STATE OF THE ART OF THE TREATMENT OF HIV INFECTIONS (AIDS)

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1 STATE F THE ART F THE TREATMET F HIV IFECTIS (AIDS) Erik De Clercq Rega Institute for Medical Research, K.U.Leuven B-3000 Leuven, Belgium

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4 Leading causes of death in Africa, % of Total HIV/AIDS Malaria Perinatal conditions Lower respiratory infections Diarrhoeal disease Measles Tuber culosis Ischaemic Heart disease Cerebro vascular disease Maternal conditions Source: The World Health Report 2001, WH

5 HIV REPLICATIVE CYCLE

6 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)

7 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)

8 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

9 Broder et al., Lancet ii, (1985)

10 Polyanions CH 2 H H H 3 S S 3 H H S 3 Dextran sulfate n CH 2 CH CH 2 CH H - S 3 l PVAS m CH 2 CH CH 2 S 3 - PVS S 3 - CH n CH 2 CH CH 2 CH CH 2 CH CH 2 C 2 - k H l S 3 - m S 3 - PAVAS PR 2000 n

11 (H 2 )Leu Gly Lys Phe Ser Gln Thr Cys Tyr Asn Ser Ala Ile Gln Gly Ser Val Leu Thr Ser Thr Cys Glu Arg Thr Asn Gly Gly Tyr Asn Thr Ser Ser Ile Asp Leu Asn Ser Val Ile Glu Asn Val Asp Gly Ser Leu Lys Trp Gln Pro Ser Asn Phe Ile Glu Thr Cys Arg Asn Thr Gln Leu Ala Gly Ser Ser Glu Leu Ala Ala Glu Cys Lys Thr Arg Ala Gln Gln Phe Val Ser Thr Lys Ile Asn Leu Asp Asp His Ile Ala Asn Ile Asp Gly Thr Leu Lys Tyr Glu(CH) Cyanovirin-

12 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)

13 HIV FUSI STEPS

14 AMD 3100 H H H H AMD 3329 H H H H H H AMD 2763 H H H H H H AMD 1657 AMD 3479 H H H H H H H H H H M H H H H H H M

15 Fusion peptide Leucine zipper region H 2 C C Membrane spanning region DP-107 DP amino acids CH YTSLIHSLIEESQQQEKEQELLELDKWASLWWF T-20 (Pentafuside, Enfuvirtide, Fuzeon)

16 MUTATIS I THE GP41 EVELPE GEE ASSCIATED WITH RESISTACE T ETRY IHIBITRS

17 T-20 (enfuvirtide) versus ptimized Regimen nly (TR 1) Study 1 Efficacy at week 24 in the Intention-to-Treat population Variable Enfuvirtide group Control group P value Least-squares mean change from base line in plasma HIV-1 RA level (log 10 copies/ml) <0.001 <50 Copies of HIV-1 RA per ml of plasma (% of patients) <0.001 <400 Copies of HIV-1 RA per ml of plasma (% of patients) <0.001 Reduction from base line of 1 log 10 copies of HIV-1 RA per milliliter of plasma (% of patients) <0.001 Least-squares mean increase in CD4+ cell count (cells/µl) <0.001 Patients from 48 sites in orth and South America with at least six months of previous treatment with antiretroviral drugs, and with 5000 copies of HIV-1 RA per ml of plasma were assigned in a 2:1 ratio to receive enfuvirtide plus an optimized background regimen of 3 to 5 antiretroviral drugs or such regimen alone (control group). Enfuvirtide (90 mg) was administered twice daily by subcutaneous injection. Lalezari et al.,. Engl. J. Med. 348 (29 May 2003)

18 T-20 (enfuvirtide) versus ptimized Regimen nly (TR 1) Study 1 Time to protocol-defined virologic failures, as of week 24 Lalezari et al.,. Engl. J. Med. 348 (29 May 2003)

19 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)

20 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)

21 HIV Reverse Transcriptase p66 Binding site for RTIs and trtis Binding site for RTIs

22 H CH 3 H 3 Zidovudine 3 -Azido-2,3 -dideoxythymidine AZT Retrovir

23 H H Didanosine 2,3 -Dideoxyinosine DDI Videx

24 H 2 H Zalcitabine 2,3 -Dideoxycytidine DDC Hivid

25 H CH 3 H Stavudine 2,3 -Didehydro-2,3 -dideoxythymidine D4T Zerit

26 H 2 H S Lamivudine 2,3 -Dideoxy-3 -thiacytidine 3TC Epivir

27 H H 2 H Abacavir 1592U89 Ziagen

28 H 2 F H S Emtricitabine 2,3 -dideoxy-3 -thia-5-fluorocytidine (-)FTC Coviracil TM

29 H 2 H H H 2 H H 2 DAPD Amdoxovir DXG

30 H 2 H S (±)2 -deoxy-3 -oxa-4 -thiacytidine (dtc)

31 H 2 F H S (±)2 -Deoxy-3 -oxa-4 -thiocytidine (FdTC) Racivir (RCV)

32 H 2 F H DPC 817 D-D4FC Reverset

33 H 2 F H Elvucitabine (ACH-126,443) β-l-2,3 -didehydro-2,3 -dideoxy-5-fluorocytidine (β-l-d4fc)

34 H CH 3 H F Alovudine (MIV-310) 3 -Fluoro-2,3 -dideoxythymidine FddTdhd

35 MUTATIS I THE REVERSE TRASCRIPTASE GEE ASSCIATED WITH REDUCED SUSCEPTIBILITY T UCLESIDE REVERSE TRASCRIPTASE IHIBITRS (RTIs)

36 H 2 H 2 H 2 R R R H H P H H P CH 2 F H H P CH 3 R = H : PMEA R = H 2 : PMEDAP R = H : (S)-FPMPA R = H 2 : (S)-FPMPDAP R = H : (R)-PMPA R = H 2 : (R)-PMPDAP

37 H 2 (CH 3 ) 3 C (CH 3 ) 3 C C C CH 2 CH 2 P bis(pm)-pmea Adefovir dipivoxil

38 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

39 MUTATIS I THE REVERSE TRASCRIPTASE GEE ASSCIATED WITH REDUCED SUSCEPTIBILITY T UCLETIDE REVERSE TRASCRIPTASE IHIBITRS (trtis)

40 HIV Reverse Transcriptase p66 Binding site for RTIs and trtis Binding site for RTIs

41 CH 3 H evirapine BI-RG-587 Viramune

42 CH 3 CH 3 CH 3 CH S 2 H H CH 3 S 3 H U-90152S Delavirdine Rescriptor

43 Cl F 3 C H Benzoxazinone DMP 266 Efavirenz Sustiva

44 CH 3 H CH 3 H 3 C MKC-442 Emivirine Coactinon

45 Cl S H 2 Cl H 3 C CH 3 S-1153 AG1549 Capravirine

46 Cl F 3 C H H DPC-083

47 H (+)-Calanolide A

48 S C CH 3 H Cl CH 2 CH C CH 3 CH 3 UC-781

49 H Br H 2 R TMC-125 Dapivirine

50 Activity in treatment-naive patients TMC mg b.i.d. monotherapy x 7 days (mean ± SE) Log viral load (cps/ml plasma) Time (days) o treatment Treatment: TMC125 or Pbo Pauwels - HIV Dart 2002 December 15-19, aples, Florida

51 TMC125: viral load response in individual patients (n = 12) 5 Log viral loads (cps/ml plasma) 400 cps/ml LD: 50 cps/ml Mean VL : log Screening Time (days) Pauwels - HIV Dart 2002 December 15-19, aples, Florida

52 MUTATIS I THE REVERSE TRASCRIPTASE GEE ASSCIATED WITH REDUCED SUSCEPTIBILITY T UCLESIDE REVERSE TRASCRIPTASE IHIBITRS (RTIs)

53 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)

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55 F H H S-1360

56 S F H H 1,6-aphthyridine-7-carboxamide L

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)

58 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)

59 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)

60 gag pol Direct translation Frameshift translation Pr55 gag My p17 p24 p9 p6 Pr160 gag-pol My p17 p24 p15 protease reverse transcriptase R endonuclease

61 Proteolytic cleavage site Substrate (Peptidic bond) (Leu) (Phe) (Ile) (Ser) Ser Gln Asn Tyr Pro Val Val Scissile bond H C Inhibitor (Hydroxyethylene bond) on-scissile bond C H H

62 (Leu) (Phe) (Ile) (Ser) Gln Asn Tyr Pro Val Val Substrate H peptidic bond Inhibitor H H hydroxyethylene bond Saquinavir Ritonavir Indinavir elfinavir Amprenavir Lopinavir

63 H H H 2 H CH 3 S 2 H H 3 C H CH 3 CH 3 Saquinavir Invirase

64 H 3 C S CH 3 H 3 C CH 3 H H H H S CH 3 Ritonavir orvir

65 H H H H H 3 C CH 3 CH 3 Indinavir Crixivan

66 H 3 C CH 3 CH3 H CH 3 S H H H CH 3 S 2 H elfinavir Viracept

67 S H H CH 3 H 2 CH 3 Amprenavir Agenerase

68 S H H P CH 3 H CH 3 H 2 Fosamprenavir

69 CH 3 H H H H CH 3 H 3 C CH 3 Lopinavir Kaletra

70 H H H H H BMS Atazanavir

71 Atazanavir clinical profile nce-daily azapeptide PI Low pill burden (2 capsules/day) Efficacy and durability of response in treatment-naive and experienced patients Atazanavir treatment does not result in clinically relevant increases in total cholesterol, low-density lipoprotein cholesterol, or triglycerides Atazanavir does not inhibit insulin-mediated transport of glucose I50L is signature mutation in PI-naive patients, and is associated with increased in vitro sensitivity to other PIs Colonno et al., Antiviral Ther. 7 (Suppl. 1): S6 (2002)

72 Atazanavir (ATV) qd versus efavirenz (EFV) qd with zidovudine plus lamivudine bid in treatment-naive patients Virologic response through week 48 (ITT) 100 ATV (=404) EFV (=401) Responders (%) B/L <400 c/ml <50 c/ml Week Squires et al., 42 nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Diego, CA, USA, September Abstract no. H-1076

73 Susceptibility profiles of I50L isolates Susceptibility (fold change) AT = AP = ID = LP = F = RT = SQ = Atazanavir Amprenavir Indinavir Lopinavir elfinavir Ritonavir Saquinavir 0.0 AT AP ID LP F RT SQ Protease Inhibitors Colonno et al., 10 th Conference on Retroviruses and pportunistic Infections, Boston, MA, USA, February Abstract no 597

74 H 2 H 2 H H DMP-450 Mozenavir

75 H 3 C H CH 3 H S F PU Tipranavir F F

76 MUTATIS I THE HIV PRTEASE GEE ASSCIATED WITH REDUCED SUSCEPTIBILITY T PRTEASE IHIBITRS (PIs)

77 Drugs used to treat HIV infections (AIDS) Drug Brand ame Manufacturer ucleoside reverse transcriptase inhibitors (RTIs) Zidovudine (AZT) Retrovir GlaxoSmithKline Didanosine (ddi) Videx Bristol-Myers Squibb Zalcitabine (ddc) Hivid Roche Stavudine (d4t) Zerit Bristol-Myers Squibb Lamivudine (3TC) Epivir GlaxoSmithKline Abacavir (ABC) Ziagen GlaxoSmithKline ucleotide reverse transcriptase inhibitors (trtis) Tenofovir disoproxil fumarate (TDF) Viread Gilead Sciences on-nucleoside reverse transcriptase inhibitors (RTIs) evirapine Viramune Roxane/Boehringer Ingelheim Delavirdine Rescriptor Pharmacia Efavirenz Sustiva, Stocrin DuPont Merck Protease inhibitors (PIs) Saquinavir Fortovase, Invirase Roche Ritonavir orvir Abbott Indinavir Crixivan Merck elfinavir Viracept Agouron/Pfizer Amprenavir Agenerase GlaxoSmithKline Lopinavir (with ritonavir) Kaletra Abbott

78 Sales $m Sales of the major anti-retroviral drugs in 2001 Source: Companies, Fortis Bank

79 % total sales Share of the global HIV market by drug type from 1998 to 2001 PI RTI RTI Source: Companies, Fortis Bank

80 Currently approved RTIs Brand name Generic FDA approved Manufacturer Retrovir Zidovudine March 1987 GSK Videx Didanosine ctober 1991 BMS Hivid Zalcitabine June 1992 Roche Zerit Stavudine June 1994 BMS Epivir Lamivudine ovember 1995 GSK Combivir Zidovudine + lamivudine September 1997 GSK Ziagen Abacavir December 1998 GSK Trizivir Abacavir + lamivudine + zidovudine ovember 2000 GSK Viread Tenofovir ctober 2001 Gilead Source: Companies, Fortis Bank

81 RTIs in development ame Clinical trials Manufacturer Description Epivir + Ziagen Phase III GSK ew RTI combination tablet Coviracil DA Triangle Amdoxovir Phase II Triangle Purine (guanine) nucleoside analogue MIV-310 Phase II Medivir Thymidine mimetic; Phase IIa is complete. Additional Phase IIb trials being planned for 2003 Ach Phase I Achillion Pharma An L-nucleoside with in vitro activity against HIV and HBV. The drug is being positioned as a lamivudine (3TC) replacement Source: Companies, Fortis Bank

82 Currently approved RTIs Brand name Generic FDA approved Manufacturer Viramune evirapine June 1996 Boehringer Ingelheim Rescriptor Delavirdine April 1997 Upjohn/Pharmacia/Pfizer Sustiva Efavirenz September 1998 DuPont/BMS Source: Companies, Fortis Bank

83 RTIs in development ame Clinical trials Manufacturer Description Coactinon (MKC-442) Phase III Triangle Terminated Capravirine (AG1549) Phase III Agouron/Pfizer Appears to be 10 times more effective than nevirapine or delavirdine. HIV requires 2 or 3 mutations to become resistant to this drug (compared to 1 mutation for other RTIs). Phase III - reinitiated TMC125 Phase II Tibotec/J & J Achieved a 2-log drop in viral load within 7 days, all patients responded, and the drug was safe and well tolerated. It was active against mutant strains of HIV DPC083 Phase III DuPont/BMS A modified form of efavirenz (Sustiva) that will probably be a once daily formulation with some activity against HIV resistant to other RTIs. US submission due 2003 Calanolide A Phase I/II Sarawak Medichem ovel RTI based on a natural chemical found in a tropical rainforest tree Source: Companies, Fortis Bank

84 Currently approved PIs Brand name Generic name FDA approved Manufacturer Invirase / Fortovase Saquinavir Dec 1995/ov 1997 Roche orvir Ritonavir March 1996 Abbott Crixivan Indinavir March 1996 Merck Viracept elfinavir March 1997 Roche (ex-us sales) Pfizer (US sales) Agenerase Amprenavir April 1999 Vertex/GSK Kaletra Lopinavir (+ ritonavir) 1st quarter 2001 Abbott Source: Companies, Fortis Bank

85 PIs in development ame Clinical trials Manufacturer Description Atazanavir (BMS ) EMEA filed, Phase III US BMS nce daily dosing, pending EU approval, Phase III in the US. Expected to combine a better safety profile with increased potency Fosamprenavir (GW433908) Phase III Vertex/GSK A prodrug of amprenavir (Agenerase) in a more convenient formulation Tipranavir (PU ) Phase III Boehringer Ingelheim Better resistance profile, expected to be used for patients who have tried and failed at least on one PIbased combination DMP450 Phase II/III Triangle Terminated Source: Companies, Fortis Bank

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89 RTIs Zidovudine Didanosine Zalcitabine Stavudine Lamivudine Abacavir trtis Tenofovir RTIs evirapine Delavirdine Efavirenz PIs Saquinavir Ritonavir Indinavir elfinavir Amprenavir Lopinavir

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95 H 2 P VIREAD TM (tenofovir disoproxil fumarate)

96 Study 903 Study Design: Randomization ART-naive patients TDF EFV 3TC d4t placebo QD QD BID BID 144 wks Stratification by: ( = 600) randomized 1:1 d4t EFV 3TC BID QD BID plasma HIV RA >/< cop/ml CD 4 count >/< 200 cells/mm³ 144 wks TDF placebo QD Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17

97 Study 903 % Patients < 400 Copies/mL Missing bservations are Excluded 100 % Patients with HIV-1 RA < 400 c/ml TDF+3TC+EFV d4t+3tc+efv Weeks 96% 95% Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17

98 Study 903 % Patients < 400 Copies/mL % Patients with HIV-1 RA < 400 c/ml Intent to Treat (M=F) TDF+3TC+EFV d4t+3tc+efv Weeks Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17 87% 87%

99 Study 903 % Patients < 50 Copies/mL % Patients with HIV-1 RA < 50 c/ml Intent to Treat (M=F) 82% 81% Weeks TDF+3TC+EFV d4t+3tc+efv Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17

100 Study 903 Mean Change from Baseline in CD4 Intent to Treat Change in CD4 Cell Count TDF+3TC+EFV d4t+3tc+efv Weeks Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17

101 Study 903 ucleoside Associated Toxicities (All Grades, 0-48 Weeks) TDF+3TC+EFV (n=299) d4t+3tc+efv (n=301) Patients (%) with Events a 9 ( 3%) 34 ( 11%) Peripheral euritis/europathy 6 ( 2%) 20 ( 7%) Lipodystrophy 3 ( 1%) 11 ( 4%) Lactic Acidosis 0 3 ( <1%) Pancreatitis 0 0 Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17 a Investigator Defined

102 Study 903 Grade 3/4 Laboratory Abnormalities a (0-48 Weeks) TDF+3TC+EFV d4t+3tc+efv (n=299) (n=301) Patients (%) with Abnormalities 85 (28%) 94 (31%) Creatine Kinase 25 ( 8%) 26 ( 8%) Amylase 21 ( 7%) 18 ( 6%) AST 13 ( 4%) 16 ( 5%) Hematuria 13 ( 4%) 13 ( 4%) ALT 11 ( 3%) 11 ( 3%) Lipase 11 ( 3%) 9 ( 3%) eutropenia 9 ( 3%) 2 (<1%) Triglycerides 7 ( 2%) 24 ( 8%) Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17 a 3% in any group

103 Study 903 Mean (95%CI) Change from Baseline in Triglycerides Change from Baseline (mg/dl) d4t+3tc+efv TDF+3TC+EFV BL Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17 Wk 48, p < mg/dl 0 mg/dl Week

104 Change from Baseline (mg/dl) Study 903 Mean (95% CI) Change from Baseline in Cholesterol d4t+3tc+efv TDF+3TC+EFV Wk 48, p < mg/dl 25 mg/dl 0 BL Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17 Week

105 Study 903 Serum Creatinine Maximum Toxicity Grade (0-48 Weeks) Grade (mg/dl) TDF+3TC+EF d4t+3tc+efv (n=296) (n=296) 1 ( 0.5 from baseline) 3 ( 1%) 5 ( 2%) 2 ( ) 2 (<1%) 0 3 ( ) 0 2 (<1%) 4 (>6.0) 0 0 Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17

106 Study 903 Summary High proportions of patients in both arms achieved: HIV-RA <400 and <50 c/ml Significant increases in CD4 cell count Both arms had low discontinuation rates Compared to the control group the tenofovir DF containing group showed smaller increases in cholesterol and no change in triglyceride levels Staszewski S. XIV World AIDS Conference, Barcelona, Spain, July 7-12, 2002, Abstract Lbr17

107 Results from Clinical Trials: Percent With HIV RA 50 at 48 Weeks ITT Regimen (Trial) d4t + ddi + EMV (MKC-302) AZT + 3TC + APV (PRAB 3301) AZT + 3TC + IDV (START II) AZT + 3TC + ABC (CA3005) d4t + ddi + IDV (START II) AZT + 3TC + IDV (DMP-006) AZT + 3TC + IDV (AVATI 2) AZT + ddi + VP (ICAS) AZT + 3TC + FV (AVATI 3) AZT + 3TC + IDV (CA3005) AZT + 3TC + IDV (START I) d4t + 3TC + EMV (MKC-302) d4t + ddi + 3TC (Atlantic) d4t + 3TC + IDV (START I) d4t + ddi + VP (Atlantic) 2 RTIs + SQV-SGC (V-15355) AZT + 3TC + ABC (CAB3003) d4t + ddi + IDV (Atlantic) AZT + 3TC + EFV (DMP-006) d4t + 3TC + EFV (DMP-043) Success Rates: 25-75% Bartlett. 7th CRI; 2000; San Francisco. Poster 519.

108 Regimen (Trial) Results from Clinical Trials: Percent With HIV RA 50 at 48 Weeks d4t + ddi + EMV (MKC-302) AZT + 3TC + APV (PRAB 3301) AZT + 3TC + IDV (START II) AZT + 3TC + ABC (CA3005) d4t + ddi + IDV (START II) AZT + 3TC + IDV (DMP-006) AZT + 3TC + IDV (AVATI 2) AZT + ddi + VP (ICAS) AZT + 3TC + FV (AVATI 3) AZT + 3TC + IDV (CA3005) AZT + 3TC + IDV (START I) d4t + 3TC + EMV (MKC-302) d4t + ddi + 3TC (Atlantic) d4t + 3TC + IDV (START I) d4t + ddi + VP (Atlantic) 2 RTIs + SQV-SGC (V-15355) AZT + 3TC + ABC (CAB3003) d4t + ddi + IDV (Atlantic) AZT + 3TC + EFV (DMP-006) d4t + 3TC + EFV (DMP-043) d4t + 3TC + EFV (GS-903) TDF + 3TC + EFV (GS-903) ITT Success Rates: 25-82%

0.14 ( 0.053%) UNAIDS 10% (94) ( ) (73-94/6 ) 8,920

0.14 ( 0.053%) UNAIDS 10% (94) ( ) (73-94/6 ) 8,920 0.14 UNAIDS 0.053% 2 250 60 10% 94 73 20 73-94/6 8,920 12 43 Public Health Service Task Force Recommendations 5-10% for Use of Antiretroviral Drugs in 10-20% Pregnant HIV-1-Infected Women for Maternal

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