Abstract
ObjectivesTwo nucleos(t)ide reverse-transcriptase inhibitors (NRTIs) plus 1 non-NRTI (nNRTI) remain the preferred or alternative combination antiretroviral therapy (cART) for antiretroviral-naive HIV-positive patients in Taiwan. The three most commonly used nNRTIs are nevirapine (NVP), efavirenz (EFV) and rilpivirine (RPV). This study aimed to determine the incidences of hepatotoxicity and skin rashes within 4 weeks of initiation of cART containing 1 nNRTI plus 2 NRTIs.MethodsBetween June, 2012 and November, 2015, all antiretroviral-naive HIV-positive adult patients initiating nNRTI-containing cART at 8 designated hospitals for HIV care were included in this retrospective observational study. According to the national HIV treatment guidelines, patients were assessed at baseline, 2 and 4 weeks of cART initiation, and subsequently every 8 to 12 weeks. Plasma HIV RNA load, CD4 cell count and aminotransferases were determined. The toxicity grading scale of the Division of AIDS (DAIDS) 2014 was used for reporting clinical and laboratory adverse events.ResultsDuring the 3.5-year study period, 2,341 patients initiated nNRTI-containing cART: NVP in 629 patients, EFV 1,363 patients, and RPV 349 patients. Rash of any grade occurred in 14.1% (n = 331) of the patients. In multiple logistic regression analysis, baseline CD4 cell counts (per 100-cell/μl increase, adjusted odds ratio [AOR], 1.125; 95% confidence interval [95% CI], 1.031–1.228) and use of NVP (AOR, 2.443; 95% CI, 1.816–3.286) (compared with efavirenz) were independently associated with the development of skin rashes. Among the 1,455 patients (62.2%) with aminotransferase data both at baseline and week 4, 72 (4.9%) developed grade 2 or greater hepatotoxicity. In multiple logistic regression analysis, presence of antibody for hepatitis C virus (HCV) (AOR, 2.865; 95% CI, 1.439–5.704) or hepatitis B surface antigen (AOR, 2.397; 95% CI, 1.150–4.997), and development of skin rashes (AOR, 2.811; 95% CI, 1.051–7.521) were independently associated with the development of hepatotoxicity.ConclusionsThe baseline CD4 cell counts and use of NVP were associated with increased risk of skin rashes, while hepatotoxicity was independently associated with HCV or hepatitis B virus coinfection, and development of skin rashes in antiretroviral-naïve HIV-positive Taiwanese patients within 4 weeks of initiation of nNRTI-containing regimens.
Highlights
In multiple logistic regression analysis, presence of antibody for hepatitis C virus (HCV) (AOR, 2.865; 95% 95% confidence interval (CI), 1.439–5.704) or hepatitis B surface antigen (AOR, 2.397; 95% CI, 1.150–4.997), and development of skin rashes (AOR, 2.811; 95% CI, 1.051–7.521) were independently associated with the development of hepatotoxicity
The baseline CD4 cell counts and use of NVP were associated with increased risk of skin rashes, while hepatotoxicity was independently associated with HCV or hepatitis B virus coinfection, and development of skin rashes in antiretroviral-naïve HIV-positive Taiwanese patients within 4 weeks of initiation of nucleoside reverse transcriptase inhibitor (nNRTI)-containing regimens
In recent practice guidelines of first-line antiretroviral treatment of HIV infection, the preferred or alternative combination antiretroviral therapy regimens include a combination of two nucleo(t)side reverse-transcriptase inhibitors (NRTIs) plus an active drug from one of the following classes: integrase strand transfer inhibitor (INSTI), ritonavir-boosted protease inhibitor (PI) [1,2,3], non-nucleoside reverse transcriptase inhibitor[3]
Summary
In recent practice guidelines of first-line antiretroviral treatment of HIV infection, the preferred or alternative combination antiretroviral therapy (cART) regimens include a combination of two nucleo(t)side reverse-transcriptase inhibitors (NRTIs) (tenofovir disoproxil fumarate [TDF] and emtricitabine or lamivudine) plus an active drug from one of the following classes: integrase strand transfer inhibitor (INSTI), ritonavir-boosted protease inhibitor (PI) [1,2,3], non-nucleoside reverse transcriptase inhibitor (nNRTI) (efavirenz [EFV] [2] or rilpivirine [RPV])[3]. The choice of first-line therapy is determined based on various considerations, which include safety, drug tolerability, transmission of drug-resistant HIV-1 in the untreated population, coinfections, such as tuberculosis [5] and viral hepatitis, pregnancy, comorbidities, concurrent medications, or availability of antiretroviral agents. The antiretroviral regimens containing the first-generation nNRTIs, EFV and NVP, have been shown to be efficacious and safety in different populations [7, 8]. NVP is the preferred nNRTI in the first-line antiretroviral regiments in pregnancy because of substantial clinical experience in pregnant women and its proven efficacy in reducing mother-to-child transmission [12, 13]; higher incidences of rash, Stevens-Johnson syndrome, and hepatotoxicity have been associated with NVP than EFV [7, 14,15,16,17]
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