This study aims to evaluate the clinical efficacy of AV2 antiviral drug as a treatment for HPV-associated lesions of the uterine cervix; to Identify HPV genotypes found in Kinshasa and to determine the cost-effectiveness of an algorithm combining screening by VIA and AV2 and that combining VIA and cryotherapy treatment;After basic training of local health workers on VIA, on collection of cervical samples for HPV testing and liquid-based cytology (LBC) and on application of AV2, a screening and treatment program will be offered to women aged 25 and older who will give their informed consent. All women with lesions on VIA will be randomized into one of two groups to receive either treatment by AV2 or placebo. All women with lesions on VIA will be monitored and reviewed after two months and after six months for repeat tests (VIA, LBC, HPV testing).
The study has been approved by both the Ethics Committees of the University of Antwerp and of the University of Kinshasa, and is registered with ClinicalTrials.gov under identifier NCT02346227.
Background and Rationale
Women in the Democratic Republic of the Congo (DRC), Cervical cancer (CC) remains the first most common cancer diagnosed in with an estimated number of 3839 cases per year. Vaccination against human papillomavirus (HPV), the main cause of CC, has not been introduced yet in DRC. Cytology screening is opportunistic due to high cost, lack of infrastructure and scarcity of cytotechnicians. Data on the epidemiology of circulating HPV types is limited and the strains involved in invasive CC are not known in the DRC.
Main objective: to contribute to the improvement of cervical cancer prevention and control strategies in low-resource settings.
- to assess the clinical efficacy of the viricide AV2® in the topical treatment of HPV-associated lesions of the uterine cervix;
- to assess the prevalence and the distribution of HPV genotypes in a community of Kinshasa, DRC.
Design and methods
A phase 2 clinical trial first assessed the efficacy and safety of the antiviral AV2® in the treatment of cervical colposcopic lesions. Then a phase 3 randomized clinical trial (RCT) on the efficacy of AV2® in the treatment of HPV-associated precancerous lesions of the cervix was conducted. The main outcome was the regression of cervical lesions after the application of the topical drug AV2®.
Efficacy of AV2®
In the phase 2 clinical trial AV2®, application of AV2® resulted in regression of lesions in 21 out of 28 (75%) women, compared to 0% (0 out of 5) in the placebo group. The difference between the two groups was statistically significant (p < 0.001).
During the phase 3 RCT, 327 women were enrolled. At 2 months, regression of lesions occurred in 127 (89.4%) out of 142 women in AV2® group compared to 120 (91.6%) out of 131 women in the placebo group (P = 0.708).
Prevalence and genotype distribution of HPV in a community of Kinshasa
The overall HPV prevalence was 28.2 %. Women younger than 30 years had the highest prevalence (42.2%). HPV68 was the most prevalent genotype. HPV genotypes distribution was different from other regions of the world.
Conclusion and perspectives for research
The high prevalence of HPV-related cervical diseases warrants improvement of the health system and the need for a nationwide and sustainable implementation of cervical cancer control strategies in DRC. Assessment of HPV genotypes involved in invasive CC will help in the design of future vaccines.