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Rate of Stopping Atripla for Side
Effects Steady Through 96 Weeks in London Cohort
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51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 17-20, 2011, Chicago
Mark Mascolini
Stopping Atripla because of central nervous system (CNS) toxicity (usually attributed to efavirenz) persisted in a large London cohort through 96 weeks of follow-up, at a quitting rate of almost 1 case per week. More than 80% of people who quit Atripla because of CNS side effects did so after tolerating the drug for 3 months. Among people who kept taking Atripla for 12 months, almost everyone had an undetectable viral load and triglyceride levels did not change.
Clinicians at London's Chelsea and Westminster Hospital tracked everyone in their cohort who began Atripla (efavirenz plus tenofovir/emtricitabine in a single once-daily pill) as their first-line antiretroviral combination. They also assessed duration of treatment and reasons for quitting in everyone who stopped Atripla. The analysis excluded people who started efavirenz and tenofovir/emtricitabine separately then switched to Atripla.
The study involved 472 people who started Atripla, 442 of them (94%) male, 354 (75%) white, and 246 (52%) men who have sex with men. Median age when treatment began was 37 years (interquartile range [IQR] 31 to 43), median CD4 count 285 (IQR 208 to 362) and median viral load 16,000 copies (IQR 708 to 54,000). Nonwhites included small minorities of black Africans, other blacks, Asians, and people of mixed race.
Almost 98% (463 people) took Atripla for 6 months, and 81% (383) continued the three-in-one tablet for 12 months. Among people who continued Atripla, median CD4 count rose to 387 (IQR 297 to 492) at month 6 and to 449 (IQR 327 to 536) at month 12. After 6 months of Atripla, 92% of those who kept taking Atripla had a viral load below 50 copies/mL, and after 12 months 98% still taking Atripla had a sub-50-copy viral load.
Median total cholesterol climbed from 4.3 mmol/L (166 mg/dL) before treatment began to 4.7 mmol/L (182 mg/dL) at month 6 and to 4.8 mmol/L (186 mg/dL) at month 12. Median triglycerides stood at 1.6 mmol/L (142 mg/dL) before treatment began and at 1.5 mmol/L (133 mg/dL) at months 6 and 12.
During follow-up 89 of 472 people (19%) stopped Atripla after a median duration of 294 days (almost 10 months, IQR 108 to 495). CNS toxicity explained 63 (71%) of the discontinuations, while liver toxicity accounted for 7 (8%), rash for 6 (7%), virologic failure and/or resistance for 6 (7%), and pregnancy for 3 (3%). Insomnia, nightmares, depression, and dizziness were the most common CNS side effects.
Among 63 people who quit taking Atripla because of CNS toxicity during the first 96 weeks of treatment, 6 (10%) stopped in the first 4 weeks, 4 (6%) in weeks 4 to 12, 30 (48%) in weeks 12 to 52, and 23 (36%) in weeks 52 to 96. Thus most people (84%) who stopped Atripla because of CNS toxicity did so after the first 3 months of therapy.
Reference
1. Zheng J, Scourfield A, Waters L, et al. Discontinuation of tenofovir, emtricitabine and efavirenz as a single tablet regime in HIV-1 infected individuals naive to antiretroviral therapy. 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). September 17-20, 2011. Chicago. Abstract H2-783.
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