abacavir and Nausea

Twice-daily darunavir/ritonavir is indicated in treatment-experienced children (≥3 years). This study assessed once-daily administration in treatment-naïve adolescents.. Phase 2, 48-week, open-label, single-arm study evaluating pharmacokinetics, safety and efficacy of once-daily darunavir/ritonavir 800/100 mg in treatment-naïve, HIV-1-infected adolescents (≥12 to <18 years, ≥40 kg) with zidovudine/lamivudine or abacavir/lamivudine.. Twelve patients (67% female; median 14.4 years) were enrolled. After 24 and 48 weeks, respectively, 11 of 12 (92%) and 10 of 12 (83%) patients achieved viral load <50 copies/mL (intent-to-treat time-to-loss of virologic response); all had ≥1 log10 drop in viral load versus baseline. Median CD4 cell count increased by 175 and 221 cells/mm (intent-to-treat-noncompleter = failure) after 24 and 48 weeks, respectively. Eighty-three percent of patients were adherent to darunavir/ritonavir. One patient was never suppressed and 1 patient rebounded. No patients developed darunavir resistance-associated mutations or lost phenotypic susceptibility to any commercially available protease inhibitor or any background nucleoside reverse transcriptase inhibitor. Eleven patients (92%) reported ≥1 adverse event (AE), considered in 2 patients to be at least possibly related to darunavir (gastrointestinal-related events and dizziness). Four patients had ≥1 serious AE. Three patients reported ≥1 grade 3/4 AE; no serious or grade 3/4 AEs were considered darunavir related. No patients discontinued because of AEs.. Over 48 weeks, once-daily darunavir/ritonavir 800/100 mg plus NRTIs was effective and well-tolerated for treatment of HIV-1-infected, antiretroviral-naïve adolescents (≥12 to <18 years). These findings support use of once-daily darunavir/ritonavir 800/100 mg in this population.

Topics: Adolescent; Anemia; CD4 Lymphocyte Count; Darunavir; Dideoxynucleosides; Drug Resistance, Viral; Drug Therapy, Combination; Female; HIV Infections; HIV Protease Inhibitors; HIV-1; Humans; Lamivudine; Male; Medication Adherence; Nausea; Neutropenia; Reverse Transcriptase Inhibitors; Ritonavir; Sulfonamides; Time Factors; Viral Load; Vomiting; Zidovudine

Highly active antiretroviral therapy (HAART); the-current standard of antiretroviral therapy for Human Immunodeficiency Virus (HIV) infected persons, has been documented to drastically, reduce the number of cases of Acquired Immune Deficiency Sypdrome (AIDS). However, adverse. events are a challenge to the use of HAART. This study intends to determine the nature and incidence of suspected advcrse events to prescribed anti retroviral drugs in treatment centers in Ekiti State.. One hundred and twenty participants were enrolled and followed up over a period of six months. At each clinic visit, there was an administration of a detailed interviewer questionnaire that was completed by the attending pharmacist together with the participant. The form is designed to obtain information on the demographics of the patients, WHO clinical stage of their HIV infection, HAART regimen for the patients, and suspected adverse events associated with the antiretroviral drugs used by the patients.. Tenofovir/Lamivudine/Eifavirenz (72.5%), Zidovudinc/Lamiv.udin/Nevirapine (16.7%), Zidovudine/Lamivudiine/ElafIvirenz (6.7%), Tenofovir/ Lamivudine/Nevirapine (3.3%), and Abacavir/ Lamivudine/Nevirapine (0.8%) were the HAART regimens prescribed to the patients. About half (57%) of the participants reported clinical adverse events; 92% of which were reported within two weeks of HAART initiation. Most of the reported adveise events were nausea (14.5%), abdominal discomfort (8.2%), and insomnia (7.5%). A few (6%) of those who reported adverse events required regimen switch or drug substitution.. Antiretroviral drugs exposure often presents with adverse events, an observation similar to other studies. Most of the clinical adverse events were not severe or life threatening.

Topics: Abdominal Pain; Adolescent; Adult; Alkynes; Anti-HIV Agents; Antiretroviral Therapy, Highly Active; Benzoxazines; Cyclopropanes; Dideoxynucleosides; Drug Substitution; Drug Therapy, Combination; Female; HIV Infections; Humans; Incidence; Lamivudine; Male; Middle Aged; Nausea; Nevirapine; Nigeria; Prospective Studies; Sleep Initiation and Maintenance Disorders; Tenofovir; Young Adult; Zidovudine