Prognostic value of virological and immunological responses after 6 months of antiretroviral treatment in adults with HIV-1 infection in sub-Saharan Africa.
BACKGROUND
HIV RNA monitoring is not available in most antiretroviral treatment (ART) programs in sub-Saharan Africa; switch to second-line therapy is mostly guided by clinical/immunological criteria. This may lead to unnecessary disease progression and drug resistance accumulation. We investigated the prognostic value of virological and immunological status 6 months after ART initiation with respect to death, loss to follow-up, and treatment switch.


METHODS
We considered treatment-naive HIV-1-infected patients, starting ART with available 6-month visit and subsequent follow-up, enrolled in a prospective cohort comprising 5 ART sites in 3 sub-Saharan countries. Outcome measures included the time from 6-month visit to death for all causes, loss to follow-up, and switch to second line.


RESULTS
Of 2539 patients, 62% were females, their median pre-ART CD4 count was 215 cells per microliter, median HIV RNA 4.6 Log10 copies per milliliter, 30% were on WHO stage 3/4. At 6 months, 85% had HIV RNA <1000 copies per milliliter. During 3112 person-years follow-up after the 6-month visit, 91 patients died. Death was predicted by 6-month HIV RNA ≥10,000 copies per milliliter, adherence, and 6-month CD4 <200 cells per microliter. The 2-year estimated probability of surviving ranged from 0.69 (with 6-month HIV RNA ≥10,000 and CD4 <200) to 0.95 (with HIV RNA <1000 and CD4 ≥200). Loss to follow-up (1.95 per 100 person-years follow-up) was predicted by the 6-month HIV RNA >10,000 copies per milliliter and adherence but not by CD4. Switch to second line (6.94 per 100 person-years follow-up) was predicted by 6-month HIV RNA and CD4.


CONCLUSIONS
In patients starting ART in sub-Saharan Africa, 6-month HIV RNA independently predicts subsequent survival, retention to care, and switch to second-line therapy. This measure warrants further evaluation as specific time point monitoring option.
Institute of Clinical Infectious Diseases, Catholic University, Rome, Italy. deluca.andrea@fastwebnet.it
Andrea
A
De Luca
Maria Cristina
MC
Marazzi
Sandro
S
Mancinelli
Susanna
S
Ceffa
Anna Maria Doro
AM
Altan
Ersilia
E
Buonomo
Mattia Carlo Felice
MC
Prosperi
Barbara
B
Pedruzzi
Abdul Majid
AM
Noorjehan
Paola
P
Scarcella
Giuseppe
G
Liotta
Leonardo
L
Palombi
D000328:Adult; D017954:Africa South of the Sahara / Q000453:epidemiology; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D015331:Cohort Studies; D004334:Drug Administration Schedule; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology* / Q000401:mortality / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000276:immunology*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D010349:Patient Compliance; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012367:RNA, Viral / Q000737:chemistry / Q000235:genetics; D019562:Viral Load
D019380:Anti-HIV Agents; D012367:RNA, Viral