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 HIV and Hepatitis.com Coverage of the
5
th IAS Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2009)
 July 19 - 22, 2009, Cape Town, South Africa
 The material posted on HIV and Hepatitis.com about IAS 2009 is not approved by nor is it a part of IAS 2009.
Nevirapine (Viramune) Has Equal Efficacy but a More Favorable Lipid Profile Compared with Boosted Atazanavir (Reyataz)

ARTEN is an international, non-inferiority study comparing ritonavir-boosted atazanavir (Reyataz/r) versus nevirapine (Viramune), each combined with fixed-dose tenofovir/emtricitabine (Truvada). Week 48 results presented in a late-breaker session at the 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009) in Cape Town last week showed that nevirapine offers equal efficacy, with a more favorable lipid profile, compared with boosted atazanavir. Although the 2 regimens had similar rates of adverse events, discontinuations occurred more frequently in patients taking nevirapine.

By Ronald Baker, PhD

The ARTEN trial included 569 treatment-naive HIV patients who were randomly assigned to received 300/100mg once-daily (QD) atazanavir/ritonavir or nevirapine administered either 200 mg twice-daily (BID) or 400 mg once-daily, each in combination with the fixed-dose 300/200 mg once-daily tenofovir/emtricitabine combination pill (Truvada). This is the first study to compare these 2 antiretroviral drugs.

Baseline demographics characteristic and HIV-related factors were similar in the 2 groups. The mean HIV viral load was >100,000 copies/mL and the mean CD4 count was 183 cells/mm3.

The primary end-point was treatment response (TR), defined as plasma HIV-RNA < 50 copies/mL at 2 consecutive visits without subsequent rebound or change of antiretroviral drugs prior to week 48.

Results

67% of the 376 patients who received nevirapine achieved the primary endpoint, compared with 65% of the 193 patients who received atazanavir/ritonavir (P = 0.63).
The mean increase from baseline in high-density lipoprotein (HDL "good") cholesterol was 9.6 mg/dL in the nevirapine arm and 4.0 mg/dL in the atazanavir/ritonavir arm (P < 0.0001).
The mean increase in low-density lipoprotein (LDL "bad") cholesterol was 15 mg/dL in the nevirapine group and 10.5 mg/dL in the atazanavir/ritonavir group (P = 0.011).
Triglyceride (TG) levels decreased by a mean 1.4 mg/dL from baseline in the nevirapine group, while increasing by 26.5 mg/dL in the atazanavir/ritonavir group (P < 0.0001).

Table 1: Week-48 results (Intent-to-treat analysis)

Parameter

Nevirapine (N=376)
 (188 BID + 188 QD)

Atazanavir/ritonavir (N=193)

Comparison
 (95% CI)

% TR (Primary end-point)

66.8

64.8

2.5 (-5.4 to 10.4)

% TR (TLOVR algorithm)*

70.2

73.6

-2.9 (-10.4 to 4.5)

TC/HDL-ratio mean change from baseline

-0.23

+0.13

P=0.0001

HDL mean change from baseline (mg/dL)

9.6

4.0

P<0.0001

TG mean change from baseline (mg/dL)

+1.4

+26.5

P=0.0001

% Overall adverse events (grades 3 and 4)

85.6 (12.0 and 5.1)

86.5 (16.1 and 3.1)

n/a

% Rash, all grades (discontinued)

16.0 (5.6)

12.4 (0)

n/a

% Discontinuations due to adverse events

12.5

3.6

n/a

BID = once-daily; QD =  once-daily; TC = total cholesterol
* Time to loss of virological response; HIV RNA < 50 copies/mL at wks-36 and 48 without subsequent rebound or change of antiretroviral drugs.

Based on these findings, the investigators concluded, "Nevirapine shows non-inferior efficacy at week-48 versus atazanavir/ritonavir (both combined with fixed-dose [tenofovir/emtricitabine]). Despite similar rates of adverse events, discontinuations were more frequent in nevirapine than in atazanavir/ritonavir patients. Nevirapine demonstrated a more favourable lipid profile than atazanavir/ritonavir."

Lead investigator Vicente Soriano from Hospital Carlos III in Madrid, Spain, said, "[This study] puts to rest the concerns over a potential lack of efficacy of nevirapine in combination with tenofovir/emtricitabine, and confirms that the combination of nevirapine and tenofovir/emtricitabine is a highly efficacious combination that offers significant benefit -- even more so to patients with cardiovascular risk."

7/28/09

Reference
V Soriano, S Koeppe, H Mingrone, and others. Prospective comparison of nevirapine and atazanavir/ritonavir both combined with tenofovir DF/emtricitabine in treatment-naïve HIV-1 infected patients: ARTEN study week 48 results. 5th International AIDS Society Conference on HIV Pathogenesis, Treatment, and Prevention (IAS 2009). Cape Town, South Africa. July 19-22, 2009. Abstract LBPEB07.


 

 

 

 

 

 

 

 

 

 

 

 

 

 




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