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HAVE WE PREMATURELY
DISCARDED TRIPLE NRTI
REGIMENS?
YES
Diane V. Havlir, MD
University of California, San Francisco, USA
Available and emerging data suggest that
select triple NRTI regimens are:
•Simple to administer
•Associated with respectable HIV RNA reductions
and CD4 increases
•Safe
•Favorable drug interaction profile
ZDV + 3TC + ABC
ZDV + 3TC + TDF
From a global perspective, these combinations may
represent some of the best options in some rather large
populations:
•HIV+TB
•Women
• Child bearing age, pregnant
•Breastfeeding
•Persons with HIV-2
HIV and TB: How large is
this problem?
•4 fold increase in TB in
some parts of Africa
•50-70% TB cases HIV+
•Case fatality rates 20%
smear +, 50% smear –
•Mean CD4 may be lower
than previously thought
•Lower penetration of ART in
TB patients than meet
treatment criteria
AT HIGH RISK FOR TB,
AND WILL NEED TB AND HIV TREATMENT
HAVE CONFIRMED OR SUSPECTED
TB,AND NEED TB AND HIV TREATMENT
OR
Antiretroviral Treatment Challenges with HIV
and TB: Drug Interactions and Toxicity
• Rifamycin containing regimens are associated with
best TB treatment outcome.
• Rifampin is the only affordable rifamycin option in
most of the world.
• Rifampin has significant drug interactions with
NNRTIs and PIs.
• Drug toxicity may be higher when rifampin is
administered with NNRTIs or ritonavir boosted-
PIs.
Regimen
Nevirapine +2 NRTI
Disadvantages
Decrease in NVP by rifampin
Cannot give if CD4 >250 in women
Hepatoxicity
Rash
FIRST LINE HIV TREATMENT REGIMENS*
*WHO Guidelines for Resource Limited Settings
March 2005: Severe, life threatening and
sometimes fatal hepatoxicity in the first 18
weeks has been reported in patients treated
with viramune. Women with CD4> 250
cells/mm3 are at greatest risk.
Regimen
Nevirapine +2 NRTI
Efavirenz+2 NRTI
Disadvantages
Decrease in NVP by rifampin
Cannot give if CD4 >250 in women
Hepatoxicity
Rash
Decrease in EFV by rifampin
Teratogenic
FIRST LINE HIV TREATMENT REGIMENS*
March 2005: Severe, life threatening and
sometimes fatal hepatoxicity in the first 18
weeks has been reported in patients treated
with viramune. Women with CD4> 250
cells/mm3 are at greatest risk.
March 2005: SUSTIVA may cause fetal harm when
administered during the first trimester to a pregnant
woman, pregnancy should be avoided in women receiving
SUSTIVA
*WHO Guidelines for Resource Limited Settings
Regimen
PI +2 NRTI
Boosted PI +2 NRTI
Disadvantages
PI levels decrease by >70%,
cannot use
Toxicity
Drug interactions
Cost
Cold chain /Refrigeration
ALTERNATIVE REGIMENS
Ritonavir-Saquinavir and Rifampin
interaction
• Recent drug interaction warning issued
• HIV- volunteers received 100/1000 rit/SQV and rifampin
600 mg
• Study stopped prematurely
• 39% developed hepatocellular toxicity
• Elevations up to 20 times upper normal of limit of liver tests
were observed
Rifampin SHOULD NOT be administered to patients receiving
saquinavir/ritonavir as part of combination antiretroviral therapy
for HIV infection*
*Roche, Dear Doctor letter, Feb , 2005
TRIPLE NRTI REGIMEN FOR PATIENTS
RECEIVING TB TREATMENT
ZDV + 3TC + ABC
ZDV + 3TC + TDF
ADVANTAERegimen Advantage
•NO DRUG INTERACTIONS WITH TB MEDS
•NOT TERATOGENIC
•LESS RISK THAN NNRTI FOR HIV
RESISTANCE WITH TREATMENT
INTERRUPTIONS
•FAMILY BASED CARE
•NO DRUG INTERACTIONS WITH TB
MEDS
•NO RASH
•LESS RISK THAN NNRTI FOR HIV
RESISTANCE WITH TREATMENT
INTERRUPTIONS
WOMEN: SIGNIFICANT LIMITATIONS OF FIRST
LINE REGIMENS
Courtesy of Dr. El Sadr
1. Women at risk for pregnancy who need
ART
2. Pregnant and breastfeeding women who
need ART
3. Pregnant and breastfeeding women who
need ART to prevent perinatal transmission
only
4. Women who need chronic ART who harbor
nevirapine resistant virus
SIGNIFICANT LIMITATIONS OF FIRST LINE
REGIMENS : 4 GROUPS
PREGNANCY RISK PREGNANCY BREAST FEEDING
EFAVIRENZ
Women with CD4<250 who need ART
EFAVIRENZ
March 2005: SUSTIVA may cause fetal harm when
administered during the first trimester to a pregnant
woman, pregnancy should be avoided in women receiving
SUSTIVA
PREGNANCY RISK PREGNANCY BREAST FEEDING
EFAVIRENZ
Women with CD4>250 who need ART
EFAVIRENZ
NEVIRAPINE
NEVIRAPINENEVIRAPINE
March 2005: Severe, life threatening and
sometimes fatal hepatoxicity in the first 18
weeks has been reported in patients treated
with viramune. Women with CD4> 250
cells/mm3 are at greatest risk.
PREGNANCY RISK PREGNANCY BREAST FEEDING
EFAVIRENZ
WOMEN WITH CD4>250:TREATMENT OPTIONS
EFAVIRENZ
NEVIRAPINE
NEVIRAPINENEVIRAPINE
TRIZIVIR TRIZIVIR TRIZIVIR
Triple NRTI may be good option for chronic
treatment in women who have received single
dose nevirapine
Jourdain,
NEJM, 2004
HIV-2 HIGH PREVALENCE In WEST AFRICA
Current WHO Guidelines: First Line ART
Regimens and HIV-2
First Line Regimen
D4T/3TC/NVP
ZDV/3TC/NVP
D4T//3TC/EFV
ZDV/3TC/EFV
Usage in HIV-2
No
No
No
No
Regimens For HIV-2
Regimen
PI (boosted or unboosted) +2 NRTI
ZDV/3TC/TDF
ZDV/3TC/ ABC
Usage in HIV-2
Yes
Yes
Yes
Research Agenda NRTI Only Regimens
• Quadruple NRTI
• Induction Maintenance
• Refining target population
QUAD NRTI : Abacavir, 3TC, ZDV and
Tenofovir
79
84
74
67
79
60
0
20
40
60
80
100
Overall VL<100,000 VL>100,000
%ofSubjects
<400 c/mL
<50 c/mL
%
%
%
%
%
%
No of 54 19 35
Subjects
Elion, CROI 2004
ESS40013: Intensified Induction/Trizivir
maintenance
Markowitz, JAIDS, 2005
Trizivir + EFV
(N = 448)
Trizivir
(n = 121)
VL < 50 at Week 48
“Intensified Induction”
Maintenance
Trizivir +EFV
(n = 121)
Control
Maintenance
Control
77%
79%
Virologic suppression 48 weeks
Identifying predictors of success in
induction/maintenance
19/19 (100%) with DNA/RNA below median
succeeded in maintenance
•ACTG 343
•Patients remaining on
maintenance therapy with either
IDV or ZDV/3TC
•N= 105
200 Pneumocystis pneumonia
Deep fungal infections
CMV retinitis
M. avium
CD4CellCount
Thrush
Kaposi’s Sarcoma
Lymphoma
50
TIME IN YEARS
10
US, EUROPEAN AND AUSTRALIAN GUIDELINES WERE MADE
FOR THIS HIV COURSE
Toxoplasmosis
TRIZIVIR IS CONSIDERED AN ALTERNATIVE
REGIMEN FOR SELECT CIRCUMSTANCES
Gulick, NEJM, 2004
200 Pneumocystis
Deep fungal infections
CMV retinitis
Penicillium
CD4CellCount
Thrush
Kaposis Sarcoma
Lymphoma
50
TIME IN YEARS
10
Toxoplasmosis
Tuberculosis
Malaria
STI
HEPATITIS
HIV DISEASE PROGRESSION: Global View
SELECT TRIPLE NRTI REGIMENS PROVIDE NEEDED
OPTIONS FOR A GLOBAL HIV TREATMENT
APPROACH AND SHOULD NOT BE DISCARDED

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HIV

  • 1. HAVE WE PREMATURELY DISCARDED TRIPLE NRTI REGIMENS? YES Diane V. Havlir, MD University of California, San Francisco, USA
  • 2. Available and emerging data suggest that select triple NRTI regimens are: •Simple to administer •Associated with respectable HIV RNA reductions and CD4 increases •Safe •Favorable drug interaction profile ZDV + 3TC + ABC ZDV + 3TC + TDF
  • 3. From a global perspective, these combinations may represent some of the best options in some rather large populations: •HIV+TB •Women • Child bearing age, pregnant •Breastfeeding •Persons with HIV-2
  • 4. HIV and TB: How large is this problem? •4 fold increase in TB in some parts of Africa •50-70% TB cases HIV+ •Case fatality rates 20% smear +, 50% smear – •Mean CD4 may be lower than previously thought •Lower penetration of ART in TB patients than meet treatment criteria
  • 5. AT HIGH RISK FOR TB, AND WILL NEED TB AND HIV TREATMENT HAVE CONFIRMED OR SUSPECTED TB,AND NEED TB AND HIV TREATMENT OR
  • 6. Antiretroviral Treatment Challenges with HIV and TB: Drug Interactions and Toxicity • Rifamycin containing regimens are associated with best TB treatment outcome. • Rifampin is the only affordable rifamycin option in most of the world. • Rifampin has significant drug interactions with NNRTIs and PIs. • Drug toxicity may be higher when rifampin is administered with NNRTIs or ritonavir boosted- PIs.
  • 7. Regimen Nevirapine +2 NRTI Disadvantages Decrease in NVP by rifampin Cannot give if CD4 >250 in women Hepatoxicity Rash FIRST LINE HIV TREATMENT REGIMENS* *WHO Guidelines for Resource Limited Settings March 2005: Severe, life threatening and sometimes fatal hepatoxicity in the first 18 weeks has been reported in patients treated with viramune. Women with CD4> 250 cells/mm3 are at greatest risk.
  • 8. Regimen Nevirapine +2 NRTI Efavirenz+2 NRTI Disadvantages Decrease in NVP by rifampin Cannot give if CD4 >250 in women Hepatoxicity Rash Decrease in EFV by rifampin Teratogenic FIRST LINE HIV TREATMENT REGIMENS* March 2005: Severe, life threatening and sometimes fatal hepatoxicity in the first 18 weeks has been reported in patients treated with viramune. Women with CD4> 250 cells/mm3 are at greatest risk. March 2005: SUSTIVA may cause fetal harm when administered during the first trimester to a pregnant woman, pregnancy should be avoided in women receiving SUSTIVA *WHO Guidelines for Resource Limited Settings
  • 9. Regimen PI +2 NRTI Boosted PI +2 NRTI Disadvantages PI levels decrease by >70%, cannot use Toxicity Drug interactions Cost Cold chain /Refrigeration ALTERNATIVE REGIMENS
  • 10. Ritonavir-Saquinavir and Rifampin interaction • Recent drug interaction warning issued • HIV- volunteers received 100/1000 rit/SQV and rifampin 600 mg • Study stopped prematurely • 39% developed hepatocellular toxicity • Elevations up to 20 times upper normal of limit of liver tests were observed Rifampin SHOULD NOT be administered to patients receiving saquinavir/ritonavir as part of combination antiretroviral therapy for HIV infection* *Roche, Dear Doctor letter, Feb , 2005
  • 11. TRIPLE NRTI REGIMEN FOR PATIENTS RECEIVING TB TREATMENT ZDV + 3TC + ABC ZDV + 3TC + TDF ADVANTAERegimen Advantage •NO DRUG INTERACTIONS WITH TB MEDS •NOT TERATOGENIC •LESS RISK THAN NNRTI FOR HIV RESISTANCE WITH TREATMENT INTERRUPTIONS •FAMILY BASED CARE •NO DRUG INTERACTIONS WITH TB MEDS •NO RASH •LESS RISK THAN NNRTI FOR HIV RESISTANCE WITH TREATMENT INTERRUPTIONS
  • 12. WOMEN: SIGNIFICANT LIMITATIONS OF FIRST LINE REGIMENS Courtesy of Dr. El Sadr
  • 13. 1. Women at risk for pregnancy who need ART 2. Pregnant and breastfeeding women who need ART 3. Pregnant and breastfeeding women who need ART to prevent perinatal transmission only 4. Women who need chronic ART who harbor nevirapine resistant virus SIGNIFICANT LIMITATIONS OF FIRST LINE REGIMENS : 4 GROUPS
  • 14. PREGNANCY RISK PREGNANCY BREAST FEEDING EFAVIRENZ Women with CD4<250 who need ART EFAVIRENZ March 2005: SUSTIVA may cause fetal harm when administered during the first trimester to a pregnant woman, pregnancy should be avoided in women receiving SUSTIVA
  • 15. PREGNANCY RISK PREGNANCY BREAST FEEDING EFAVIRENZ Women with CD4>250 who need ART EFAVIRENZ NEVIRAPINE NEVIRAPINENEVIRAPINE March 2005: Severe, life threatening and sometimes fatal hepatoxicity in the first 18 weeks has been reported in patients treated with viramune. Women with CD4> 250 cells/mm3 are at greatest risk.
  • 16. PREGNANCY RISK PREGNANCY BREAST FEEDING EFAVIRENZ WOMEN WITH CD4>250:TREATMENT OPTIONS EFAVIRENZ NEVIRAPINE NEVIRAPINENEVIRAPINE TRIZIVIR TRIZIVIR TRIZIVIR
  • 17. Triple NRTI may be good option for chronic treatment in women who have received single dose nevirapine Jourdain, NEJM, 2004
  • 18. HIV-2 HIGH PREVALENCE In WEST AFRICA
  • 19. Current WHO Guidelines: First Line ART Regimens and HIV-2 First Line Regimen D4T/3TC/NVP ZDV/3TC/NVP D4T//3TC/EFV ZDV/3TC/EFV Usage in HIV-2 No No No No
  • 20. Regimens For HIV-2 Regimen PI (boosted or unboosted) +2 NRTI ZDV/3TC/TDF ZDV/3TC/ ABC Usage in HIV-2 Yes Yes Yes
  • 21. Research Agenda NRTI Only Regimens • Quadruple NRTI • Induction Maintenance • Refining target population
  • 22. QUAD NRTI : Abacavir, 3TC, ZDV and Tenofovir 79 84 74 67 79 60 0 20 40 60 80 100 Overall VL<100,000 VL>100,000 %ofSubjects <400 c/mL <50 c/mL % % % % % % No of 54 19 35 Subjects Elion, CROI 2004
  • 23. ESS40013: Intensified Induction/Trizivir maintenance Markowitz, JAIDS, 2005 Trizivir + EFV (N = 448) Trizivir (n = 121) VL < 50 at Week 48 “Intensified Induction” Maintenance Trizivir +EFV (n = 121) Control Maintenance Control 77% 79% Virologic suppression 48 weeks
  • 24. Identifying predictors of success in induction/maintenance 19/19 (100%) with DNA/RNA below median succeeded in maintenance •ACTG 343 •Patients remaining on maintenance therapy with either IDV or ZDV/3TC •N= 105
  • 25. 200 Pneumocystis pneumonia Deep fungal infections CMV retinitis M. avium CD4CellCount Thrush Kaposi’s Sarcoma Lymphoma 50 TIME IN YEARS 10 US, EUROPEAN AND AUSTRALIAN GUIDELINES WERE MADE FOR THIS HIV COURSE Toxoplasmosis
  • 26. TRIZIVIR IS CONSIDERED AN ALTERNATIVE REGIMEN FOR SELECT CIRCUMSTANCES Gulick, NEJM, 2004
  • 27. 200 Pneumocystis Deep fungal infections CMV retinitis Penicillium CD4CellCount Thrush Kaposis Sarcoma Lymphoma 50 TIME IN YEARS 10 Toxoplasmosis Tuberculosis Malaria STI HEPATITIS HIV DISEASE PROGRESSION: Global View
  • 28. SELECT TRIPLE NRTI REGIMENS PROVIDE NEEDED OPTIONS FOR A GLOBAL HIV TREATMENT APPROACH AND SHOULD NOT BE DISCARDED

Editor's Notes

  1. On this slide, the red bars represent the % of subjects with VL &lt;400 c/mL and the yellow bars represent % with VL &lt;50 c/mL At week 24, 79% of subjects achieved VL &lt;400 c/mL and 67% of subjects achieved VL &lt;50 c/mL. In the low baseline VL group, 84% of subjects were below 400 c/mL and 79% were below 50 c/mL. In the high baseline VL group, 74% were below 400 c/mL and 60% were below 50 c/mL.
  2. Finally, data were presented on an induction/maintenance strategy using fixed-dose zidovudine/lamivudine/abacavir. In this study, approximately 450 treatment-naive patients were given zidovudine/lamivudine/abacavir plus efavirenz for 48 weeks as induction therapy. Those patients who had viral loads &lt; 50 copies/mL at 48 weeks were then randomized to either maintenance therapy with just zidovudine/lamivudine/abacavir or continued therapy with efavirenz plus zidovudine/lamivudine/abacavir. At 48 weeks, only 282 of the original 448 patients were available for randomization, and were then monitored for an additional 48-week period. The results demonstrated that zidovudine/lamivudine/abacavir maintenance therapy was not inferior—in other words, it was quite similar—to continued therapy with zidovudine/lamivudine/abacavir plus efavirenz. At 96 weeks, 79% of the patients who received zidovudine/lamivudine/abacavir and efavirenz and 77% of the patients who received zidovudine/lamivudine/abacavir only had viral loads &lt; 50 copies/mL in an intention to treat, missing = failure analysis. There were more virologic failures in the zidovudine/lamivudine/abacavir-only arm, but this difference did not reach statistical significance, and there were more dropouts in the arm in which patients continued both efavirenz and zidovudine/lamivudine/abacavir. In addition to having similar antiviral activity, the zidovudine/lamivudine/abacavir arm demonstrated reductions in fasting total cholesterol and fasting LDL cholesterol, with a 22 mg/dL reduction in fasting cholesterol between 48 and 96 weeks. There was also a trend toward improved self-reported adherence in the patients who were maintained on zidovudine/lamivudine/abacavir alone.