Efficacy, adherence and tolerability of once daily tenofovir DF-containing antiretroviral therapy in former injecting drug users with HIV-1 receiving opiate treatment: results of a 48-week open-label study.
OBJECTIVE
To assess efficacy, adherence and tolerability of once daily antiretroviral therapy containing tenofovir disoproxil fumarate (DF) 300 mg in HIV-1-infected former injecting drug users receiving opiate treatment (IVDU).


METHODS
European, 48-week, open-label, single-arm, multicenter study. Patients were either antiretroviral therapy-naive, restarting therapy after treatment discontinuation without prior virological failure or switching from existing stable treatment.


RESULTS
Sixty-seven patients were enrolled in the study and 41 patients completed treatment. In the primary analysis (intent-to-treat missing=failure) at week 48, 34% of patients (23/67; 95% CI: 23%-47%) had plasma HIV-1 RNA <50 copies/mL. Using an intent-to-treat missing=excluded approach, the week 48 proportion of patients with plasma HIV-1 RNA <50 copies/mL increased to 56% (23/41; 95% CI: 40%-72%). Mean (standard deviation) increase from baseline in CD4+ cell count at week 48 was 176 (242) cells/mm(3). Although self-reported adherence appeared high, there were high levels of missing data and adherence results should be treated with caution. No new safety issues were identified.


CONCLUSIONS
Levels of missing data were high in this difficult-to-treat population, but potent antiretroviral suppression was achieved in a substantial proportion of HIV-infected IVDU-patients.
Department of Dermatology and Venereology, Universitätsklinikum Essen, Hufelandstr. 55, 45122 Essen, Germany. Stefan.Esser@uk-essen.de
S
S
Esser
A
A
Haberl
F
F
Mulcahy
J
J
Gölz
A
A
Lazzarin
E
E
Teofilo
J
J
Vera
A
A
Körber
S
S
Staszewski
D000225:Adenine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use; D019380:Anti-HIV Agents / Q000627:therapeutic use*; D023241:Antiretroviral Therapy, Highly Active; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000821:virology; D015497:HIV-1 / Q000187:drug effects* / Q000235:genetics / Q000472:pathogenicity; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D055118:Medication Adherence; D008691:Methadone / Q000627:therapeutic use*; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use*; D015819:Substance Abuse, Intravenous / Q000188:drug therapy*; D015996:Survival Rate; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
D000701:Analgesics, Opioid; D019380:Anti-HIV Agents; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine; D008691:Methadone