Lamivudine (Page 6 of 8)

14.2 Pediatric Subjects

Clinical Endpoint Trial ACTG300 was a multicenter, randomized, double-blind trial that provided for comparison of lamivudine plus RETROVIR (zidovudine) with didanosine monotherapy. A total of 471 symptomatic, HIV-1-infected therapy-naive (less than or equal to 56 days of antiretroviral therapy) pediatric subjects were enrolled in these 2 treatment arms. The median age was 2.7 years (range: 6 weeks to 14 years), 58% were female, and 86% were non-white. The mean baseline CD4+ cell count was 868 cells per mm 3 (mean: 1,060 cells per mm 3 and range: 0 to 4,650 cells per mm 3 for subjects aged less than or equal to 5 years; mean: 419 cells per mm 3 and range: 0 to 1,555 cells per mm 3 for subjects aged over 5 years) and the mean baseline plasma HIV-1 RNA was 5.0 log 10 copies per mL. The median duration on trial was 10.1 months for the subjects receiving lamivudine plus RETROVIR and 9.2 months for subjects receiving didanosine monotherapy. Results are summarized in Table 11.

Table 11. Number of Subjects (%) Reaching a Primary Clinical Endpoint (Disease Progression or Death)


Lamivudine plus RETROVIR (n = 236)

Didanosine (n = 235)

HIV-1 disease progression or death (total)

15 (6.4%)

37 (15.7%)

Physical growth failure

7 (3.0%)

6 (2.6%)

Central nervous system deterioration

4 (1.7%)

12 (5.1%)

CDC Clinical Category C

2 (0.8%)

8 (3.4%)


2 (0.8%)

11 (4.7%)

Once-Daily Dosing ARROW (COL105677) was a 5-year randomized, multicenter trial which evaluated multiple aspects of clinical management of HIV-1 infection in pediatric subjects. HIV-1-infected, treatment-naïve subjects aged 3 months to 17 years were enrolled and treated with a first-line regimen containing lamivudine and abacavir, dosed twice daily according to World Health Organization recommendations. After a minimum of 36 weeks on treatment, subjects were given the option to participate in Randomization 3 of the ARROW trial, comparing the safety and efficacy of once-daily dosing with twice-daily dosing of lamivudine and abacavir, in combination with a third antiretroviral drug, for an additional 96 weeks. Of the 1,206 original ARROW subjects, 669 participated in Randomization 3. Virologic suppression was not a requirement for participation: at baseline for Randomization 3 (following a minimum of 36 weeks of twice-daily treatment), 75% of subjects in the twice-daily cohort were virologically suppressed, compared with 71% of subjects in the once-daily cohort.

The proportion of subjects with HIV-1 RNA of less than 80 copies per mL through 96 weeks is shown in Table 12. The differences between virologic responses in the two treatment arms were comparable across baseline characteristics for gender and age.

Table 12. Virologic Outcome of Randomized Treatment at Week 96 * (ARROW Randomization 3)
Analyses were based on the last observed viral load data within the Week 96 window.
Predicted difference (95% CI) of response rate is -4.5% (-11% to 2%) at Week 96.
Includes subjects who discontinued due to lack or loss of efficacy or for reasons other than an adverse event or death, and had a viral load value of greater than or equal to 80 copies per mL, or subjects who had a switch in background regimen that was not permitted by the protocol.
Other includes reasons such as withdrew consent, loss to follow-up, etc. and the last available HIV-1 RNA less than 80 copies per mL (or missing).


Lamivudine plus Abacavir Twice-Daily Dosing (n = 333)

Lamivudine plus Abacavir Once-Daily Dosing (n = 336)

HIV-1 RNA <80 copies/mL



HIV-1 RNA ≥80 copies/mL



No virologic data

Discontinued due to adverse event or death



Discontinued study for other reasons §



Missing data during window but on study



Analyses by formulation demonstrated the proportion of subjects with HIV-1 RNA of less than 80 copies per mL at randomization and Week 96 was higher in subjects who had received tablet formulations of lamivudine and abacavir (75% [458/610] and 72% [434/601]) than in those who had received solution formulation(s) (with lamivudine solution given at weight band-based doses approximating 8 mg per kg per day) at any time (52% [29/56] and 54% [30/56]), respectively [see Warnings and Precautions ( 5.5)]. These differences were observed in each different age group evaluated.


Lamivudine Tablets USP, 150 mg (Scored) are white to off-white, film-coated, oval shaped tablets, debossed with ‘52’ and ‘Y’ on either side of the score line on one side and plain with a score line on the other side.
Unit dose packages of 30 (3 x 10) NDC 60687-362-21

Recommended Storage:
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

FOR YOUR PROTECTION: Do not use if blister is torn or broken.

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