab bid Same as AZT, 3TC AZT + 3TC + ABC Trizivir 1 tab bid Same as AZT, 3TC, ABC ucleotide Reverse Transcriptase Inhibitors (trtis) Tenofovir (TDF) Group A 300 mg qd o renal toxicity; limited expanded access 79
80 Anti-Retrovirals on-nucleotide nucleotide Reverse Transcriptase Inhibitors (RTIs) Drug Brand Dose Side Effects Efavirenz (EFV) Sustiva 600 mg qhs Rash, CS, hepatitis, induce, inhibits P450 evirapine (VP) Viramune 200 mg bid Rash, elevated LFTs, hepatitis, induce P450 Delavirdine (DLV) Rescriptor 400 mg tid Rash, elevated LFTs, HA, inhibits P450 80
81 Anti-Retrovirals Protease Inhibitors (PIs) Drug Brand Dose Side Effects Saquinavir (SQV) Inivirase 400 mg bid w/ ritonavir GI intolerance, /D/HA Saquinavir (SQV) Fortovase 1200 mg tid Elevated LFTs, fat redistn, DM Ritonavir (RTV) orvir 600 mg q12 GI, /V/D, hepatitis, pancreatitis, incr lipids, DM, fat redistn, neuro elfinavir (FV) Viracept 1250 mg bid 750 mg tid D/, DM, Fat redistn, Lipids abnl Indinavir (IDV) Crixivan 800 mg q8h ephrolithiasis, GI intol,, HA, incr LFTs, DM, fat redistn Lopinavir + Ritonavir Kaletra 400 mg lop+ 100 mg rit bid GI, /V/D, DM, fat redistn, elevated LFTs Amprenavir (APV) Agenerase 1200 mg bid GI, /V/D, rash, DM, fat redistn, LFTs, Lipid 81
82 Anti-Retrovirals Retrovirals: Strongly Recommended Regimens Group A Efavirenz Indinavir elfinavir Ritonavir + Indinavir Ritonavir + Lopinavir Ritonavir + Saquinavir Group B Didanosine + Lamuvidine Stavudine + Didanosine Stavudine + Lamuvidine Zidovudine + Didanosine Zidovudine + Lamivudine 82
83 Anti-Retrovirals CDC Recommended Regimens Combine one from Group A and one from Group B o mono or dual therapies Class sparing regimens: 2 RTIs + RTI 3 RTIs 2 RTIs + 1 or 2 PIs If previous treatment, consider resistance testing prior to initiating treatment 83
84 Anti-retroviral Therapy: WH Guidelines for Resource Limited Settings srtis trtis RTIs PIs Zidovudine (ZDV, AZT) Tenofovir (TDF) evirapine (VP) Saquinavir (SQV) Didanosine (ddi) Efavirenz (EFV) Ritonivir (RTV) Stavudine (d4t) Lamivudine (3TC) Abacavir (ABC) Indinavir (IDV) elfinavir (FV) Lopinavir/ritonavir (LPV/r) 84
85 Anti-retroviral Therapy (ART): First Line agents in resource limited settings 2 nucleoside analogs + RT or PI Examples starting regimen: Abacavir regimen: AZT/3TC/ABC trizavir - one pill bid RTI regimen: AZT/3TC/EFZ or AZT/3TC/ VP (VP in pregnancy) PI regimen: AZT/3TC + one of IDV/RTV, SQV/RTV, or FV 85
86 Prevention of Mother-to to-child Transmission: Resource Limited Settings Short course ARV regimens for prevention of MTCT can be associated with ARV resistance Most often seen with evirapine and 3TC Suggested Regimens: AZT or AZT/3TC - continued through delivery evirapine - one dose to mother & child PIs do not cross placenta d4t/ddi not recommended during pregnancy due to side effects (lactic acidosis/steatohepatitis) 86
87 ne-on on-one one support Antiretroviral Therapy Adherence Support Counselling Treatment assistant (self-selected) selected) Home visits Peer support Support groups composed of people on ART Adherence materials Pill box (with customized packing instructions) Daily schedule Self-monitoring form 87
88 Antiretroviral Therapy Adherence Support 88
89 pportunistic Infections & Complications by CD4 Count CD4 Count Infectious on-infectious > 500/mm3 Acute HIV Candidal vaginitis / mm3 Pneumococcal PA Pulm Tb Zoster Thrush Crytosporidiosis KS HL PGL GBS Myopathy Aseptic meningitis CI Cervical Cancer B-cell Lymphoma Anemia Mononeuronal multiplex ITP Hodkin s Lymphoma LIP 89
90 pportunistic Infections & Complications by CD4 Count CD4 Count Infectious on-infectious < 200/mm3 P. carinii pneumonis Disseminated mycoses Miliary /extrapulm Tb PML < 100/mm3 Disseminated HSV Toxoplasmosis Crytococcosis Cryptosporidiosis Microsporidiosis Candidal esophagitis < 50/mm3 Disseminated CMV Disseminated MAI Wasting Peripheral neuropathy HIV dementia Cardiomyopathy Vacuolar myelopathy Polyradiculopathy H Lymphoma CS lymphoma 90
91 Primary Prophylaxis of pportunistic Infections Pathogen Indication First agent Alternative Pneum. Cyst. C. MTb MTb (IH resistant) Toxo CD4<200 PPD > 5 mm Exposure PPD > 5 mm IgG Ab + & CD4<100 Cotrimox.1 DS qd or 1 SS qd IH B6 x 9 m Rifampin 600 qd Rifabutin 300 qd Cotrimox.1 DS qd MAI CD4<50 Azithromycin 1200 qw Clarithromycin 500 bid Zoster Exposure VZIG 5 vials within 96 hours Dapsone 100 qd Dapsone 50 + pyrimethamine + leuco Atovaquone 1500/day Rifampin 600 qd x 4 m Pyrazinamide + rifampin or rifabutin Bactrim 1 SS qd, Dapsone+ pyrimethamine+ leuvovorin Rifabutin, azithro + rifabutin - 91
92 Primary & Secondary Prophylaxis of pportunistic Infections Pathogen Indication First agent Alternative Strep PA CD4<200 Pneumovax HBV HbsAb neg HBV vaccine x 3 Influenza ct-dec Flu vaccine Anti-virals HAV HAV negative + risk HAV vaccine x 2 Crypto Fluconazole 200 qd Itraconazole 200 bid Histo Intraconazole 200 qd Coccidio Fluconazole 400 qd Itraconazole 200 bid CMV Consult expert 92
93 I Prophylaxis in Resource Limited Settings Pneumocystis Carinii Pneumonia & Toxoplasma Cotrimoxazole 1 DS or 1 SS qd Recurrent Bacterial PA and Infections Cotrimoxazole 1 DS or 1 SS qd Mycoses (ie Cryptococcus) when CD4<100 Fluconazole 200 mg qd Esophageal Candidiasis Fluconazole 200 mg qd Mycobacterium Tb PPD, Chest X-rayX IH 300 mg po qd + B6 x 9 months or short regimens 93
94 Web Resources WH - Expanded Access to HIV/AIDS treatment STI treatment s_ / JHU Medical Management of HIV abbrevgd/abbrevgd.pdf CDC/USPHS Guidelines 94
95 References WH/UAIDS. A commitment to Action for Expanded Access to HIV/AIDS Treatment. December 2002 WH/UAIDS. Scaling up Antiretroviral Therapy in Resource-Limited Settings. December 2002 CDC/USPHS. Guidelines for Using Antiretrovrial Agents Among HIV Infected Adults and Adolescents. May 2002 Bartlett JG, Gallant JE. Johns Hopkins University School of Medicine Medical Management of HIV Infection Hammer S. M. Increasing Choices for HIV Therapy. Engl J Med 2002; 346: , Jun 27, 2002 Steinbrook R.Beyond Barcelona The Global Response to HIV Engl J Med 2002; 347: , Aug 22,
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