Treatment experience in South Africa. Dr Ian Sanne Clinical HIV Research Unit University of the Witwatersrand

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1 Treatment experience in South Africa Dr Ian Sanne Clinical HIV Research Unit University of the Witwatersrand

2 Overview South African Prevalence Adherence Combination ddi + d4t Nevirapine Hepatotoxicity National roll-out regimens

3 South African HIV epidemic National prevalence 12% Highest in age groups years Upto 33% prevalence in ANC 350,000 orphans rising to 700,000 by % of all deaths in country are AIDS related. Higher in age group

4 Activities of the unit ARV studies since 1998 Videx EC, Zerit XR, Atazanavir, Kaletra, Phos Amprenavir, In combinations with D4T + 3TC AZT + 3TC ddi + d4t Efavirenz and Nevirapine

5 Patients recruited Predominantly public sector patients Often from very poor socio-economic circumstances English is predominant consent language

6 Overview South African Prevalence Adherence Combination ddi + d4t Nevirapine Hepatotoxicity National roll-out regimens

7 Adherence 96 weeks Factors that do not influence adherence Women Men Social circumstances Only teenagers were problem but sample very small Distance from clinic did not influence

8 96 weeks of treatment Adherence rates (n=480) Proportion >100% 3.5% >95% 82% 80-95% 13% <80% 2.5%

9 Overview South African Prevalence Adherence Combination ddi + d4t Nevirapine Hepatotoxicity National roll-out regimens

10 ACTG 384: Design 980 Antiretroviral naïve subjects (<7 days prior ART) HIV-1 viral load >500 copies/ml Stratification: HIV RNA: <10,000, 10, ,000, >100,000 c/ml Country: US, Italy ddi+d4t ZDV+3TC EFV A (155) C (155) NFV B (155) D (155) NFV+EFV E (178) F (182)

11

12 Units experience with ddi +d4t BMS 008 study ddi + d4t + ATZ or NFV (n=80) 23% switch of ddi + D4T to AZT + 3TC, peripheral neuropathy, lactic acidaemia One cranial nerve demyelinating neuropathy death due to aspiration pneumonia One death in pregnant woman related to lactic acidosis Overall proportion <400c/ml at 3 years 85%. (OTT)

13 Overview South African Prevalence Adherence Combination ddi + d4t Nevirapine Hepatotoxicity National roll-out regimens

14 FTC-302 Study Design Randomized (1:1), double-blind equivalence trial of emtricitabine (FTC) vs. Lamivudine (3TC) in ART naïve subjects Background of stavudine (d4t) and either: Nevirapine (NVP) for VL < 100,000 copies/ml Efavirenz (EFV) for VL > 100,000 copies/ml 468 subjects randomized and received at least 1 dose of blinded study drug Subjects were followed every 4 weeks to Week 48 and every 12 weeks thereafter until last subject reached Week 48.

15 Number of Subjects Evaluated Stratum FTC 3TC Total Nevirapine Efavirenz Total Sanne et al NEJM in press

16 G3/4 Hepatotoxicities (%) by Stratum and Treatment Arm % Emtricitabine Lamivudine Total Efavirenz Nevirapine P =.27 comparing emtricitabine vs lamivudine within nevirapine stratum Sanne et al NEJM in press

17 Cumulative Frequency (n) of G3/4 Hepatotoxicities by Week of Study FTC 3TC W4 W12 W20 W28 W32 W48 Total Sanne et al NEJM in press

18 Disposition of Subjects with G3/4 Hepatotoxicities (N=64) Percent Grade 4 Grade Total Treated Interrupt Interrupt/ Permanent through With Successful Un successful discontinuation Toxicity Re-introduction Re-introduction

19 Evaluation of Predictive Factors Age Race / Ethnicity Gender Body Mass Index CD4+ cells at entry Plasma HIV-1 RNA at entry Liver enzyme abnormalities at entry Blinded study medication (FTC/3TC) Sanne et al NEJM in press

20 Subject Characteristics by Presence of Hepatotoxicity (1) Characteristic Yes No (n=64) (n=321) p-value Median Age NS % Black NS % Female <0.03 Median BMI NS Median CD4+ (Min Max) HIV-1 RNA % with > grade 1 hepatic abnormalities at baseline (1) Nevirapine stratum only 375 ( ) ( ) NS NS NS

21 Clinical Characteristics of Subjects With G3/G4 Hepatotoxicities 77% of hepatotoxicities occurred within the first 4 weeks 36% of subjects had GI symptoms 34% of hepatotoxicities included G3/G4 bilirubin 31% had rash that was temporally associated with hepatotoxicity 6% of subjects were HBsAg-positive at screening, 2 of 57 (3.5%) subjects tested had evidence of HBV replication; 3% of subjects had serological evidence of HCV infection prior to hepatotoxicity No association with blinded study medication, viral load load at study entry, alcohol use, parasitic disease, or diet and traditional medication use Sanne et al NEJM in press

22 Deaths Attributed to Hepatitis (n=2) Subject #1143; Nevirapine + d4t + FTC 26 YO BF Baseline CD4+ = 400 cells/mm3 and HIV-1 RNA = 9,388 cps/ml Nausea and weakness on Day 24 DC d study medications on Day 26 Hospitalized on Day 27 with G4 liver enzyme elevations Pneumonia on Day 31 Death due to cardiopulmonary arrest on Day 32 Sanne et al NEJM in press

23 Deaths Attributed to Hepatitis (n=2) Subject #2192; Nevirapine + d4t + 3TC 37 YO BF Baseline CD4+ = 424 cells/mm3 and HIV-1 RNA = 70,480 cps/ml G2 rash without systemic symptoms on Day 16 Severe vomiting and diarrhea on Day 23 DC d study medications and hospitalized with presumptive gastroenteritis, pneumonia (coughing and tachypnea) and G4 liver enzyme elevations on Day 29 Hepatic encephalopathy on Day 34; HBsAG+ with negative HBV-DNA on Day 35 Death due to cardiopulmonary arrest on Day 32

24 Incidence of Hepatotoxicities (%) with 95% Confidence Interval in Other NVP Clinical Trials 40 N=1103 N=98 N=155 N=100 N=71 N= Percent % 8 % 16 % % % % 0 BI 1090 INCAS BI pooled* VIRGO Atlantic FTC-302 All G3-4 All G3-4 All G3-4 All G2-4 All G3-4 All G3-4 NRTIs: 3TC/bkg NUC ZDV/ddI ZDV/PBO d4t/ddi d4t/ddi d4t/3tc or FTC *unpublished data provided by Boehringer Ingelheim

25 Conclusions Hepatotoxicities were observed in 64/385 (17%) of nevirapine treated and 0/83 Efavirenz treated subjects in combination with d4t/3tc or FTC There was no significant difference (p=0.27) observed between FTC (14%) and 3TC (19%) treated subjects Within the nevirapine treated subjects, the incidence was nearly twice as high in females (20%) as in males (12%); no other variables were predictive of hepatotoxicity. Overall observed frequency of hepatotoxicities is consistent with other published and unpublished studies of nevirapine. Liver enzymes in subjects receiving nevirapine should be monitored closely, particularly during the first four weeks with continued monitoring thereafter.

26 Overview South African Prevalence Adherence Combination ddi + d4t Nevirapine Hepatotoxicity National roll-out regimens

27 National Roll-out Regimen 1 NB First line D4T + 3TC + NVP or EFV EFV not in pregnancy NVP associated with Hepatotoxicity and EN and SJS An increased dose of EFV is recommended when combined with Rifampicin

28 National Roll-out Regimen 2 NB AZT + ddi + Kaletra Kaletra double dose is recommended with Rifampicin.

29

30 Overview South African Prevalence Adherence Combination ddi + d4t Nevirapine Hepatotoxicity National roll-out regimens IRIS Syndrome

31 Immune reconstitutions Syndrome TB IR 12 cases Presenting within 4 weeks of treatment initiation Associated with significant rise in CD4 count Baseline clinical exam and CXR did not predict Fever in first 4 weeks only predictor 2 deaths 1 pulmonary and 1 menigitis

32 Overview South African Prevalence Adherence Combination ddi + d4t Nevirapine Hepatotoxicity National roll-out regimens IRIS Syndrome Atazanavir and Kaletra

33 BMS-008/044 Trial Design BMS AI BMS AI ATV 400 mg qd ATV 400 mg qd ATV 600 mg qd ATV 600 mg qd NFV 1250 mg bid ATV 400 mg qd Plus d4t (Patients 60 kg, 40 mg bid; < 60 kg, 30 mg bid) and 3TC 150 mg bid

34 BMS-008/044 Patient Characteristics BMS-044: NLF to ATV ATV, mg NFV ATV Total AI Treated, n Completed, n AI Enrolled/treated, n Baseline characteristics Age, mean, yr Male, % White, % HIV RNA, median, log 10 c/ml HIV RNA <400 c/ml, % CD4 count, median, cells/mm

35 BMS-008/044 Virologic Response: 044 Entry and Wk 24 ITT Analysis 100 <400 c/ml <50 c/ml BMS-044: NLF to ATV Entry Week 24 Responders (%) ATV 400 ATV 600 NFV ATV 400 ATV 400 ATV 600 NFV ATV 400 AI /044 selected cohort

36 BMS-008/044 Virologic Response: 044 Entry and Wk 24 As-Treated Analysis <400 c/ml <50 c/ml BMS-044: NLF to ATV Entry Week 24 Responders (%) ATV 400 ATV 600 NFV ATV 400 AI /044 selected cohort ATV 400 ATV 600 NFV ATV 400 Number with measurements 129/ /139 60/62 129/ /139 60/62

37 Kaletra 20 patient recruited in Jhb 18 patients taken over from a site in CT 100% undetectable viral loads in black patients at 3 years No significant lipid changes in first 2 years 1 case of increased TG in year 3 but also only grade 2.

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