Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2013 Apr 30;16(1):18059.
doi: 10.7448/IAS.16.1.18059.

Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts

Eric Ouattara  1 , Christine Danel, Raoul Moh, Delphine Gabillard, Gilles Peytavin, Romuald Konan, Jérome Le Carrou, Franck Bohoussou, Serge P Eholie, Xavier Anglaret
Affiliations
Randomized Controlled Trial

Early upper digestive tract side effects of zidovudine with tenofovir plus emtricitabine in West African adults with high CD4 counts

Eric Ouattara et al. J Int AIDS Soc. .

Abstract

Introduction: Tenofovir (TDF) with emtricitabine (FTC) and zidovudine (ZDV) is a recognized alternate first-line antiretroviral (ART) regimen for patients who cannot start treatment with non-nucleoside reverse transcriptase inhibitors (NNRTIs). Clinical studies comparing TDF+FTC+ZDV to other regimens are lacking.

Methods: Participants in a trial of early ART in Côte d'Ivoire (Temprano ANRS 12136) started treatment with TDF/FTC plus either efavirenz (EFV) or ZDV (HIV-1+2 dually infected patients and women refusing contraception or previously treated with nevirapine). We compared rates of upper digestive serious adverse events (sAEs) between TDF/FTC+EFV and TDF/FTC+ZDV patients during the first six months of treatment. sAEs were defined as either grade 3-4 AEs or persistent grade 1-2 AEs leading to drug discontinuation.

Results: A total of 197 patients (76% women, median CD4 count 395/mm(3)) started therapy with TDF/FTC, 126 with EFV and 71 with ZDV. During the first six months of ART, 94 patients had digestive AEs (nausea/vomiting) of any grade (EFV 36/126, 29%; ZDV 58/71, 82%, p<0.0001), including 20 sAEs (EFV 3/126, 5%; ZDV 17/71, 24%, p<0.0001). In-patients on TDF/FTC+ZDV with digestive AEs, the median time to the first symptom was two days (IQR: 1-4). Plasma ZDV (Cmax) distributions and pill ZDV dosages were normal. Patients with digestive AEs had higher haemoglobin levels and tended to have higher body mass indices and more frequent past histories of cotrimoxazole (CTX) prophylaxis.

Conclusions: We observed an unexpectedly high rate of digestive sAEs in West African adults, mostly women, who started a 3-nuc ART with TDF/FTC+ZDV in Côte d'Ivoire. These adults were participating in a trial of early ART and had much higher CD4 counts than those who currently routinely start ART in sub-Saharan Africa. They all received CTX concomitantly with ZDV. We suggest that further early prescriptions of TDF+XTC+ZDV should be carefully monitored and that whenever possible, the rate of early upper digestive adverse events should be compared to that occurring in-patients taking other drug regimens.

Clinical trial number: NCT00495651.

Keywords: 3 nucleoside reverse transcriptase inhibitors; HIV infection; adults; antiretroviral treatment; early treatment; side effects; sub-Saharan Africa; tolerance.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Early drug discontinuation and viral load suppression at six months in patients who started ART with TDF-FTC-EFV or TDF-FTC-ZDV. LTFU: lost-to-follow-up; M6: Month-6.
See this image and copyright information in PMC

References

    1. Toure S, Kouadio B, Seyler C, Traore M, Dakoury-Dogbo N, Duvignac J, et al. Rapid scaling-up of antiretroviral therapy in 10,000 adults in Cote d'Ivoire: 2-year outcomes and determinants. Aids. 2008;22(7):873–82. - PMC - PubMed
    1. Mills EJ, Bakanda C, Birungi J, Mwesigwa R, Chan K, Ford N, et al. Mortality by baseline CD4 cell count among HIV patients initiating antiretroviral therapy: evidence from a large cohort in Uganda. Aids. 2011;25(6):851–5. - PubMed
    1. Lawn SD, Harries AD, Anglaret X, Myer L, Wood R. Early mortality among adults accessing antiretroviral treatment programmes in sub-Saharan Africa. Aids. 2008;22(15):1897–1908. - PMC - PubMed
    1. WHO. Antiretroviral therapy for HIV infection in adults and adolescents: recommendations for a public health approach. 2010 revision. [cited 2011 May 12]. Available from: http://whqlibdoc.who.int/publications/2010/9789241599764_eng.pdf. - PubMed
    1. Cuzin L, Pugliese P, Bugnon F, Delpierre C, Cua E, Billaud E, et al. Triple nucleoside reverse transcriptase inhibitor vs. non-nucleoside reverse transcriptase inhibitor-containing regimens as first-line therapy: efficacy and durability in a prospective cohort of French HIV-infected patients. HIV Med. 2005;6(6):388–95. - PubMed

Publication types

MeSH terms

Associated data